Behestan Darou News

U.S. FDA Approves ELIQUIS® (apixaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

Tue, 15 Jan 2013 00:00:00 GMT

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY ) and Pfizer Inc. (NYSE: PFE ) announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS® (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Atrial fibrillation, the most common type of irregular heartbeat, affects approximately 5.8 million people in the U.S., and results in a five times greater risk of stroke. In the U.S., 15 percent of strokes are attributable to atrial fibrillation.

“The approval of ELIQUIS offers patients with nonvalvular atrial fibrillation a novel treatment option for reducing the risk of stroke,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “ELIQUIS is the result of leading scientific innovation and the shared vision of our alliance to introduce a new oral anticoagulant for patients with nonvalvular atrial fibrillation in the U.S.”
Ian Read, chairman and chief executive officer, Pfizer Inc. said, “The profile of ELIQUIS, combined with the strong legacy and complementary capabilities that Pfizer and Bristol-Myers Squibb have in the cardiovascular space, positions us well to deliver this important new treatment option to patients and health care professionals.”
The ELIQUIS clinical trial program is the largest completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients; it included two landmark Phase 3 studies -- ARISTOTLE and AVERROES -- in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE evaluated ELIQUIS versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and AVERROES evaluated ELIQUIS versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin.
The Full Prescribing Information for ELIQUIS includes a Boxed Warning for patients who discontinue treatment. Patients on ELIQUIS who discontinue treatment are at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.
ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Please see additional Important Safety Information included in this release.
“With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin,” said Christopher Granger, M.D., Professor of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., ARISTOTLE lead investigator. “ELIQUIS represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.”
ELIQUIS is an oral Factor Xa inhibitor anticoagulant. By inhibiting Factor Xa, a key blood clotting protein, ELIQUIS decreases thrombin generation and blood clot formation.ELIQUIS does not require routine monitoring using International Normalized Ratio (INR) or other tests of coagulation and there are no known dietary restrictions. ELIQUIS can be taken with or without food.
ELIQUIS is expected to be widely available in the U.S. by the end of January 2013.

new

Fri, 21 Dec 2012 00:00:00 GMT

hhh

new news1

Sat, 15 Dec 2012 00:00:00 GMT

Milan, 23 November 2012 – Recordati announces that its subsidiary Orphan Europe and Erytech Pharma, a late development stage French biopharmaceutical company focused on orphan oncology and rare diseases, have entered into an agreement granting Orphan Europe the exclusive rights for the commercialization and distribution of Graspa® for the treatment of Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) in Europe. Graspa®, human erythrocytes encapsulating L-asparaginase, for the treatment of hematological malignancies, is currently in pivotal Phase II/III clinical trial for ALL and will enter a Phase IIb trial in AML in Europe. The product has obtained an orphan drug designation in Europe and the USA for ALL.

Top-line results from Pfizer's pregabalin CR formulation Phase 3 study on fibromyalgia

Mon, 26 Nov 2012 00:00:00 GMT

Pfizer Inc. (NYSE: PFE) today announced that top-line results of a double-blind, Phase 3 study evaluating pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicate that pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR). Fibromyalgia is a common pain condition in the United States, affecting more than five million Americans. It is characterized by chronic widespread pain and tenderness lasting for three or more months.

This study is the second of three Phase 3 studies of the pregabalin CR formulation to report top-line findings, which will ascertain the potential use of pregabalin as a once-a-day therapy. The top-line results of the first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. The final study in post-herpetic neuralgia is ongoing. Pfizer will analyze further results of all three studies once data are available.

"Collectively, the results of these controlled release studies will allow us to better understand the potential of a once-a-day pregabalin treatment regimen," said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. "Reducing the number of times patients need to take their medicine per day while maintaining the same efficacy and safety profile could potentially provide a greater convenience and the potential to enhance treatment adherence and outcomes."

Janssen receives positive opinion from EMA CHMP for ZYTIGA to treat mCRPC

Mon, 26 Nov 2012 00:00:00 GMT

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA® (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. If endorsed by the European Commission, the recommendation would expand the indication for ZYTIGA®, which is currently approved for use in combination with prednisone/prednisolone to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the Phase III COU-AA-302 study on which this CHMP recommendation is based after a pre-specified analysis found statistically significant differences in radiographic progression-free survival (rPFS) and a strong trend in overall survival (OS) favouring ZYTIGA®. Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA®. Patients in the ZYTIGA arm also demonstrated a statistically significant difference in all the secondary endpoints compared to the control arm.

The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in early 2013.

Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented, "This positive opinion brings us a step closer to being able to offer ZYTIGA® to advanced cancer patients earlier in the course of their disease and fills a previously unmet medical need. If approved, the expanded indication will provide a welcome new option for patients with castration-resistant prostate cancer. It could not only give men a chance of extended survival, but may also delay the need for chemotherapy and help to improve their quality of life."

We are pleased to announce that on July 31, 2012, the Kedrion Group finalized the acquisition of the RhoGAM® line of products from Ortho-Clinical Diagnostics, Inc. (OCD).

Wed, 31 Oct 2012 00:00:00 GMT

We are pleased to announce that on July 31, 2012, the Kedrion Group finalized the acquisition of the RhoGAM® line of products from Ortho-Clinical Diagnostics, Inc. (OCD). The transaction includes the transfer of Rho(D) Immune Globulin (Human) RhoGAM® Ultra-Filtered PLUS and Rho(D) Immune Globulin (Human) MICRhoGAM® Ultra-Filtered PLUS products and the acquisition of Somerset Laboratories, Inc., a wholly owned subsidiary of Ortho Clinical Diagnostics that is a US FDA-licensed donation center located in Williamsville, NY.

The transition is effective immediately. Ortho Clinical Diagnostics will continue to manufacture the products and work closely with us to ensure a smooth transition so there will be no changes in either your access to the RhoGAM® line of products or other services. For Ortho-Clinical Diagnostics Technical Services call 800-421-3311 and for Customer Service call 800-828-6316 or visit www.RhoGAM.com.

Our Commitment to You: The Kedrion Group is committed to maintaining the legacy of the RhoGAM® Brand so patients around the world have access to this critically important product that prevents hemolytic disease of the newborn (HDN) and has been saving babies’ lives for more than 40 years. All of us at Kedrion are focused on maintaining the integrity of the safety and efficacy of the RhoGAM® line of products and the quality service upon which you, along with tens of thousands of obstetricians and gynecologists, nurses, midwives, blood bankers and Rh-negative women, have come to associate with it.

About the Kedrion Group: Kedrion S.p.A. is a fully owned subsidiary of Kedrion Group headquartered in Italy, in the province of Lucca, and well known for plasma derived products, including those for the treatment of hemolytic disease of the newborn, hemophilia and immune deficiencies. Kedrion Biopharma is the US subsidiary established in 2011, specializing in marketing and distributing products to the US market. Our focus is on improving quality of life and our continual diligence addresses the medical needs of both international and local communities with a relentless commitment to education, research and development.

Through our US subsidiary in Fort Lee, NJ, Kedrion has been marketing and distributing our human antihemophilic factor Koate®-DVI; Albuked®, albumin (Human), and Kedbumin™, albumin (Human), both sterile preparations of albumin protein in an aqueous solution administered intravenously; and Gammaked™, an intravenous immune globulin. In 2011, Kedrion acquired from Grifols two collection centers and, with the acquisition of Somerset Laboratories, now has nine collection centers in the US.

We are very excited about this opportunity to work along with the Rh-negative mothers, their families, physicians and you in your endeavors to prevent Rh-related hemolytic disease of the newborn around the world. We will continue to be in touch with you, but please don’t hesitate to contact my colleagues or me at Kedrion. For more information about Kedrion, please visit www.KedrionUSA.com or call 201-242-8900.

Sincerely,

Paolo Marcucci, President and CEO
Kedrion Biopharma, Inc.
________________________________________

Azerbaijan earth quake

Mon, 24 Sep 2012 00:00:00 GMT

Disasters—whether natural or man-made—strike with unyielding fervor, leveling everything in their paths and destroying life, property and livelihood. They wreak havoc on the poor, who are often defenseless against their coming and are pushed further into poverty after they leave. They affect countless people each year, striking when least expected and leaving when little is left.

Azerbaijan earthquake reminded us once more of this tragedy that befells on our fellow countrymen from time to time.

Thanks to the management and personnel of Behestan Darou andf Behestan Pakhsh, we were able to take a small step in alleviating the pain of those in need.

We hope that this spirit and humanitarian effort would last for a long time.

Astellas Pharma receives FDA approval for Myrbetriq to treat overactive bladder

Fri, 29 Jun 2012 00:00:00 GMT

The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive

bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.

An extended-release tablet taken once daily, Myrbetriq improves the storage capacity of the bladder by relaxing the bladder muscle during filling.

Symptoms of overactive bladder include the need to urinate too often (urinary frequency), the need to urinate immediately (urinary urgency), and the involuntary leakage of urine as a result of the need to urinate immediately (urge urinary

incontinence).

"An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious," said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Today's approval provides a new treatment option for patients with this debilitating condition."

Myrbetriq's safety and efficacy were demonstrated in three double-blind, placebo-controlled, multicenter clinical trials. A total of 4,116 patients with overactive bladder were randomly assigned to take Myrbetriq at doses of 25 milligrams, 50 mg, 100 mg, or a

placebo once daily for 12 weeks.

Results showed that Myrbetriq 25 mg and 50 mg effectively reduced the number of times a patient urinated and the number of times a patient had wetting accidents during a 24-hour period. Patients taking Myrbetriq 50 mg also expelled

a greater amount of urine, demonstrating the drug's effectiveness in improving the storage capacity of the bladder.

The most common side effects observed in the trials were increased blood pressure, common cold-like symptoms nasopharyngitis), urinary tract infection, constipation, fatigue, elevated heart rate (tachycardia), and abdominal pain. Myrbetriq is not recommended for use in those with severe uncontrolled high blood pressure, end stage kidney disease or severe liver impairment.

Myrbetriq is marketed by Astellas Pharma US, Inc. of Northbrook, Ill.

Source: http://www.fda.gov

Final results from MSD’s VICTRELIS plus PEGINTRON Phase III trial on HCV treatment-related anemia

Wed, 20 Jun 2012 00:00:00 GMT

MSD (NYSE: MRK), known as Merck in the United States and Canada, announced final results from a Phase III, open-label study designed to       compare the impact of two anaemia management strategies on sustained   virologic response (SVR) in patients with chronic hepatitis   C virus (HCV) genotype 1 infection treated with VICTRELIS®(boceprevir) in combination with PEGINTRON® (known as       VIRAFERONPEG® in some countries) (peginterferon alfa-2b) and       ribavirin (P/R). The rates of SVR were 71 percent for both groups: those       patients whose anaemia was managed by ribavirin dose reduction (178/249)       and those patients whose anaemia was managed by the addition of       erythropoietin (EPO) (178/251). The rates of relapse were identical at       10 percent in both groups. These results were presented today for the       first time as part of a late breaker poster session [poster #1419] at       The International Liver Congress™ / 47th European Association for the       Study of the Liver (EASL) annual meeting.

"Chronic hepatitis C treatment regimens with peginterferon alfa and       ribavirin are commonly associated with

the development of anaemia, and       this effect is further increased with the addition of boceprevir,"

said       Fred Poordad, M.D., chief of hepatology and liver transplantation,       Cedars-Sinai Medical Center, Los Angeles. "The results of this study       show there was no difference in SVR rates among these anaemia management    strategies and that ribavirin dose reduction should be the primary       strategy for managing anaemia in patients taking boceprevir combination

therapy."

Source: Merck

Turning Interdisciplinary Brain Tumor Science into Survival; Report from the Neuro-Oncology Scientific Club Opening Session, NOSC 2012 -19 January- Tehran, IR Iran

Sat, 25 Feb 2012 00:00:00 GMT

On the 19 January 2012, the opening session of the interval meetings of the Neuro-Oncology Scientific Club (NOSC-THN) was held in Tehran, Iran. The NOSC is a newlyestablished scientific forum which currently has formed provincial steering boards in the country and is expected to be turned to the national NOSC in its future perspective. The interdisciplinary nature of this club provides a multifaceted approach for diagnosis, treatment and follow-up of brain tumor patients. Participants utilized this transparent and unbiased round table to contribute to discussions and decisions. All comments were open to debate, with interdisciplinary team work for brain tumor patients’ health and quality of life at the center. This paper summarizes the communicated insights (neurosurgery,radiodiagnostics and radiochemotherapy) and the suggested strategies during the first NOSC-Tehran meeting hoping to let readers further perceive the significance of the interdisciplinary approach as a practical model in CNS tumor patients’ care.

To view the article’s full text and the journal front page simply click on the bellow links or copy and paste them it in your browser.

Full text PDF quick link:

http://www.sciencepub.net/report/report0402/007_8292report0402_42_53.pdf

Journal front page:

http://www.sciencepub.net/report/report0402

Quit-smoking drug Chantix effective in cocaine and alcohol addiction

Sat, 18 Feb 2012 00:00:00 GMT

Two new studies have suggested that the controversial anti-smoking drug varenicline (Chantix) may also help people fight cocaine and alcohol addictions.

The first study, published this month in the journal Alcohol and Drug Dependence, was a nine-week clinical trial that included 37 people with cocaine addiction. Researchers at the University of Pennsylvania found that participants who took varenicline were half as likely to use cocaine — as measured by urine tests three times a week — as those given placebo.

Additionally the participants drank less alcohol while on varenicline. Further, in an experiment in which participants were given a choice between cocaine and money in varying sums, people taking varenicline valued cocaine less than those on placebo, suggesting that the quit-smoking drug made cocaine less rewarding.

The second study will soon be published in the Alcoholism: Clinical and Experimental Research. It involved 15 moderate to heavy social drinkers.

While taking varenicline, they, too, found their drug of choice to be less enjoyable and more unpleasant. This comports with anecdotal reports of smokers who have told researchers that they found alcohol less desirable and therefore

drank less while using varenicline to quit smoking.

“A single medication that could decrease the use of both substances would be ideal,” said Hugh Myrick, associate professor of psychiatry at the Medical university of South Carolina and co-author of the drinking study, said in a statement, noting that many people are addicted to both alcohol and cocaine.

But varenicline is not without a downside. It carries a black box warning from the FDA because of serious psychiatric side effects, including suicidal thoughts and behavior. One study found that people taking varenicline to quit smoking were eight times more likely to engage in suicidal or self-injuring behavior than those using nicotine-replacement treatments like the patch. Other

research has linked varenicline to an increased risk of heart problems in people with pre-existing cardiovascular

disease, although the risk-benefit calculation here is complicated by the fact that smoking carries far greater risk to the heart and blood vessels than varenicline.

EMA CHMP issues positive opinion to MSD's REMICADE for treatment of pediatric UC

Thu, 02 Feb 2012 00:00:00 GMT

MSD (also known as Merck in the United States and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE®

(infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an

inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. REMICADE, a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, was approved in the European Union (EU) in March 2006 for the treatment of moderately to severely active UC in adults. REMICADE has been used in the treatment of inflammatory bowel disease (IBD) for more than 12 years in the EU, having been first approved for severely active Crohn's disease in adults in 1999, and more recently, moderately to severely active pediatric Crohn's disease in 2007.

Upon receipt of the corresponding Commission Decision, REMICADE will be the first and only biologic therapy approved in the EU for the treatment of pediatric UC, a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.

"For parents of children who suffer from the sometimes devastating effects of ulcerative colitis, the positive opinion adopted by the CHMP is encouraging news and a significant step towards making REMICADE available to a younger patient population in Europe," said Rupert Vessey, MRCP, DPhil, Senior Vice President, Research Laboratories, Merck. "Building on our

long heritage in immunology, today's positive opinion further reinforces the efficacy of REMICADE in the treatment of inflammatory bowel disease and our commitment to expanding treatment options for patients in Europe."

The CHMP adopted their opinion based on a review of data from a Phase 3 multicenter, randomized, open-label, parallel-group clinical study that assessed the efficacy and safety of REMICADE in 60 pediatric patients ages 6 through 17 years diagnosed with moderately to severely active ulcerative colitis who had experienced an inadequate response to conventional therapies. Findings from the 54-week study showed the efficacy of REMICADE in this pediatric population.

A final decision from the European Commission is expected during the first quarter of 2012.

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine as a single dose for adults

Sun, 01 Jan 2012 00:00:00 GMT

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.

"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the United States. The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans," said Ian Read, chairman and chief executive officer, Pfizer Inc. "This approval is representative of Pfizer's dedication to discovering and bringing to market life-changing medicines and vaccines." Pneumococcal disease (PD) is a leading public health issue in adults 50 years of age and older, a population rapidly increasing in the United States. In this population, there are estimated to be hundreds of thousands of S. pneumoniae infections per year, including more than 440,000 cases of pneumococcal pneumonia, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalizations. "Clearly, there remains a high incidence of pneumococcal pneumonia in this adult population," said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. "Prevnar 13 was licensed for adults 50 years and older by the FDA under an accelerated approval pathway because of its potential to help address this significant disease burden."

Pfizer is currently conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) to fulfill requirements under the accelerated approval pathway. CAPiTA is an efficacy trial involving more than 84,000 subjects designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia (CAP) caused by the 13 pneumococcal serotypes contained in the vaccine. In addition, Pfizer has agreed, as a post-marketing commitment in connection with the approval by the U.S. FDA, to conduct a study evaluating concomitant use of Prevnar 13 and TIV (annual trivalent inactivated influenza vaccine) in adults 50 years of age and older who have been previously immunized with PPSV.

"As adults grow older they become more susceptible to infectious diseases, such as pneumococcal pneumonia, due to their aging immune systems," said Thomas M. File, Jr., M.D., M.S., president-elect, National Foundation for Infectious Diseases. "As a conjugate vaccine, Prevnar 13 offers an important new option for adults 50 years and older to include as part of their preventive strategy for healthy aging." In addition to the United States, Pfizer has been granted approval for use of Prevnar 13 for various indications in adults 50 years of age and older in the European Union, Australia, Mexico and more than 10 other countries. Prevnar 13 was first approved by the U.S. FDA in February 2010 for the prevention of invasive pneumococcal disease in infants and young children from 6 weeks through 5 years of age.

No link between Chantix and mental health problems says FDA

Sat, 05 Nov 2011 00:00:00 GMT

According to federal health officials this Monday Pfizer's anti-smoking drug Chantix – known as Varenicline, did not increase

psychiatric problems like depression and suicidal thoughts in two studies, though the findings are not definitive.

Chantix works by binding to the same spots in the brain that nicotine does when people smoke, blocking nicotine from those spots but causing release of a “feel-good” chemical, dopamine. The drug's label already carries a boxed warning, the most serious type, listing possible side effects including hostility, agitation, depression and suicidal thoughts and behavior.

The Food and Drug Administration have been investigating reports of mood disorders and erratic behavior among Chantix

patients since 2007. The agency said in a statement that two federally-funded studies involving more than 26,000 patients did not show an increased rate of psychiatric hospitalizations among Chantix patients, compared with those using

nicotine patches and smoking cessation treatments.

The Veterans Affairs study included 14,131 Chantix users and an equal number of nicotine replacement therapy users. Sixteen

Chantix-treated patients were hospitalized for psychiatric reasons compared to 21 in the replacement therapy group.

The Pentagon studied 11,978 Chantix users and an equal number of replacement therapy patients. Patients on Chantix were hospitalized 18 times for psychiatric reasons compared to 16 times among replacement therapy patients.

However the FDA mentioned that the studies only recorded psychiatric problems that resulted in hospitalization, meaning many

issues likely went unreported. Additionally, the studies by the Department of Veterans Affairs and the Department of Defense were not large enough to pick up very rare side effects. Groups like the Federal Aviation Administration have already banned the drug for pilots and air traffic controllers due to side effects that could interfere with their work.The agency is continuing to study the problems and recommends patients consult their doctors if they experience side effects with the drug. Pfizer is conducting its

own large-scale study of Chantix behavioral effects, but the results won't be available until 2017.

“Healthcare professionals should advise patients and caregivers that the patient should immediately stop taking Chantix and contact a healthcare professional if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed,” the FDA said in an online statement.

More than 8.9 million people in the U.S. have filled prescriptions for Chantix since it was approved in May 2006. Last year Pfizer

reported $755 million in sales for the drug, a decline of 14 percent since its peak sales of $883 million in 2007.

“We are reviewing this important information for smokers provided by the FDA,” MacKay Jimeson, a spokesman for Pfizer said.

“Given the significant public health risks of smoking, Chantix is an important treatment option for adult smokers to help patients stop smoking.”

Pfizer's Prevnar 13: Additional data from adult clinical studies presented at 49th IDSA

Sat, 22 Oct 2011 00:00:00 GMT

Pfizer Inc. (NYSE:PFE) announced today that additional data from several clinical studies of Prevnar 13^®(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) conducted in adults 50 years and older will be presented during the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA), which is being held Oct. 20-23, 2011, in Boston, Mass. The data from these studies provide support for the pending regulatory applications for the use of Prevnar 13 in adults 50 years and older to help prevent pneumococcal disease.

More About the Prevnar 13 Adult Clinical Studies

Poster Title: A Phase 3, Open-label Trial Evaluating the Safety and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine (PCV13) in Elderly Adults Who Received PCV13 Followed by 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) in a Prior Trial

Presentation #664, Pneumococcal Vaccines Poster Session, Friday, October 21, 12:15-2:15 p.m. (ET)

Poster Title: A Phase 3, Randomized, Active-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Sequential Administration of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) Administered at 1-Year Intervals in PPSV23-naïve Adults 60-64 Years of Age

Presentation #665, Pneumococcal Vaccines Poster Session, Friday, October 21, 12:15-2:15 p.m. (ET)

Poster Title: 13-valent Pneumococcal Conjugate Vaccine (PCV13) Enhances the Response to Subsequent PCV13 and 23-valent Pneumococcal Polysaccharide (PPSV23) Vaccinations in Adults 50 Years and Older

Presentation #LB-3, Late Breaker Poster Session, Saturday, October 22, 11:45 a.m.-1:45 p.m. (ET)

Scientific Leaders Meeting, Protease Inhibitors in Hepatitis C, Local consensus from Iran.

Mon, 22 Aug 2011 00:00:00 GMT

Following the FDA approval of BOCEPREVIR (VICTRELIS) in treating naïve and treatment experienced genotype 1 Chronic Hepatitis C (CHC) patients in 13th May 2011, There raised subsequent queries on when this therapeutic option is going to be available in Iran and in which patient category we should use triple therapy with Boceprevir?( i.e. PegIFN alfa/ Ribavirin plus VICTRELIS). Iran Hepatitis Network which is led by Prof. Alavian (Baghiatollah Medical University) has tried to integrate all hepatitis field research centers in Iran and has come up with great achievements so far.

The authorities of this network proposed conduction of a scientific leaders meeting in Iran, through which they can arrive at a national consensus after which to be the point of reference and guideline for whoever needs to consider protease inhibitors in treating challenging hepatitis C patients. Below is a brief overview on the rationale of using VICTRELIS in Hepatitis C as per the FDA statements. VICTRELIS is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:

1- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
2- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
3- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2-log10 HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included subjects who were poorly interferon responsive. Subjects with less than 0.5-log10 HCV-RNA decline in viral load at Treatment Week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than 2-log10 viral load decline at Treatment Week 12) to peginterferon alfa and ribavirin therapy.
4- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin. Coming back to the scientific leaders meeting we held on 28th July; this meeting hosted 55 attendees.

The meeting invitees were high profile experts in the field of hepatitis. They were invited from nearly all main research centers, institutes and universities in Tehran plus provinces like Shiraz, Isfahan, Yazd, Kermanshah, Zahedan, Mashhad, Rasht and main academic centers which are active in hepatitis field . There was a core scientific panel as well as number of collaborators and consultancy committee who actively shared ideas and analyzed thoughts and debates through evidence based approach and in round table format.

Former smokers with lung cancer can benefit from celecoxib treatment

Tue, 12 Jul 2011 00:00:00 GMT

Celecoxib may emerge as a potent chemopreventive agent for lung cancer, according to a recent study in Cancer Prevention Research, a journal of the American Association for Cancer Research.Researchers tested celecoxib, a COX-2 inhibitor, among patients who were former smokers and found a significant benefit in bronchial health as measured by the Ki-67 labeling index, a marker of cellular proliferation or growth, as well as a number of other biomarkers. The findings follow a previous report published in Cancer Prevention Research that showed a similar effect on Ki-67 among former smokers and current smokers (Kim et al., Feb. 2010).

"Taken together, these findings strongly suggest that celecoxib can be used as a chemopreventive agent in these high-risk groups," said Jenny Mao, M.D., a professor of medicine at the University of New Mexico and section chief of pulmonary and critical care medicine at the New Mexico VA Health System.

Mao cautioned, however, that both the current study, where she was the lead researcher, and the Feb. 2010 study were phase II trials, and that large phase III trials are still needed to confirm the findings. J. Jack Lee, Ph.D., a professor of biostatistics at The University of Texas M. D. Anderson Cancer Center and the statistical editor of Cancer Prevention Research, estimates that there are currently 45 million former smokers and 45 million current smokers in the United States alone.

"The oncology community does not have a good treatment for lung cancer. Unless it is caught in the earliest stages, the five-year survival is only about 15 percent," said Lee. "The best way is to intercept at the earliest stages and try to reverse the processes that can lead to cancer.

These studies suggest celecoxib may be a tool to do that." For the current study, Mao and colleagues enrolled 137 patients and randomly assigned them to 400 mg celecoxib twice daily or a placebo. Patients had to be at least 45 years old, and had to

have stopped smoking for at least a year. Researchers conducted bronchoscopies at baseline and six months to measure

changes in the Ki-67 labeling index. Treatment with celecoxib reduced this index by 34 percent compared to a 3.8 percent increase with the placebo group. Decreases in this index were also linked with a reduction in lung nodules, a potential precursor to cancer.

Obstetricians/gynecologists rank Pfizer as No. 1 pharmaceutical company: SDI

Tue, 05 Jul 2011 00:00:00 GMT

According to SDI's Pharmaceutical Company Image 2011 study, obstetricians/gynecologists ranked Pfizer No. 1 overall. Forty percent of the 325 participating OB/GYNs reported that Pfizer was one of the three companies they held in highest esteem. In the 2010 study, Pfizer placed second.

Bayer nearly captured the top spot, with 40% of respondents also naming the company; Bayer had just one less mention than Pfizer. In 2010, Bayer ranked fourth, with 30% of OB/GYNs considering it a top company. Merck, last year's leader, dropped to third. In 2011, 38% of OB/GYNs reported that Merck was a top company, down from 43% in 2010.

Warner Chilcott, which ranked fourth, called on OB/GYNs more than any other corporation during the 12 months that ended April 2011, accounting for 13% of sales representative calls to these specialists. Bayer made the second-most calls to OB/GYNs, accounting for almost 12% of the total. Teva, Pfizer, and Merck followed with 7%, 7%, and 5% of OB/GYN sales calls, respectively.

"Bayer's improved standing is impressive, particularly over only 1 year's time," said Jason Fox, associate director of SDI's Syndicated Analytics group. "The company's reps have increased their presence among OB/GYNs and must be making a positive impression." Compared with the previous 12 months, Bayer sales calls to OB/GYNs rose 19% in the year that ended April 2011. Bayer sales representatives were most likely to discuss Beyaz or Natazia - two newer contraceptives - or Yaz during their visits with OB/GYNs. Beyaz was discussed during 30% of Bayer's product details to OB/GYNs, Natazia during 24%, and Yaz during 19%.

As a whole, physicians' perception of the pharmaceutical industry improved in 2011, with 58% reporting a somewhat positive or extremely positive overall impression; up 2 percentage points from 2010. This is the first time since 2004 that the percentage of physicians reporting a positive impression increased.

Pharmaceutical Company Image 2011, a comprehensive analysis of pharmaceutical company and industry image as perceived by key healthcare audiences, surveyed more than 9,800 participants in March and April 2011, including physicians from 27 specialties, nurse practitioners, physician assistants, pharmacists, managed care executives, and consumers, regarding their opinions of the pharmaceutical industry and industry trends.

The 2011 version represents the 12th edition of this landmark study, which enables market researchers and brand management to:

Evaluate a company's image relative to market success and increases in prescribing.
Validate corporate initiatives to promote overall company image.
Understand the importance of company attributes among key customers.
Identify whether direct-to-consumer advertising drives perceptions of pharmaceutical manufacturers.

FDA approves Victrelis for Hepatitis C

Wed, 25 May 2011 00:00:00 GMT

The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.

The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.

When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.

“Victrelis is an important new advance for patients with hepatitis C,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.

Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.

Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).

Victrelis is marketed by Whitehouse Station, N.J.-based Merck.

Pfizer’s Revatio receives European Commission approval for pediatric treatment of pulmonary arterial hypertension

Fri, 06 May 2011 00:00:00 GMT

Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. "Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. "With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition.

This approval is another example of our ongoing commitment to rare diseases." The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class. Estimated change in peak VO2 in evaluable patients receiving any dose of Revatio was 7.71 percent (95 percent confidence interval: -0.19 percent to 15.60 percent. The adverse reaction profile seen in this pediatric study was generally consistent with that in adults with pulmonary arterial hypertension taking Revatio. Most adverse events were of mild to moderate severity and were consistent with the known pharmacology of phosphodiesterase-5 inhibitors, the class of medications to which Revatio belongs.

The most common adverse reactions observed in patients treated with Revatio were vomiting, cough, pyrexia, nausea, lower abdominal pain, upper abdominal pain and photophobia. Pulmonary arterial hypertension is a rare, progressive disease characterized by high blood pressure in the pulmonary arteries, leading to heart failure and premature death. Pulmonary arterial hypertension can occur with no known underlying cause, or it can be found in association with other disorders such as connective tissue disease or congenital heart disease. For pediatric patients, Revatio will be available as an extemporaneously prepared oral suspension compounded from Revatio 20 mg tablets and recommended diluents. Revatio is also available in oral and I.V. formulations for the treatment of adults with pulmonary arterial hypertension.

Revatio was first approved by the European Commission in October 2005 for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Revatio is approved for the treatment of pediatric pulmonary arterial hypertension only in the EU, with applications pending in other countries. Since its initial regulatory approval in 2005, Revatio has been approved and launched in more than 50 countries and has amassed more than 100,000 patient-years of experience.

Flu vaccination lowers kidney transplant recipients' risk of organ loss and death

Fri, 06 May 2011 00:00:00 GMT

Getting vaccinated against the flu lowers kidney transplant recipients' risk of organ loss and death, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The results suggest that concerns about the safety of the influenza vaccine in transplant recipients are unwarranted.

Influenza can cause severe illness and even death in some individuals. Organ transplant recipients and those taking immunosuppressant medications face a particularly high risk of dying after being infected. Protection against the flu is especially important for these patients, but earlier reports have suggested that influenza vaccination might activate an immune response that could trigger rejection of transplanted organs.

Some studies have also suggested that the immunosuppressant medications that transplant recipients take may decrease the effectiveness of the influenza vaccine. To investigate these issues, Frank Hurst, MD (Walter Reed Army Medical Center and F. Edward Hebert School of Medicine) and his colleagues assessed Medicare claims for influenza vaccination and influenza infections in 51,730 adult Medicare patients first transplanted from January 2000 to July 2006 and were followed through October 2006. There were 9,678 (18.7%) patients who were vaccinated against the flu in the first year after transplantation. These individuals were 23% less likely to experience organ loss and 18% less likely to die during the study period than individuals who were not vaccinated.

A total of 310 (0.6%) patients got the flu. They were no more likely to experience organ loss than patients who did not get the flu. These findings do not support withholding immunization on the basis of concerns that the influenza vaccine could negatively affect transplanted organs. The authors noted, however, that no data are currently available to prove that influenza vaccination actually prevents the flu in transplant recipients. Source: Clinical Journal of the American Society Nephrology (CJASN)

FDA panel votes in favour of Sunitib (Sutent) for pancreatic tumors

Wed, 13 Apr 2011 00:00:00 GMT

Pfizer Inc. announced this Tuesday that its oral multi-kinase inhibitor Sutent was determined as having a favourable benefit-risk profile by an oncology advisory committee of the FDA for the treatment of unresectable pancreatic neuroendocrine tumors.

The panel voted 8-2 in favour of Sutent – generically called Sunitib malate. Advanced pancreatic neuroendocrine tumour or NET, is a rare, life-threatening and difficult-to-treat form of cancer that accounts for approximately 22-28 percent of all neuroendocrine tumours. Nearly 90 percent of patients are initially diagnosed with locally advanced or metastatic disease, or cancer that has spread to other organs. An unresectable tumour is one that cannot be removed or resected by surgery. Sutent or sunitinib malate targets vascular endothelial growth factor receptor or VEGFR and platelet-derived growth factor receptor or PDGFR, both of which are expressed by many types of solid tumours. The two targets are involved in tumours acquiring blood vessels, oxygen and nutrients needed for growth.

In a February 2009, independent Data Monitoring Committee for the SUN 1111 trial it was hoped that sunitinib would meet its primary endpoint - progression-free survival. In final results, the drug lived up to its backing, more than doubling median progression-free survival compared with placebo in 171 patients with progressive, well-differentiated pancreatic NET. Further, sunitinib also demonstrated advantages in overall survival, objective response rate and patient reported outcomes. To date, more than 100,000 patients have been treated with Sutent worldwide for gastrointestinal stromal tumours after disease progression, and advanced renal cell carcinoma.

The panel's advice will be considered by the FDA when finalizing Pfizer's supplemental New Drug Application or sNDA for sunitinib for the NET indication. Sunitinib was approved in 2006 in the United States for treating locally advanced or metastatic renal cell carcinoma and for imatinib-refractory or -intolerant gastrointestinal stromal tumour (GIST). It was approved for treating PNET in 2010 in Europe. A decision on approval is expected by the end of 2011, according to a company spokesperson

Astellas' Protopic receives Health Canada approval for prevention of eczema flares

Sun, 27 Feb 2011 00:00:00 GMT

Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a new indication for its topical eczema therapy, Protopic® (tacrolimus ointment 0.03% and 0.1%). The new indication means that tacrolimus ointment can be prescribed for maintenance therapy to prevent flares and prolong flare free intervals in patients with moderate to severe atopic dermatitis (commonly called eczema).

These are individuals who experience a high frequency of flares (≥ 5 times per year). Tacrolimus ointment, a steroid-free topical agent, is a topical calcineurin inhibitor (TCI) also indicated for the intermittent-treatment of moderate to severe atopic dermatitis in non-immunocompromised patients. "We're excited to be able to offer eczema sufferers an effective option to help prevent the chronic recurrence of eczema flares," said Michael Tremblay, President of Astellas Pharma Canada, Inc. "Patients can now enjoy being symptom-free for longer periods, ultimately improving their overall quality of life, which is always our primary objective at Astellas." "This new indication is an important adjunct to our treatment armamentarium because atopic dermatitis is in so many cases a lifelong episodic skin disorder, and an important goal of treatment is to prevent or delay recurrent skin exacerbations," said Dr. Harvey Lui, MD, FRCPC, Professor and Head, Department of Dermatology and Skin Science, Vancouver General Hospital, University of British Columbia. "While patients are typically accustomed to using this topical therapy when they are experiencing an eczema flare, our challenge will be to educate them and their health care providers on the new use of tacrolimus ointment on their clear skin for preventing the flare from coming back."

Centocor files REMICADE for ulcerative colitis in pediatric patients

Thu, 30 Dec 2010 00:00:00 GMT

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. REMICADE was designated orphan drug status by the FDA on November 12, 2003 for the treatment of pediatric UC. REMICADE is currently approved for the treatment of adults with moderately to severely active UC who have not responded adequately to conventional therapy. The sBLA is supported by data from a pivotal Phase 3, randomized, open-label trial that assessed the safety and efficacy of induction and maintenance REMICADE treatment in pediatric patients age six through seventeen who were diagnosed with moderately to severely active UC. Eligible patients had an inadequate response to treatment with conventional treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA) treatments. "Data from the Phase 3 trial support the efficacy of REMICADE in inducing clinical response, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in pediatric patients with ulcerative colitis, an orphan disease that is in need of treatment options," said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc. "We are pleased to work with the FDA as we seek approval of REMICADE for the treatment of this very challenging disease."

Simponi (golimumab) penetrates first line biologic position in RA

Tue, 21 Dec 2010 00:00:00 GMT

In its recently released annual 2010 update, ChartTrends®: Biologics in Rheumatoid Arthritis, BioTrends Research Group, Inc. finds that newer biologic agents such as UCB's Cimzia and Centocor OrthoBiotech's Simponi, although lagging in overall market share, have begun to penetrate the first line biologic position primarily at the expense of Pfizer/Amgen's Enbrel and Abbott's Humira.

In a comparison of rheumatoid arthritis (RA) patients who were switched to a second line agent within the past two years, the study found that there was an increase in the percent of patients switching to an alternative mechanism compared to prior years where switching to a second TNF-alpha agent was more prevalent. Significantly fewer patients were being treated with concomitant DMARDs and steroids compared to the prior year and the study found that more than half of the patients who were placed on steroids at diagnosis were subsequently discontinued.

Those that were not discontinued from steroids had marked reductions in the average daily dose prescribed. Certain co-morbidities such as anemia, obesity and cancer history were significantly more prevalent with specific biologic brands. While efficacy was a leading reason for choosing most biologic brands, Simponi, Cimzia and Humira were also commonly chosen for their convenient dosing regimens. Simponi was associated with the highest percent of use related to patient request. For products in late stage development, rheumatologists reported the highest degree of familiarity with Orencia's subcutaneous formulation but the highest interest in Pfizer's JAK-inhibitor, tasocitinib, with close to 40 percent of the audited patients being considered candidates for this new option when it becomes available. ChartTrends®: Biologics in Rheumatoid Arthritis 2010 is a syndicated study based on 1,051 patients with RA who are currently being treated with biologic agents. The records were submitted by 226 US rheumatologists for patients most recently seen in their offices. Through an in-depth review of de-identified patient chart metrics, details such as product dosing and titration, switching, line of therapy, co-morbidities, concomitant medications and a host of laboratory and demographic variables help define patient types and identify therapy triggers. Included with the report is a patient database for further datamining.

Australia’s federal government will subsidize the cost of Champix (varenicline) to help smokers quit.

Thu, 09 Dec 2010 00:00:00 GMT

Australia’s federal government has announced that it will subsidize the cost of nicotine patches to help smokers quit. The announcement was made by Health Minister Nicola Roxon on Thursday who said that concession card holders would be able to access Nicorette, Nicabate P and Nicotinell under the Pharmaceutical Benefits Scheme (PBS) from February 1, 2011. She said, “Cancer scars the lives of too many Australians and we know that reducing the smoking rate is one of the most effective ways to reduce the rate of death from this terrible disease.” Anti-smoking drug Varenicline (Champix) would also be available for willing quitters.

Anti-smoking group Quit applauded the effort saying that increase in the tobacco tax earlier was a big motivating factor and this move is a vital support to quitters. Spokeswoman Fiona Sharkie said, “These two policies together will really help smokers butt out for good.” Ms Sharkie said the cost of a four-week course of nicotine patches was currently between $100 and $140, and the smallest available pack of patches cost two to three times as much as a pack of cigarettes. But under the new subsidized arrangements, smokers who get a doctor’s prescription for patches can receive a four-week course for approximately $5.40 to $33.30, she added. The Australian Council on Smoking and Health welcomed the move too. President Mike Daube said, “We do know that smokers see the cost of patches as a disincentive to buying them… This gives them a financial boost, it also means that one of the important barriers to quitting is no longer there.” He added, “Smoking costs the economy over $30 billion a year, so the price we pay for subsidising these patches is minimal in comparison with the overall costs of smoking.” The package announced is to cost $340 million.

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

Thu, 02 Dec 2010 00:00:00 GMT

Pfizer Inc. (NYSE: PFE) announced today that the European Commission has approved SUTENT® (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults. Experience with SUTENT as initial treatment is limited in this disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide. Sutent is the first treatment to be approved for patients with pancreatic NET in twenty-five years. The approval is based on results from a randomized, Phase 3 trial that demonstrated SUTENT more than doubled the time period that patients were free from disease progression or death. The progression-free survival (PFS) for SUTENT was 11.4 months vs. 5.5 months for placebo. "This approval represents a significant milestone in the management of pancreatic NET," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "SUTENT has been a standard of care for patients with advanced/metastatic renal cell carcinoma (RCC) and imatinib-refractory gastrointestinal stromal tumor (GIST) for several years, and we are proud that it is now a treatment option for patients in Europe with progressive pancreatic NET." Although rare, the reported incidence of pancreatic NET appears to be rising, accounting for approximately nine percent of neuroendocrine tumors.(5) Current treatment options have limited therapeutic benefit and the prognosis is poor for patients with advanced pancreatic NET.(6) "As the first anti-VEGF therapy to show a substantial clinical benefit in treating progressive pancreatic NET, SUTENT represents a novel therapeutic approach for this difficult-to–treat disease." said Dr. Eric Raymond, principal investigator of the pivotal Phase 3 study that led to the approval of Sutent for pancreatic NET in Europe. "Physicians in Europe will now be able to use a therapy with proven efficacy to treat this disease." Dr. Raymond is professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France. SUTENT is also approved for the treatment of unresectable well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma in the Philippines, Switzerland, Colombia and Korea. In addition, it is under regulatory review for this indication in several other countries.

Pfizer's Sutent stands as first-line setting for treating renal cell carcinoma

Wed, 03 Nov 2010 00:00:00 GMT

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of renal cell carcinoma (RCC), the majority of surveyed European oncologists who favor Pfizer's Sutent indicate that they would switch to an emerging therapy only if it extended progression-free survival (PFS) by at least an additional two to three months, assuming the agent's safety and tolerability profile was comparable to that of Sutent. However, a notable proportion of oncologists would require an improvement of at least six months in PFS over Sutent, suggesting that Sutent—the leading agent in the market—will be difficult to dislodge from its dominant position as the first line agent of choice in this indication.

Pfizer announces approval of Lyrica capsules for peripheral neuropathic pain

Tue, 02 Nov 2010 00:00:00 GMT

Pfizer Inc. announced today that the Japanese Ministry of Health, Labour and Welfare approved Lyrica® (pregabalin) capsules for the treatment of peripheral neuropathic pain. This follows the recent approval in Japan of Lyrica for the treatment of postherpetic neuralgia on April 16, 2010. Lyrica is the first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd.

"Neuropathic pain remains an under-diagnosed condition in many parts of the world, in large part due to low awareness and understanding of the condition and the fact that there are few proven treatment options available," said Steve Romano, M.D., vice president, Medical Affairs Head, Primary Care Business Unit at Pfizer. "This approval reinforces the benefit that Lyrica can bring to appropriate patients suffering from peripheral neuropathic pain."

For the first time, the CDC recommends that everyone, regardless of age or health, get an influenza shot

Fri, 24 Sep 2010 00:00:00 GMT

The New York Times reported, "About 11,500 cases of whooping cough, or pertussis, have been reported nationwide so far this year," and "in California, where the infections are nearing a record high, nine infants have died." Some experts suggest that "some of those children had not received all their shots," although "some of those deaths might have been prevented if more adults, too, had been immunized." Dr. Melinda Wharton, deputy director of the National Center for Immunization and Respiratory Diseases at the CDC, said, "Almost everyone understands how important it is for children to be immunized...but adults need vaccines too." Notably, "this year, for the first time, the CDC recommends that everyone, regardless of age or health, get an influenza shot," which "provides protection against the H1N1 virus and two seasonal viruses."

Flu shot may cut heart attack risk, study finds

Mon, 20 Sep 2010 00:00:00 GMT

A British study suggests getting a seasonal flu shot can not only prevent the flu — it may also prevent heart attacks in some people. Researchers at the University of Lincoln found flu vaccination is associated with a 19 per cent reduction in the rate of first heart attacks. The study also found that getting vaccinated earlier rather than later in the fall further increases the benefits.

Getting inoculated between September and mid-November was associated with a 21 per cent reduction in the heart attack rate, compared to a 12 per cent drop with later vaccination. It’s believed that inflammation caused by influenza may cause plaque inside coronary arteries to break off and cause a heart attack.

The study is published in this week’s issue of the Canadian Medical Association Journal.

NICE improves access to drug treatments for psoriatic arthritis

Thu, 26 Aug 2010 00:00:00 GMT

the National Institute for Health and Clinical Excellence (NICE) has extended the range of drugs that NHS healthcare professionals can prescribe for people who have active and progressive psoriatic arthritis.

In its updated guidance, NICE advises healthcare professionals to prescribe infliximab (Remicade), etanercept (Enbrel) or adalimumab (Humira) if:

The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and
The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying anti-rheumatic drugs (DMARDs), administered either individually or in combination.

The NICE technology appraisal advises healthcare professionals to opt for the least expensive drug first within their healthcare setting, taking into account the associated administration costs, the required dose and its price per dose. This may vary according to individual patients due to differences in administration methods and treatment schedules.

The guidance also recommends that treatment should be discontinued if a person’s disease does not show an adequate response on the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks. Healthcare professionals should also consider continuing treatment if a person’s skin disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks in the absence of an adequate PsARC response. This assessment should be carried out by a dermatologist to determine whether continued treatment is appropriate on the basis of the skin response alone.

Dr Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: "Psoriatic arthritis is a progressive and painful disease, which can significantly affect a person’s ability to work and carry out day-to-day activities. The impact of severe psoriasis on a person’s quality of life is considered to be similar to that of other major medical conditions, like diabetes or heart disease.

"The aim of treatment is to relieve the symptoms, delay the progression of the disease and maintain quality of life for as long as possible. We are confident that etanercept, infliximab and adalimumab can do this for certain patients; and so are pleased that all these drugs can be recommended as options for people who have psoriatic arthritis."

The final guidance replaces and updates two technology appraisals published by NICE in 2006 and 2007.

Researchers identify novel approach to decrease glioblastoma multiforme recurrence

Wed, 25 Aug 2010 00:00:00 GMT

Researchers from the University of Massachusetts Medical School have identified a novel approach of combining chemotherapy with a targeted therapy to decrease the recurrence of glioblastoma multiforme, the most common and aggressive brain tumor.

"Glioblastomas are horrendous tumors, and new therapies are desperately needed," said lead researcher Alonzo H. Ross, Ph.D., professor of biochemistry and molecular pharmacology at the University of Massachusetts Medical School. "We found that this double therapy of combining temozolomide with a Notch inhibitor was highly effective at treating tumor cells in culture and in mice," he added. Results of this study are published in the September issue of Cancer Research, a journal of the American Association for Cancer Research.

Despite treatment with surgery, radiotherapy and chemotherapy, glioblastoma prognosis and survival rates are poor. This may in part be due to the fact that some cells within the tumor - cancer stem cells - are more resistant to these therapies, eventually allowing the tumor to recur, according to Ross. "We're both very successful and unsuccessful with cancer therapy; in most cases we can substantially diminish the tumor mass. The problem is that it comes back with vengeance, and is even more resistant and difficult to treat," he said. Temozolomide is one chemotherapeutic agent that helps patients with glioblastomas live longer; two-year survival rates increase from approximately 10 percent with radiation alone to 25 percent when temozolomide is combined with radiation, according to Ross. Likewise, data have indicated that the Notch signaling pathway is often over-expressed in glioma tissue and tumor cells.

Ross and colleagues evaluated this double-therapy approach of combining temozolomide with a Notch inhibitor in cell culture and in immunodeficient mice to determine if this combination therapy enhances therapy to reduce tumor recurrence. In both models, the researchers saw that the combination of temozolomide with the Notch inhibitor much more effectively reduced tumor growth and recurrence compared to either agent alone. Either drug used individually only transiently slowed tumor growth.

"Temozolomide is a chemotherapy drug of choice for glioblastomas, and the results of our preclinical study represent a potential promising new approach to combat an extremely difficult tumor," Ross said. "The effect of the two together is very dramatic." Patrick M. O'Connor, Ph.D., chief scientific officer of Selexagen Therapeutics and editorial board member for Cancer Research, believes this study provides preclinical proof-of-concept evidence that the Notch pathway confers a survival advantage to glioma cells treated with temozolamide.

"These results help lay the groundwork for future clinical research and are yet another stepping stone towards a future era dominated by 'precision therapeutics' designed to specifically target the underlying molecular drivers of cancer growth and spread," said O'Connor. The researchers are currently investigating the mechanism of action for cell death and hope to move these findings into the clinic.

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Mon, 09 Aug 2010 00:00:00 GMT

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.
The approval of the Prefilled Dual-Chamber Syringe is an important milestone for hemophilia patients due to its innovative, convenient reconstitution system that eliminates the transfer step," said Emil Andrusko, vice president, marketing, Specialty Biologics at Pfizer Inc. "Pfizer is committed to the hemophilia community not only through the development of novel reconstitution systems focusing on convenience, such as the XYNTHA Prefilled Dual-Chamber Syringe, but also through early clinical research of other proteins, including Factor Xa and Factor VIIa."
The first Prefilled Dual-Chamber Syringe will provide 3000 IU of XYNTHA, the highest dose, in a low 4 mL volume. Other dosages of XYNTHA will be available in the Prefilled Dual-Chamber Syringe in 2011. The device is used to deliver XYNTHA by intravenous (IV) infusion after reconstitution of a freeze-dried powder with the diluent (0.9% Sodium Chloride). For the first time, both the XYNTHA powder and the diluent are supplied within the Prefilled Dual-Chamber Syringe.
"For the hemophilia A patient who is always on-the-go, any treatment option that can enhance convenience is critical to the management of his health and lifestyle," said Sue Geraghty, RN, MBA, Nurse Coordinator, University of Colorado School of Medicine Hemophilia and Thrombosis Center. "As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with hemophilia A convenience in reconstituting XYNTHA, potentially saving them both time and effort."
SOURCE Pfizer Inc.

FDA approves Aricept (Donepezil) 23 mg tablet for Alzheimer's disease

Mon, 26 Jul 2010 00:00:00 GMT

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for the treatment of moderate-to-severe Alzheimer's disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available. According to the Alzheimer's Association, approximately 3.6 million Americans age 65 and older have moderate-to-severe AD. “We have a long-standing commitment to the AD community and recognize that there are few treatment options available”

The approval of Aricept 23 mg tablet is based on data from a large head-to-head study of Aricept 23 mg tablet versus Aricept 10 mg tablet in over 1,400 patients with moderate-to-severe AD. Two co-primary endpoints were examined: the Severe Impairment Battery (SIB), a validated clinical instrument that measures cognition, and the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+), another validated clinical instrument that measures global function. Aricept 23 mg tablet demonstrated a statistically significant improvement in cognition, but did not achieve statistically significant improvement in global function, as compared to Aricept 10 mg tablet.

"Slowing the decline of cognitive symptoms is important at all stages of Alzheimer's disease," said Dr. Martin R. Farlow, professor and vice-chairman of research, department of neurology, Indiana University School of Medicine and lead author of the pivotal study publication. "Throughout the course of AD, caregivers are usually the first to notice changes in cognition. It's important for families to talk with their doctor when they notice a worsening in cognitive function in their loved ones to reevaluate therapeutic needs."

Cyclosporine treatment develops higher de novo cancer risk in liver transplant patients: Researchers

Sun, 25 Jul 2010 00:00:00 GMT

Researchers at Erasmus MC University Medical Centre in The Netherlands found that cyclosporine treatment is a significant risk factor for the development of de novo cancer in liver transplant patients. Full details appear in the July issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).
The 1-year survival rate after liver transplantation has dramatically increased in the past three decades to more than 80%. In contrast, there has been little improvement in long-term outcomes. Malignancy is one of the major leading causes of late death after liver transplant and is reported to be directly related to the intensity and the cumulative dose of immunosuppression.
Calcineurin inhibitors (CNI) such as cyclosporine (CsA) or tacrolimus (TAC) are the cornerstone of immunosuppressive treatment after transplantation. Several studies have yielded conflicting results about the incidence of de novo cancer between CsA- based and TAC-based regimens. Elucidating the role of different CNI regimens in the occurrence of de novo cancer after liver transplant was the goal of this study.
SOURCE Liver Transplantation

Gabapentin shows effective in patients with locked-in syndrome, opsoclonus-myoclonus syndrome

Sat, 17 Jul 2010 00:00:00 GMT

For patients with quadriplegia, mutism and lower cranial nerve paralysis (locked-in syndrome), their only means of interacting with others is through vertical gaze and upper eyelid movements, using eye-coded communication strategies.

In the June issue of Mayo Clinic Proceedings, researchers from Italy describe four patients with locked-in syndrome who also had dancing eye syndrome (opsoclonus-myoclonus syndrome). Because these patients' eyes spontaneously and continuously oscillated in a variety of directions beyond their control, they could no longer interact with family members, physicians or other people.

The lead author, Francesca Pistoia, M.D., University of L'Aquila, Italy, reports that a decision was made to treat these patients with daily continuous gabapentin therapy based on a previous successful experience. Gabapentin was started as a single 300 mg dose on the first day followed by 600 milligrams per day in divided doses on the second day. In two of the patients, this dosage reduced ocular symptoms, and communication and quality of life improved. For the other two patients, the dose was further increased, with the best response achieved with a daily 1,200 mg dose.

In all four patients, attempts to stop treatment resulted in recurrence of dancing eye symptoms six hours after the last dose. Thus, gabapentin use was promptly resumed. Researchers found none of the patients experienced adverse effects from the treatment.

In an accompanying editorial, Joseph Sirven, M.D., Mayo Clinic neurologist, discusses the off-label use of gabapentin, which was approved by the U.S. Food and Drug Administration in 1994 for use as an adjunctive medication to control partial seizures. Dr. Sirven writes, "Ironically, despite the fact that the drug was invented and synthesized for its use in seizure prevention, its smallest market today is epilepsy and seizures."

"The study by Pistoia and colleagues has a potential profound impact for treatment of patients with locked-in syndrome and opsoclonus-myoclonus syndrome," writes Dr. Sirven. "Because this neurologic condition is so rare, small observational studies serve as the main source of clinical evidence and could be the cornerstone for clinical practice with no other evidence."

Source: Mayo Clinic

Patients with advanced Parkinson's disease prefer dopamine agonists, shows review

Fri, 09 Jul 2010 00:00:00 GMT

Of the three main types of oral drugs commonly added to levodopa therapy for patients with advanced Parkinson's disease, one might be the most effective, according to a new review.
People with Parkinson's disease often initially experience tremors, stiffness, slowed movement or difficulty with balance and coordination. These symptoms result from the destruction of brain cells that produce dopamine - an important chemical that transmits nerve impulses.
Many people with Parkinson's start treatment by taking levodopa, which the body converts to dopamine. After a time, however, levodopa alone is not always enough.
The three classes of drugs for add-on treatment are dopamine agonists, which stimulate dopamine receptors in the brain, drugs known as COMT inhibitors and MAOB inhibitors, which slow the breakdown of dopamine in the body.
Of these, dopamine agonists might be most effective, according to a new review.
The irony for patients and doctors alike is that while all of the add-on drugs help improve functional motor skills, they simultaneously might increase numerous other side effects such as dyskinesia, dizziness, sleep disturbances, nausea, constipation and even hallucinations.
Although the risk of side effects increased with all three types of add-on drugs, patients were most likely to continue treatment when they were taking dopamine agonists. This class includes medications such as pramipexole (Mirapex), ropinirole (Requip), cabergoline (Dostinex) and bromocriptine (Parlodel).

This review assessed data from 44 randomized trials involving 8,436 participants. The authors caution, however, that the studies compared each class of drugs against placebo, rather than conducting "head-to-head" comparisons of each class against the others.
This leaves open the possibility that the findings arose not from actual differences in the treatments, but rather from other factors such as differences in the types of people included in the various trials. A large trial featuring direct comparisons of the three drug classes currently is underway in the United Kingdom, Clarke said.
Of the drugs in the COMT inhibitor class, the review suggests that tolcapone (Tasmar) is as effective as the dopamine agonists. However, tolcapone has been linked to a few cases of fatal liver toxicity and can now only be prescribed in the United States with intense monitoring.
"Tolcapone is worth using in patients where [the alternative] is not working well, and we mustn't discount it," Clarke said. "This evidence clearly states that."
SOURCE The Cochrane Library

Pfizer's new chewable Lipitor for children receives European Commission approval

Wed, 07 Jul 2010 00:00:00 GMT

Pfizer Inc. (NYSE: PFE) announced it has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.
The Decision to approve the use of atorvastatin in these pediatric patients in Europe is based on the results of a pediatric investigation plan (PIP) filed by Pfizer with the European Medicines Agency (EMA) in November 2009. Investigations into pediatric use are required by recent European pediatric regulations in an effort to encourage pharmaceutical companies to increase understanding of the use of medicines in children. Pfizer hopes to improve treatment options for such pediatric patients, reflecting its ongoing support for patients at risk of cardiovascular disease.
To support the investments necessary to conduct clinical trials in children, the EU created certain incentives, including the availability of a six-month extension to an existing patent extension, also known as a supplementary protection certificate (SPC). As previously announced in November 2009, Pfizer intends to apply for the additional six months of patent protection in European countries where it has an SPC. A country-by-country process will be required to secure this patent term extension.
Based on the results of Pfizer-sponsored trials, in March, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended that a pediatric-appropriate formulation of Lipitor (chewable tablets) be approved for the treatment of hypercholesterolaemia in adolescents and children aged 10 years or older, and the approval of this indication for the currently available presentations of Lipitor (film-coated tablets). The European Commission Decision formalizes these recommendations, which must now be implemented in all EU member states.
As a result of an earlier pediatric clinical development program, Lipitor has been approved for use in children (aged 10 to 17 years) with heterozygous familial hypercholesterolemia in the United States since 2002.
SOURCE Pfizer Inc.

Extended hepatitis C treatment increases sustained virological response after liver transplant

Mon, 03 May 2010 00:00:00 GMT

Extending hepatitis C treatment for liver transplant patients beyond current standards results in high clearance rates of the hepatitis C virus from the blood, and a low relapse rate, according to a study by Henry Ford Hospital.
"We found that patients who achieved a sustained virological response were more likely to have had extended treatment after transplant," says Matthew Moeller, M.D., gastroenterology fellow at Henry Ford Hospital and lead author of the study.
"In the study, we saw a trend toward decreased mortality as sustained virological response was found to be associated with a 100 percent five-year survival rate vs. 86 percent for those without."
Although, statistically insignificant, the trend could show significance with longer follow-up and a larger sample size, explains Dr. Moeller.
Study results will be presented May 2 at the Digestive Diseases Week conference in New Orleans.
The study looked at 241 consecutive liver transplant patients from 1999-2006. Patients were offered treatment if they tested positive for hepatitis C, had recurrent hepatitis C with at least Stage I fibrosis on biopsy, and stable immunosuppression for a minimum of three months. Patients received either non-pegylated interferon tiw or pegylated interferon weekly in combination with ribavirin.
Of the study patients with hepatitis C, 66 were eligible for treatment, and 22 achieved sustained virological response. Only two patients (8 percent) relapsed. This is in contrast to typical relapse rates of 30-35 percent in non-transplant patients treated with standard therapy. Genotype 1 patients failed more than genotype 2 or 3 patients in achieving sustained virological response (27 percent vs. 70 percent).
Dr. Moeller notes that 35 percent of patients who went on to achieve sustained virological response first became virus-negative at or following week 24.
"Our results suggest that even if patients are positive at week 24, there is still a 35 percent chance that they can achieve sustained viral clearance with extended treatment," says Dr. Moeller.
Source: Henry Ford Health System

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Mon, 03 May 2010 00:00:00 GMT

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.
Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Patients with chronic pancreatitis or those who have had their pancreas removed (to manage conditions of the pancreas such as CP, pancreatic cancer or pancreatic tumors) often develop EPI. This insufficiency reduces the production or secretion of enzymes that are necessary to digest nutrients in food and can result in a type of oily diarrhea known as steatorrhea, malabsorption of nutrients, weight loss and even chronic malnutrition if left untreated.
With this FDA approval, CREON is the first medication in its class to have this guidance and information in its prescribing information for use in treating EPI due to CP and pancreatectomy.
"Without proper dosing guidance, some patients have previously attempted to control EPI symptoms by modifying their diets and limiting fat intake," said Orelle Jackson, executive director of the National Pancreas Foundation. "However, this approach has yielded limited treatment success."
The sNDA approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to CP or pancreatectomy. The primary efficacy endpoint was a clinical measurement of how much fat consumed by a patient is absorbed by the body rather than excreted.
"Until now, patients who have had their pancreas removed or those with chronic pancreatitis have too often received inadequate doses of pancreatic enzymes to address their symptoms," said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center. "The availability of new data for CREON is a benefit to prescribers by providing appropriate dosing information that can impact the treatment of these patients."

SOURCE Abbott

First case of treating cystic fibrosis and Crohn's disease with infliximab

Tue, 20 Apr 2010 00:00:00 GMT

Cystic fibrosis (CF) is the most common life-threatening autosomal recessive disease in Caucasian children; it has an incidence of 1 case in every 2500 children born alive. CF involves an anomalous function of the exocrine glands, caused by a mutation of a gene (cystic fibrosis transmembrane conductance regulator, CFTR) located on chromosome 7, which codes for a protein involved in ion transport through the cell membrane. Pulmonary complications are the most common causes of mortal-ity, but the presenting symptoms are very often linked to gastrointestinal and pancreatic biliary diseases. These are mainly caused by the unusual viscosity of the secretions in hollow organs and in the ducts of solid organs. Crohn's dis-ease (CD) is a chronic inflammatory bowel disease which may be localized throughout the gastrointestinal tract. The association between CD and CF is known; there are reports of a prevalence of CD in patients suffering from CF 17 times higher than in controls.
A research article to be published on April 21, 2010 in the World Journal of Gastroenterology addresses this question. A research team led by Professor Gian Luigi de' Angelis, reported the first case of a patient with CF and CD treated with infliximab.
After initiation of infliximab in this patient, there was an improvement of colonic lesions and general condition without any infective complication and particularly without any decline of lung function.
This report confirms the preliminary data regarding the possibility that airway inflammation in CF plays a crucial role in lung damage and that the inflammation is mediated by tumor necrosis factor alpha. Therefore, the use of anti-tumor necrosis factor alpha antibody improved CD and did not generate any complications of lung function, perhaps promoting an anti-inflammatory effect both on colon and lung.
Source: World Journal of Gastroenterology

FDA-approved metformin can prevent tobacco-carcinogen induced lung tumors: Study

Tue, 20 Apr 2010 00:00:00 GMT

Metformin, a mainstay of treatment for patients with type 2 diabetes, may soon play a role in lung cancer prevention if early laboratory research presented here at the AACR 101st Annual Meeting 2010 is confirmed in clinical trials.
Metformin decreases levels of insulin-like growth factor-1 (IGF-1) and circulating insulin, which is important in patients with type 2 diabetes. However, emerging research suggests metformin may inhibit tumor growth as well.
"This well tolerated, FDA-approved diabetes drug was able to prevent tobacco-carcinogen induced lung tumors," said Phillip A. Dennis, M.D., Ph.D., senior investigator in the medical oncology branch of the National Cancer Institute.
For the current study, Dennis and colleagues treated mice with metformin for 13 weeks following exposure to a nicotine-derived nitrosamine (NNK), which is the most prevalent carcinogen in tobacco and a known promoter of lung tumorigenesis.
When given orally, metformin was well tolerated and reduced tumor burden by 40 percent to 50 percent. Dennis said levels of metformin reached in mice are readily achievable in humans.
Dennis and colleagues further evaluated the effects of metformin on a series of biomarkers for lung tumorigenesis and found that it inhibited mammalian target of rapamycin (mTOR), which promotes lung tumor growth, by decreasing levels of circulating insulin and IGF-1. This effect was even more profound when metformin was administered to mice by injection, which reduced lung tumor burden by 72 percent.
SOURCE American Association for Cancer Research

Infliximab-azathioprine combination helps more Crohn's disease patients achieve remission

Thu, 15 Apr 2010 00:00:00 GMT

A study led by Mayo Clinic suggests remission from Crohn's disease (http://www.mayoclinic.org/crohns/) may be more likely if patients get biologic therapy combined with immune-suppressing drugs first instead of immune-suppressing drugs alone. The study, published in the April 15, 2010 issue of the New England Journal of Medicine, found treatment of moderate to severe Crohn's disease with infliximab plus azathioprine allows more patients to achieve remission and mucosal healing than therapy with azathioprine alone.
“These study results are strong enough to change clinical practice”
"Results of this study will provide doctors and their patients with more information on how to use these drugs most appropriately to most effectively treat Crohn's disease," says Dr. Sandborn. "For the first time, we have longer term outcome data on the advantages of combination therapy that will help guide our treatment of patients with Crohn's disease."
Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. One common therapy used to manage the disease is a series of intravenous infusions of infliximab, which blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease. Azathioprine is an orally administered, small molecule immunosuppressive which has a broad immunosuppressive effect.
Each year, physicians at Mayo Clinic's campuses in Arizona, Florida and Minnesota treat approximately 2,000 patients who have Crohn's disease. For more information on the treatment of Crohn's disease at Mayo Clinic click this link: http://www.mayoclinic.org/crohns/.
Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in U.S. News & World Report's Honor Roll of Top Hospitals since the rankings began 20 years ago.
Dr. Sandborn provided consulting services for Centocor Ortho Biotech during the course of this research and received no personal compensation. Mayo Clinic received reimbursement for the services provided by Dr. Sandborn.
Source Mayo Clinic

Bausch + Lomb Introduces New PreserVision(R) Eye Vitamin And Mineral Supplement

Mon, 12 Apr 2010 00:00:00 GMT

Bausch + Lomb announces the U.S. launch of PreserVision® Eye Vitamin and Mineral Supplement AREDS 2 formula. This builds on the original, clinically proven Age-Related Eye Disease Study (AREDS) formula, replacing beta-carotene with lutein (10mg) and zeaxanthin (2mg) and adding omega-3 fatty acids (1000 mg) per daily dosage. The product will be on retail shelves in early May, 2010.
Scientific studies show that the inclusion of high levels of omega-3 fatty acids, lutein and zeaxanthin in the diet supports eye health. Age-related macular degeneration (AMD) is the number one cause of severe vision loss and blindness in the United States for people over the age of 50.
The AREDS2® study, which is currently ongoing and expected to complete in 2013, is sponsored by the National Eye Institute/National Institute of Health and is the second nationwide clinical study to determine whether a combination of vitamins and minerals can further slow the progression of vision loss from AMD. PreserVision AREDS 2 formula is one of many formulas that are being evaluated in this study.
Source
Bausch + Lomb

Pfizer's Neurontin to earn 50% patient share in treatment of postherpetic neuralgia: Survey

Tue, 23 Mar 2010 00:00:00 GMT

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a novel formulation of Pfizer's Neurontin that is dosed once a day would earn a 50 percent patient share in the treatment of postherpetic neuralgia, according to surveyed U.S. neurologists. In Europe, such an agent would earn a patient share of 40 percent, according to surveyed European neurologists. Such a drug would become patient-share leader both in the U.S. and Europe's postherpetic neuralgia market in 2013.
The new report entitled Postherpetic Neuralgia: The Greatest Opportunities Are Improved Safety and Tolerability also finds that interviewed experts' concern regarding the need to manage the pain associated with NeurogesX/Astellas's Qutenza administration prevents the drug from earning Decision Resources' proprietary clinical gold standard status for the treatment of postherpetic neuralgia. Great commercial opportunity exists for Qutenza which, like Endo/Elan/Grunenthal's Lidoderm (the current and future clinical gold standard), offers analgesic efficacy comparable to that of sales-leading Lyrica and is devoid of systemic side effects.
"Although experts recognize the long-term efficacy of a single administration of Qutenza as a significant advantage, they cite the need to manage the transient pain associated with the drug's administration as a significant disadvantage. In the balance of these attributes however, experts consider Qutenza a therapeutic option that compares favorably with Lidoderm," stated Decision Resources Analyst Sami Fam, Ph.D. "We believe Qutenza will have tremendous commercial opportunity should experts' perception of its ease of administration improve once they become familiar with the drug."
SOURCE Decision Resources

2010/025 NICE recommends infliximab and adalimumab for the treatment of severe, active Crohn's disease

Thu, 04 Mar 2010 00:00:00 GMT

In final draft guidance published today (4 March) NICE has recommended infliximab and adalimumab as treatment options for people with severe, active Crohn’s disease whose condition has not responded to conventional therapy, or who are intolerant of or have contraindications to conventional therapy.

Crohn’s disease is a chronic inflammatory condition of unknown cause affecting the gastrointestinal tract (gut). It is estimated that around 60,000 people in the UK have the disease, with approximately 3,000 (5%) having the most severe forms of the condition. The disease causes parts of the gastrointestinal tract to become inflamed, causing diarrhoea, pain in the abdomen, weight loss and tiredness. Ulcers can form in the wall of the gastrointestinal tract and when they heal the scar tissue makes the tract narrower. Sometimes Crohn’s disease causes the formation of abnormal passageways (fistulas) between parts of the intestine, or between the intestine and the skin. It can also affect other parts of the body, such as the eyes or the joints. People with Crohn’s disease can have recurrent attacks - that is, they have times when their disease flares up and in between they have periods of remission.

The draft guidance from NICE recommends infliximab and adalimumab as treatment options for adults with severe, active Crohn’s disease that has not responded to conventional treatment, or who are intolerant of or have contraindications to conventional therapy. Treatment should normally be started with the less expensive drug (taking into account drug administration costs, required dose and product price per dose). Infliximab is also recommended for adults with active, fistulising Crohn’s disease, and for children and young people aged 6-17 years old with severe, active Crohn’s disease.

Propofol is safe for endoscopic procedures with low rate of sedation-related adverse events: Study

Thu, 04 Mar 2010 00:00:00 GMT

Propofol is safe for advanced endoscopic procedures with a low rate of sedation-related adverse events when administered by a trained professional, according to a new study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute.
"This is the first paper to report the frequency of airway modifications (AMs) associated with propofol use in endoscopy. We believe that the need to perform AMs highlights the importance of a trained professional, such as a nurse anesthetist, who is solely responsible for maintenance of sedation and patient monitoring while using propofol," said Sreenivasa S. Jonnalagadda, MD, of the Washington University School of Medicine and lead author of the study. "Perhaps the highest-risk patients should be managed by nurse anesthetists trained in advanced airway interventions, whereas lower-risk patients can be safely managed by professionals with less intensive airway training."
Doctors prospectively studied patients undergoing sedation with propofol for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound and small bowel enteroscopy; a total of 799 patients were enrolled over seven months. Sedative dosing was determined by a certified registered nurse anesthetist with a goal of achieving deep sedation. Sedation-related complications included 154 AMs performed in 115 patients, such as 97 chin lifts, 29 modified face mask ventilations and 28 nasal airways. Additional complications included hypoxemia (deficient oxygenation of the blood, 12.8 percent); hypotension requiring vaso-pressors (abnormally low blood pressure, 0.5 percent); and early procedure termination (0.6 percent); these rates are comparable to other published data.
Elevated BMI, male sex and American Society of Anesthesiologist class greater than or equal to three were found to be independent predictors of patients who would be at the highest risk for needing AMs.
"Future studies are likely to identify additional clinical predictors, which may impact the choice of sedatives and level of airway training required to safely administer propofol," added Dr. Jonnalagadda. "While propofol is undoubtedly an attractive sedative for endoscopic procedures, there continues to be debate regarding its safe use by non-anesthesiologists. Newer technologies such as computer-assisted personalized sedation are likely to standardize the use of propofol by non-anesthesiologists in endoscopy."
Propofol is an effective sedative in advanced endoscopy. However, the incidence of sedation-related complications is unclear. Initially approved for the induction and maintenance of anesthesia, propofol has become an increasingly popular sedative for endoscopic procedures due to its rapid onset of action (30 to 45 seconds) and short duration of effect.
Source: American Gastroenterological Association

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Fri, 05 Feb 2010 00:00:00 GMT

Solvay Pharmaceuticals, Inc. announced today that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.
In this clinical study, children aged 7-11 years with EPI due to CF experienced an improved coefficient of fat absorption (CFA) during treatment with CREON® compared to treatment with placebo. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The mean CFA was greater during treatment with CREON® (82.8%) compared to treatment with placebo (47.4%), which resulted in a significant difference of 35.4% (p < 0.001).
Results were similar for a secondary outcome measure of the study, the coefficient of nitrogen absorption (CNA). CNA was used as a measure to evaluate the absorption of proteins. CNA is calculated based on the amount of nitrogen intake and nitrogen excretion. The mean CNA was greater during treatment with CREON® (80.3%) compared to treatment with placebo (45.0%), which resulted in a significant difference of 35.3% (p < 0.001).
The safety and efficacy of PERTs with different formulations of pancrelipase consisting of the same active ingredient as CREON® (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis have been described in the medical literature. There is a history of using different formulations of CREON® to treat pediatric patients with EPI due to CF, which has demonstrated efficacy and safety in those patients through years of clinical experience.
SOURCE Solvay Pharmaceuticals, Inc.

UCLA Study Shows Metformin Is Safe For Patients With Advanced Heart Failure And Diabetes Mellitus

Sat, 09 Jan 2010 00:00:00 GMT

A new study has shown that metformin, a drug often used in the treatment of diabetes mellitus, is safe for use in treating patients who have both diabetes and advanced heart failure. The study was published in the Journal of Cardiac Failure by researchers at the David Geffen School of Medicine at UCLA and is now online here.
"There may be over two million individuals with heart failure and type II diabetes mellitus in the U. S. alone, so this important finding will have fairly broad impact," said Dr. Tamara Horwich, senior author of the study and an assistant professor of medicine in the division of cardiology at the David Geffen School of Medicine at UCLA.
Previous studies have shown that diabetes increases not only the risk of developing heart failure, but also the risk of death among heart failure patients. This is due in large part to the fact that diabetes, because it increases the amounts of sugar and fat circulating in the bloodstream, accelerates the onset of coronary atherosclerosis. This hardening and thickening of blood vessels is the hallmark of atherosclerotic heart disease, the most common cause of death in the country. The optimal treatment for high glucose and fat blood levels among heart failure patients has not been demonstrated.
"many physicians have been reluctant to use metformin and other similar medications to treat this patient group. However, our analysis shows that using metformin to treat diabetes in patients with advanced, systolic heart failure is not only safe, but may also play a role in improving outcomes compared to conventional diabetes care."
Source:
Rachel Champeau
University of California - Los Angeles

BioVectra signs agreements with Sandoz to commercialize and market Docetaxel

Wed, 06 Jan 2010 00:00:00 GMT

BioVectra Inc. announced today it has signed agreements with Sandoz Inc. of Princeton, New Jersey, for Sandoz to commercialize and market the Abbreviated New Drug Application (ANDA) for Docetaxel for injection, the generic version of Taxotere®, developed by BioVectra.
“The Sandoz team is well-positioned to maximize the opportunity for both companies. We look forward to a successful commercial program and providing an important generic alternative to the market.”
The company has reached commercial marketing and supply agreements with Sandoz Inc (a division of Novartis) to extend specific marketing rights within the U.S. for the drug to Sandoz, and BioVectra believes this is the first filing of a substantially complete ANDA containing a Paragraph IV certification for the product. Under the provisions of the Hatch-Waxman Act, it is expected that 180 days of sole marketing exclusivity will be awarded, once final approval is obtained. The filing of the ANDA took place in June, 2009.
Docetaxel for Injection (Taxotere®) is a clinically well-established anti-mitotic chemotherapy medication, used mainly for the treatment of breast, ovarian, neck, and non-small cell lung cancers. Worldwide sales of Taxotere®, the Sanofi-Aventis brand of the drug, exceed 3 billion USD annually.
http://www.biovectra.com/

Anti-inflammatory prescription drug reduces the risk of common skin cancer in humans

Tue, 05 Jan 2010 00:00:00 GMT

A widely-available anti-inflammatory prescription drug can reduce the risk of a common skin cancer in humans, according to a researcher at Stanford's School of Medicine. Although oral administration of the drug, celecoxib, is associated with an increased risk of heart attack and stroke in some people, it's possible that topical application could have a safer, protective effect for people prone to developing the cancers, called basal cell carcinomas, the researcher believes.
"Basal cell carcinomas are the most common human cancer in the United States," said Jean Tang, MD, PhD, assistant professor of dermatology, "and their incidence is increasing steadily. This work identifies a possible way to prevent them." She and her colleagues dovetailed studies in mice with a randomized, double-blinded clinical trial in humans to reach their conclusions.
Celecoxib is thought to work to prevent or slow cancer growth by interfering with the action of an enzyme called Cox-2, which causes tissue inflammation. Celecoxib has both pain-killing and anti-inflammatory properties. Chronic inflammation has long been associated with the development of many types of cancer, and celecoxib has been shown in clinical trials to reduce the incidence of colon cancer in people with a genetic predisposition to the disease.
Source: Stanford University Medical Center

Pfizer's Revatio solution for injection receives European Commission approval

Mon, 04 Jan 2010 00:00:00 GMT

Pfizer Inc. announced today that the European Commission has approved Revatio^® (sildenafil) solution for injection for patients who are currently prescribed oral Revatio and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable.
“Now with the approval of Revatio solution for injection, we have an option to bridge interruptions in treatment of adult patients who may be temporarily unable to take this important therapy in tablet form.”
Revatio is the only phosphodiesterase 5 (PDE5) inhibitor with both oral and I.V. formulations approved in the European Union for the treatment of PAH.
Pulmonary arterial hypertension is a rare, progressive disease that affects an estimated 100,000 men and women worldwide. This incurable disease is characterized by continuous high blood pressure in the pulmonary arteries, leading to heart failure and premature death. Pulmonary arterial hypertension can occur with no known underlying cause, or it can be found in association with other disorders such as connective tissue disease.
For some patients, continued oral medication may not be an option for a period of time. While oral treatment can often be re-introduced at a later stage, the ability to maintain treatment during periods when the patient is unable to take or tolerate an oral formulation is important to preserving health in patients with PAH. Revatio solution for injection is for adult patients with PAH who are stable on Revatio tablets but who are temporarily unable to take oral medication and for whom the physician considers continuity of treatment to be in the patients’ best interest.
“The approval of Revatio solution for injection is a clear demonstration of Pfizer’s commitment to developing treatments addressing the unmet needs of patients with pulmonary arterial hypertension,” said Cara Cassino, M.D., vice president of Pulmonary Vascular Disease, Clinical Development and Medical Affairs, Pfizer. “This important milestone highlights the Specialty Care Business Units dedication to advance treatments for serious and life-threatening conditions such as pulmonary vascular disease.”

Source Pfizer Inc.

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

Wed, 02 Dec 2009 00:00:00 GMT

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC^™Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.
The NDA was submitted by Schering-Plough under the terms of a license agreement for OTC proton pump inhibitor (PPI) products using Santarus’ proprietary technology. Upon approval of ZEGERID OTC, Santarus earned a $20 million milestone and may be entitled to receive up to an additional $37.5 million in sales milestones. Santarus will also be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold by Schering-Plough HealthCare Products under the license agreement. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.
“We are pleased that Schering-Plough HealthCare Products has achieved this significant regulatory milestone for ZEGERID OTC and we look forward to seeing the product on retail store shelves across the United States in the first half of 2010,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We believe the consumer advertising and publicity associated with the launch of ZEGERID OTC will increase awareness of the ZEGERID^® brand.”

Pfizer, Protalix team up to develop and market plant-based enzyme for Gaucher’s disease treatment

Tue, 01 Dec 2009 00:00:00 GMT

Pfizer (NYSE: PFE) and Protalix (NYSE-Amex: PLX) today announced that they have entered into an agreement to develop and commercialize taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) in development for the potential treatment of Gaucher’s disease.
Under the terms of the agreement, Pfizer will receive exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive commercialization rights in Israel. Taliglucerase alfa is the first enzyme replacement therapy derived from a proprietary plant cell-based expression platform using genetically engineered carrot cells.
With the successful completion of Phase III clinical studies, Protalix is preparing to complete a rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The FDA has granted Orphan Drug designation and Fast Track status, facilitating the development and expediting the review of drugs to treat rare conditions or diseases, as well as an Emergency Use Authorization. The FDA has also requested, and subsequently approved, an Expanded Access Program (EAP) treatment protocol. Taliglucerase alfa is currently being provided to Gaucher’s patients in the U.S. under the EAP protocol, as well as to patients in the European Union under a compassionate use protocol.
Source: Pfizer

Carvedilol in combination with ACE inhibitors may benefit cardiac patients

Sat, 21 Nov 2009 00:00:00 GMT

In a new study, researchers report that a class of heart medications called beta-blockers can have a helpful, or harmful, effect on the heart, depending on their molecular activity.
The study, which appears in the journal Circulation Research, found that beta-blockers that target both the alpha- and beta-receptors on the heart muscle offer the most benefit to cardiac patients, while those that target only the beta-receptors can actually undermine the structure and function of the heart.
Circulation Research is published by the American Heart Association.
Heart disease is the leading cause of death in the United States. Patients with heart disease usually have higher levels of catecholamines - hormones that activate the beta-adrenergic receptors to stimulate cardiac muscle contraction. In this process, the heart initially grows to become a more efficient pump. Unfortunately, the researchers found, this growth also predisposes the heart to eventual failure.
Traditionally, beta-blockers targeting the beta-adrenergic receptors have been utilized as a long-term therapy for heart failure.
The new study unveiled an elegant intracellular signaling system in which beta-receptor activation modulates alpha-adrenergic signaling. It showed that blocking the beta-receptor alone promotes cardiac remodeling via growth of cardiac fibroblasts induced by alpha-adrenergic receptor signaling. The growth of fibroblasts in the heart further damages the integrity and function of the heart.
This observation suggests that the use of carvedilol in combination with inhibitors of angiotensin-converting enzyme (ACE inhibitors) may be of the greatest benefit to cardiac patients, and has significant clinical implications on which beta-blockers patients should take.
Source: University of Illinois at Urbana-Champaign

FDA approves Pfizer's Geodon Capsules for the adjunctive maintenance treatment of bipolar disorder

Sat, 21 Nov 2009 00:00:00 GMT

Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon^® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.
“The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control," said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.
Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.
Source Pfizer Inc.

Pfizer’s Revatio Injection receives FDA approval

Fri, 20 Nov 2009 00:00:00 GMT

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio^® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.
Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication.
Pulmonary arterial hypertension is a rare, progressive disease that affects an estimated 100,000 men and women worldwide. This incurable disease is characterized by continuous high blood pressure in the pulmonary arteries, often leading to heart failure and premature death. Pulmonary arterial hypertension can occur with no known underlying cause, or it can occur in association with other disorders.
Due to the chronic nature of pulmonary arterial hypertension, maintaining medical therapy can delay clinical worsening for patients.However, in some cases, oral medication may not be an option for a period of time. While oral treatment can often be re-introduced at a later stage, the ability to maintain treatment during periods when the patient is unable to take an oral formulation is important to preserving health in patients with pulmonary arterial hypertension.
“The approval of Revatio Injection is a clear demonstration of Pfizer’s commitment to developing treatments addressing the unmet needs of patients with pulmonary arterial hypertension,” said Dr. Cara Cassino, vice president of pulmonary vascular disease, clinical development and medical affairs, Pfizer. “This important milestone highlights the Specialty Care business unit’s dedication to advancing treatments for serious and life-threatening conditions such as pulmonary vascular disease.”
Source Pfizer Inc

CHANTIX/CHAMPIX raises hope for quitting smoking

Thu, 05 Nov 2009 00:00:00 GMT

New study results showed that 42.3 percent of smokers with mild-to-moderate chronic obstructive pulmonary disease (COPD) who took CHANTIX/CHAMPIX^® (varenicline) were able to quit smoking and remain abstinent during the last four weeks of treatment (weeks 9-12) compared with 8.8 percent of those given placebo (p<0.0001). These findings were presented by investigators at CHEST 2009, the 75^th annual international scientific assembly of the American College of Chest Physicians (ACCP).
“Quitting smoking is of paramount importance for all smokers, particularly those with a smoking-related illness, such as COPD,” said Dr. Donald Tashkin, study investigator, emeritus professor of medicine at University of California, Los Angeles. “This study shows that varenicline is an effective means of smoking cessation for a highly nicotine-dependent, difficult-to-treat group of patients. The safety profile of varenicline in this study was consistent with its pre-approval clinical trials.”
Up to one-half of all people who smoke may eventually develop COPD, a serious illness that includes both chronic bronchitis and emphysema. More than 12 million people in the United States are diagnosed with COPD, and 80 to 90 percent of them are smokers. Further, approximately 24 million U.S. adults have evidence of impaired lung function, suggesting that many people who smoke may have COPD and not yet realize it.Worldwide, COPD currently affects 210 million people and is expected to become the world’s third leading cause of death by 2030.
“We at Pfizer want to help people quit smoking,” said Dr. Briggs W. Morrison, senior vice president, Primary Care Medicines Development Group at Pfizer. “We sponsored this trial to offer healthcare providers additional information on smokers who are at risk for or diagnosed with COPD, who might especially benefit from quitting. This is just one of several planned and ongoing studies of varenicline that we hope will enhance the medical community’s understanding of this important medicine.”
According to international treatment guidelines from the Global Initiative for Chronic Obstructive Lung Disease (GOLD), quitting smoking is the single most effective--and cost-effective--intervention to prevent COPD and slow its progression. The guidelines recommend that all smokers, including those who may be at risk for COPD and those who already have the disease, be offered the most intensive smoking cessation intervention feasible, such as medication and support.

SOURCE Pfizer Inc

Pregabalin reduces abdominal pain and improves sleep in women with adhesions

Tue, 27 Oct 2009 00:00:00 GMT

Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.
Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.
"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.
Study results will be presented Oct. 26 at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.
"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.
The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.
The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.
The primary objective was to demonstrate a significant reduction in pain scores.
The pain score result from the blinded phase indicated that the amount of decrease was significantly greater in the drug group (p-value = 0.024) compared with those on placebo, while the pain score resulted from the open label setting indicated that the amount of decrease was significantly greater in the placebo group (p-value = 0.043). This would be expected since those on active drug continued to take active drug and patients who had received the look-alike placebo received the active drug only during this phase of the study.
Source: Henry Ford Health System

Schering-Plough Highlights Boceprevir, Narlaprevir (SCH 900518) And PEGINTRON(R) Data At The American Association For The Study Of Liver Diseases

Fri, 16 Oct 2009 00:00:00 GMT

Schering-Plough (NYSE: SGP) announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3. Researchers will present sustained virologic response (SVR) data on boceprevir triple combination therapy in treatment-naive HCV genotype 1 patients who had a null response to peginterferon and ribavirin (defined as <1 log decrease in HCV viral load) in the 4-week lead-in arms of the Phase II SPRINT-1 study. Patients with null response to peginterferon and ribavirin are considered to be among the most difficult to treat successfully.
Several presentations will report results with PEGINTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy, an approved treatment regimen for chronic hepatitis C. These include a late-breaker oral presentation on a genome-wide analysis of patients from the IDEAL study that identified the first genetic marker that may predict a patient's response to peginterferon and ribavirin combination therapy for hepatitis C. Peginterferon and ribavirin are expected to remain the backbone of HCV treatment regimens for the next several years. Schering-Plough is in the process of analyzing options for the development of a genetic test based on this marker and for making it widely accessible to providers, patients and diagnostic companies for the advancement of science and for helping physicians and patients make more informed treatment decisions.
Source: Schering-Plough

Results Published In Journal Of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption

Sat, 10 Oct 2009 00:00:00 GMT

Solvay Pharmaceuticals, Inc. announced that Phase III data published in the Journal of Cystic Fibrosis showed that CREON® (pancrelipase) Delayed-Release Capsules, the most prescribed pancreatic enzyme replacement therapy (PERT) in the United States, significantly improves a key measure of fat absorption in patients with CF who suffer from exocrine pancreatic insufficiency (EPI). EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food and, if untreated, can lead to poor growth, poor weight gain and failure to thrive in children with CF.
According to the study results, patients with CF and confirmed EPI had an improved coefficient of fat absorption (CFA) during treatment with CREON® compared to treatment with placebo. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is a way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The trial reached statistical significance on its primary endpoint, which was CFA.
Source: Solvay Pharmaceuticals, Inc.

FDA Advisory Committee approves Peginterferon alfa-2b for treating metastatic melanoma

Tue, 06 Oct 2009 00:00:00 GMT

Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the FDA Oncologic Drug Advisory Committee voted in favor of recommending approval of PEGINTRON® as a treatment in addition to surgery in patients with metastatic melanoma. The product is currently being marketed, manufactured and developed by Schering-Plough. PEGINTRON (Peginterferon alfa-2b) is currently indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease and previously untreated with interferon alpha. PEGINTRON is also indicated for use in combination with REBETOL® (ribavirin) for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease. PEGINTRON is one of several products which utilize Enzon’s PEGylation technology, including CIMZIA®, Macugen®, and Pegasys®.
“We congratulate Schering-Plough for this great achievement. PEGINTRON provides effective treatment to hepatitis C patients and we are pleased Schering-Plough continues to explore its use in additional areas,” said Jeffrey H. Buchalter, Enzon's president and chief executive officer.
http://www.enzon.com/

Mayo study reveals infliximab reduces the need for colectomy

Thu, 01 Oct 2009 00:00:00 GMT

A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology.
Ulcerative colitis, an inflammatory bowel disease (IBD) that causes chronic inflammation of the colon, is characterized by abdominal pain and diarrhea. Like Crohn's disease, another common IBD, ulcerative colitis can be debilitating and often lead to colectomy or surgical removal of the colon.
"Our purpose in this study was to see if the use of infliximab for ulcerative colitis would reduce the need for surgery," says William Sandborn, M.D., a Mayo Clinic gastroenterologist and lead author of the study. "We found that treatment with infliximab reduced the need for colectomy by 41 percent compared to patients treated with placebo."
In this multi-center, international study, 728 patients received placebo or infliximab (5 or 10 mg/kg) for 46 weeks and were monitored for hospitalization or surgical outcomes. Eighty-seven percent (630 of 728) had complete follow-up for the endpoint of whether or not they had colectomy, while the remaining 13 percent (98 of 728) of patients had follow-up for less then a year, with a median follow-up of 6.2 months in these patients. The research showed that treatment with infliximab at 0, 2 and 6 and then every 8 weeks reduced the incidence of colectomy through 54 weeks by 41 percent in outpatients with moderately-to-severe active ulcerative colitis.
The cumulative incidence of colectomy through 54 weeks was 10% for infliximab and 17% for placebo>
"One of the most feared outcomes for ulcerative colitis patients is surgical removal of the colon," says Dr. Sandborn. "Our research hopes to provide other treatment solutions for patients beyond surgery."
Previous research has shown that infliximab therapy induced clinical remission and bowel healing for colitis patients. This new research provides more information and options for patients struggling with this difficult disease, explains Dr. Sandborn.
Infliximab is an artificial antibody that works by blocking tumour necrosis factor alpha (TNFα). TNFα is a chemical messenger and a key part of the immune reaction. Infliximab blocks the action of TNFα by preventing it from binding to its receptor in the cell.
Source: Mayo Clinic

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Sat, 19 Sep 2009 00:00:00 GMT

Pfizer Oncology will present data from across its portfolio, including results from long-term follow-up of Aromasin^®(exemestane tablets) in a study of early breast cancer, updated study results from a Phase 3 study of Sutent^®(sunitinib malate) in pancreatic neuroendocrine tumors (NET), and early-stage research of investigational agents PF-02341066 and figitumumab (CP-751,871) in patients with non-small cell lung cancer (NSCLC). These data, and over a dozen additional abstracts covering Pfizer agents, will be presented at the ECCO 15/ESMO 34 bi-annual meeting in Berlin, Germany from September 20 to September 24.
“Pfizer is conducting research to identify clinical benefits for targeted patient populations with investigational compounds like cMET/ALK inhibitor, while continuing to study drugs like Aromasin through their entire life cycle to ensure we provide maximum support and information to patients and healthcare providers about our cancer products,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit.
https://www.pfizeroncology.com/sites/Pop/pages/index.aspx

Schering-Plough Reports Long-Term Vicriviroc Data From Phase II Open-Label Extension Study In Treatment-Experienced HIV-Infected Patients

Tue, 15 Sep 2009 00:00:00 GMT

Schering-Plough Corporation (NYSE: SGP) reported long-term data with vicriviroc, its investigational CCR5 receptor antagonist, from an ongoing, open-label extension of the Phase II VICTOR-E1 study in treatment-experienced HIV-infected patients. The results showed that vicriviroc plus optimized background therapy achieved durable virologic suppression and increased CD4 cell counts, and was generally well tolerated over two years of therapy. These 96-week results were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).(1)
Vicriviroc, currently in Phase III development, is an extracellular inhibitor of HIV infection. Unlike other classes of HIV drugs that work to inhibit viral replication within human CD4 cells, most of which are part of the immune system, vicriviroc is a member of the CCR5 receptor antagonist class, and is designed to prevent the virus from infecting healthy CD4 cells by blocking its predominant entry route, the CCR5 co-receptor. Approximately 50-60 percent of treatment-experienced patients have virus that uses the CCR5 co-receptor.(2)
Source: Schering-Plough Corporation

Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections

Mon, 14 Sep 2009 00:00:00 GMT

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.
VIBATIV will be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009. Theravance will collaborate with Astellas in marketing in the United States for the first three years following approval.
VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV is indicated for the treatment of adult patients with cSSSI caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
Source
Theravance, Inc.

Schering-Plough launches CLARITIN 12-Hour for non-drowsy relief from allergy symptoms

Tue, 01 Sep 2009 00:00:00 GMT

Schering-Plough Corporation (NYSE: SGP) today announced the introduction of CLARITIN 12-Hour, the only 12-hour allergy medicine found in the allergy aisle. New CLARITIN 12-Hour lasts all day and provides effective, non-drowsy relief from the worst indoor and outdoor allergy symptoms. The product is available for adults and children ages six and up.
"New CLARITIN 12-Hour offers the proven allergy relief people have relied on for years, with the added flexibility for people who want more control of their treatment," said Dr. John O'Mullane, group vice president, research and development, Schering-Plough Consumer Health Care. "Allergy sufferers can choose to treat their allergy symptoms for 12 or 24 hours depending on their individual needs."
Until now, sufferers shopping the allergy aisle had to choose between 4-6 hour products, which could cause drowsiness, or products offering 24 hours of relief. However, according to a recent study, 34% of allergy sufferers want something in between (1). Today, those sufferers finally have a non-drowsy option that meets their needs.
CLARITIN 12-Hour, which comes in convenient RediTabs(R) tablets, is great for people on the go since they dissolve quickly without water (2). It is also convenient for moms looking to give their kids all day allergy relief, while allowing the flexibility to re-dose at night, if needed.Like other CLARITIN products, NEW CLARITIN 12-Hour is available without a prescription and treats allergy symptoms such as itchy, watery eyes, sneezing, and runny nose without drowsiness. CLARITIN 12-Hour can be found in most food, drug or mass retailers.
http://www.schering-plough.com

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) Updated

Mon, 31 Aug 2009 00:00:00 GMT

FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm

European Medicines Agency validates Schering-Plough's MAA for a fixed-dose combination of mometasone furoate and formoterol fumarate

Thu, 27 Aug 2009 00:00:00 GMT

Schering-Plough Corporation, (NYSE: SGP), today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older.
Mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, ASMANEX(R), with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, FORADIL(R), administered via a single metered-dose inhaler.

About the Investigational Mometasone Furoate and Formoterol Fumarate CombinationSchering-Plough has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol fumarate fixed-dose combination. In the United States, a New Drug Application (NDA) for the fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older is currently under review by the U.S. Food and Drug Administration (FDA). Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and chronic obstructive pulmonary disease (COPD) medications, in terms of dollar sales.(1) The fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma in patients younger than 12 years of age and for use in COPD is currently in Phase III development.

Source: http://www.schering-plough.com

Schering-Plough Announces FDA Approval Of SAPHRIS(R) (asenapine) For Acute Treatment Of Schizophrenia In Adults And Manic Or Mixed Episodes Of Bipolar

Sat, 15 Aug 2009 00:00:00 GMT

Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) has approved SAPHRIS((R)) (asenapine) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. SAPHRIS can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously.
"We are very pleased with the U.S. approval of SAPHRIS, which represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "SAPHRIS is an important addition to Schering-Plough's product portfolio, and represents the first U.S. approval resulting from the Organon/Schering-Plough combination."
SAPHRIS is expected to be available in the U.S. during the fourth quarter of 2009.
Schizophrenia affects about 24 million people worldwide, including two million Americans, and bipolar I disorder affects about 1 percent of adults, including 10 million Americans.
The FDA approval of SAPHRIS is based on a New Drug Application (NDA) that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The SAPHRIS filing was supported by safety data in 4,500 people, with some patients treated for more than two years. The approval is based on acute schizophrenia trials in which SAPHRIS (5 mg twice daily) demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which SAPHRIS (10 mg twice daily) demonstrated statistically significant reduction of bipolar mania symptoms versus placebo.
Source: Schering-Plough

Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix For Injection) For Advanced Prostate Cancer Treatment

Wed, 05 Aug 2009 00:00:00 GMT

Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the trade name FIRMAGON(R) (degarelix for injection) for its prostate cancer treatment previously marketed under the generic name degarelix. FIRMAGON is a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. Since initial market introduction under the generic name degarelix, FIRMAGON has been used by more than 3,000 patients to fight their prostate cancer.
"This treatment was in development by Ferring Pharmaceuticals in the U.S. and Europe for more than a decade," said Wayne Anderson, President and CEO of Ferring Pharmaceuticals Inc., USA. "We launched degarelix prior to receiving approval for its brand name in order to bring the medical community an effective alternative in the treatment of advanced prostate cancer without delay. We plan to continue our research in the area of urology and we expect to introduce additional treatment advances in the future."
FIRMAGON provides fast, long-term suppression of testosterone, a hormone that stimulates prostate cancer growth.(1-3) Phase III pivotal studies showed that FIRMAGON is as effective as leuprolide (Lupron Depot(R))* in reducing and sustaining castrate levels of testosterone.(1,2) Suppression of testosterone to castrate levels occurred significantly faster in patients receiving FIRMAGON than in those receiving leuprolide.(1,2) At Day 3 of treatment, the FIRMAGON group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels, a statistically significant result. FIRMAGON was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the FIRMAGON patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.
In addition, prostate-specific antigen (PSA) levels were lowered by 64 percent two weeks after administration of FIRMAGON, 85 percent after one month, 95 percent after three months, and remained suppressed throughout the one year of treatment.(1,2) These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

Tighter Controls On Cold And Flu Remedies Help Fight Against Class A Drugs

Sun, 02 Aug 2009 00:00:00 GMT

Cold and flu remedies containing pseudoephedrine and ephedrine will remain as pharmacy (P) medicines after tighter controls were found to minimise the misuse of these ingredients in the illegal manufacture of methylamphetamine (crystal meth).
Following a public consultation in 2007, the Commission on Human Medicines (CHM) advised that these medicines should only be available in the pharmacy in reduced pack sizes and with tighter controls on their sale.
The CHM advised these changes were to be introduced with the view to reclassifying them to prescription only (POM) status in 2009, unless the risk of misuse was contained.
A Medicines and Healthcare products Regulatory Agency (MHRA) review on the impact of the tighter controls revealed no new reports of the misuse of these drugs in the past year. Pharmacies have also seen a 25 per cent drop in the number of pseudoephedrine tablets or capsules being sold.
Notes
1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

2. The CHM is a statutory body under the Medicines Act, with a duty to advise ministers on matters relating to human medicines. Commission on Human Medicines

3. Methylamphetamine was rescheduled to a Class A drug on 18 January 2007 under the Misuse of Drugs Act 1971. Please refer to the Home Office for queries about methylamphetamine (crystal meth). Home Office (external link)

4. In April 2008, following the CHM advice and public consultation, the legislation was amended to replace large packs of pseudoephedrine and ephedrine with smaller packs of 720mg (the equivalent of 12 tablets/capsules of 60mg pseudoephedrine or 24 tablets or capsules of 30mg). Additionally, a limit of one pack per customer per sales was introduced.

5. Other initiatives included a requirement for dedicated training for all pharmacy staff.

6. The monthly MHRA Drug Safety Update was launched in August 2007. It provides the latest official safety news about medicines to healthcare professionals. Drug Safety Update

7. An online system at http://www.yellowcard.gov.uk makes it quicker and easier to report suspected side effects of medicines to the MHRA.

Source
MHRA

Pfizer And Medivation Initiate Phase 3 Trial Of Dimebon In Patients With Huntington Disease

Sat, 01 Aug 2009 00:00:00 GMT

Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease. The companies also announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to dimebon for the treatment of Huntington disease.

"Based on the promising results of our Phase 2 trial of dimebon in Huntington disease, we are pleased to advance dimebon into late-stage clinical development," said Lynn Seely, M.D., chief medical officer for Medivation. "Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition."

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually, such as Huntington disease, which affects 30,000 individuals in the United States, with another 150,000 at risk. Orphan drug designation entitles Pfizer and Medivation to a seven-year period of marketing exclusivity in the United States for dimebon if it is approved by the FDA for the treatment of Huntington disease. It also enables the companies to apply for research funding, tax credits for certain research expenses, and a waiver from the FDA's application user fee.

Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
Source: Pfizer

96-Week MERIT ES Analysis Shows Efficacy Of Pfizer's HIV/AIDS Treatment Celsentri/Selzentry (Maraviroc) In Treatment-Naïve HIV Patients

Sat, 25 Jul 2009 00:00:00 GMT

At 96-week follow up, data from the MERIT ES analysis show that treatment-naïve HIV patients taking Celsentri/Selzentry (maraviroc), in combination with Combivir® (zidovudine/lamivudine) experienced comparable virologic suppression to undetectable levels and significantly greater increases in CD4 T-cell count through 96-weeks, compared to patients taking efavirenz in combination with zidovudine/ lamivudine. The data also show the favorable tolerability of Celsentri/Selzentry, which was associated with fewer discontinuations due to adverse events.1

The 96-week results from MERIT ES were presented today at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town, South Africa. MERIT ES is an analysis of the data from the MERIT (Maraviroc versus Efavirenz Regimens as Initial Therapy) study following retesting of screening samples using the enhanced sensitivity Trofile™ assay - therefore representing a subset of the MERIT primary analysis population. This enhanced sensitivity test was not available at the time of the MERIT study and is the only version of Trofile currently available.

Results from the MERIT ES population show that, at 96 weeks, a similar number of patients taking Celsentri/Selzentry achieved undetectable viral load compared to those taking efavirenz (<50 copies/mL = 58.5 percent and 62.4 percent, respectively). Comparable results were seen based on a Time to Loss of Virologic Response* (TLOVR) analysis (<50 copies/mL = 60.5 percent on Celsentri/Selzentry versus 60.7 percent on efavirenz). Results also show that, at the end of almost two years, a similar number of patients taking Celsentri/Selzentry remained on therapy compared to those taking efavirenz (66.9 percent and 66.0 percent, respectively).

SAPHRIS(R) (asenapine) Meets Primary Endpoint In Long-Term Extension Study In Patients With Predominant, Persistent Negative Symptoms Of Schizophrenia

Sat, 25 Jul 2009 00:00:00 GMT

Schering-Plough Corporation (NYSE: SGP) announced that its investigational agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia.

Negative symptoms of schizophrenia include apathy, lack of emotion and poor social functioning, among others. In the study, these symptoms were assessed using the validated 16-item Negative Symptom Assessment scale (NSA-16).
"These symptoms are among the most difficult to treat in the schizophrenia spectrum," said Armin Szegedi, M.D., Ph.D., vice president, global clinical research, central nervous system, Schering-Plough Research Institute. "Few studies with the antipsychotics currently available on the market have been designed specifically to evaluate long-term effects on predominant, persistent negative symptoms. The results from this large clinical study program will provide new insights into potential treatment of these symptoms."

In the study, SAPHRIS was significantly more effective than olanzapine in the reduction of negative symptoms as measured by change from baseline to Day 365 in the NSA-16 total score, the primary endpoint of the study. By using a mixed model for repeated measures (MMRM), least square mean changes in the NSA-16 total score were -15.8 for SAPHRIS vs. -11.0 for olanzapine (P=0.015). Full results of the trial, including efficacy, safety and tolerability data, will be submitted for presentation at a medical meeting at a later date.

These results follow those of a previously reported clinical trial in this patient population using the same study design and protocol in which both asenapine and olanzapine reduced negative symptoms after one year of treatment, but the difference between the two was not statistically significant.(1)

Additionally, a preliminary pooled analysis of the combined data for these two identically designed studies showed a statistically significant treatment effect in favor of asenapine after one year of treatment.

These large Phase III studies were conducted following a previous Phase II study where favorable data on negative symptoms were observed for asenapine.
Source: Schering-Plough Corporation

Immunotherapy Linked To Lower Risk Of Alzheimer's Disease

Tue, 21 Jul 2009 00:00:00 GMT

IVIg treatments, the addition of good antibodies into the blood stream, may hold promise for lowering the risk of Alzheimer's disease and other similar brain disorders, according to research published in the July 21, 2009, print issue of Neurology®, the medical journal of the American Academy of Neurology.

"In our study, we looked at the association of the use of intravenous immunoglobulin (IVIg) with the occurrence of Alzheimer's disease. IVIg has been used safely for more than 20 years to treat other diseases but is thought to have an indirect effect on Alzheimer's disease by targeting beta-amyloid, or plaques in the brain," said Howard Fillit, MD, with the Mount Sinai School of Medicine in New York.

For the study, researchers analyzed the medical records of 847 people given at least one treatment of IVIg over four years and 84,700 who were not given IVIg treatment. Participants were treated for immune deficiencies, leukemia or other types of cancer, anemia and other diseases. The records were pulled from a database of 20 million patients age 65 or older developed by SDI Health. Scientists made sure the groups were similar in their risk factors for Alzheimer's disease.

The study found that people who received IVIg for other conditions had a 42-percent lower risk of developing Alzheimer's disease over four years compared to those who did not receive IVIg. Only 2.8 percent of those treated with IVIg developed Alzheimer's disease compared with 4.8 percent of those not treated with immune-based therapy.
Source: American Academy of Neurology (AAN)

Pfizer Receives Approval From European Commission For Pending Acquisition Of Wyeth

Mon, 20 Jul 2009 00:00:00 GMT

Pfizer Inc (NYSE: PFE) announced that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company's pending acquisition of Wyeth. The Commission's decision includes Pfizer's commitment to divest certain animal health assets in the EU.

"We are pleased to have achieved another significant milestone for the pending acquisition with the EC's approval of the transaction," said Amy Schulman, senior vice president and general counsel of Pfizer.

In addition, Pfizer announced that China's Ministry of Commerce has extended its review of Pfizer's regulatory submission beyond the initial thirty-day period. The completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, governmental and regulatory approvals in certain other jurisdictions, and approval by the stockholders of Wyeth.

Ms. Schulman stated, "We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close at the end of the third quarter or during the fourth quarter of 2009."

Source
Pfizer Inc.

Phase II Study Of Sunitinib In Men With Advanced Prostate Cancer

Sun, 12 Jul 2009 00:00:00 GMT

In the Annals of Oncology, Dr. Dror Michaelson and associates reported Phase II data on the efficacy and safety of the tyrosine kinase inhibitor sunitinib in patients with castration-resistant prostate cancer (CRPC). Sunitinib inhibits vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF), both elevated in prostate cancer (CaP).

Two groups of patients were studied; group A, which was chemotherapy naïve and group B, which had failed docetaxel. The primary endpoint was PSA decline >50% from baseline. Secondary endpoints included objective response rate, safety, tolerability and serum biomarkers. Treatment was in 6-week cycles, consisting of 50mg daily for 4 weeks followed by 2 weeks off. Concurrent treatment with bisphosphonates was permitted.

Seventeen men in each group had data available for analysis. Only one patient in group A, and one patient in group B demonstrated a >50% PSA decline. Fourteen of 34 men had some PSA decline and 8 men (34%) had a >30% PSA decline. At 12-week analysis it was noted that radiographic improvements were present in some patients who nevertheless had increasing PSA levels. Based upon not having 2 or more PSA response criteria met, the study enrollment was not continued. Adverse events were primarily grade 1 or 2 and included nausea, fatigue, anorexia, taste disturbance, vomiting, diarrhea and skin rash. Regarding biomarkers, sVEGFR2, PDGFaa, and leptin all decreased but did not correlate with PSA.

Dror Michaelson M, Regan MM, Oh WK, Kaufman DS, Olivier K, Michaelson SZ, Spicer B, Gurski C, Kantoff PW, Smith MR
Ann Oncol. 2009 May;20(5):913-20.
doi:10.1093/annonc/mdp111

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

Thu, 09 Jul 2009 00:00:00 GMT

KENILWORTH, N.J., July 9, 2009 /PRNewswire-FirstCall via COMTEX/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for ASMANEX TWISTHALER (mometasone furoate dry powder inhaler) for the treatment of bronchial asthma in adults.(1)

"We are pleased to announce the approval of the ASMANEX TWISTHALER in Japan," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "ASMANEX was discovered and developed by Schering-Plough Research Institute and offers physicians and patients in Japan an effective inhaled corticosteroid to treat bronchial asthma in an innovative dry powder inhaler device," Koestler added. "Schering-Plough K.K. has received eight total new chemical entity approvals in Japan during the past two years, underscoring Schering-Plough's commitment to improving health and well being for patients in Japan."
SOURCE Schering-Plough Corporation

FDA Adds Strong Warnings To Anti-Smoking Drug Labels

Fri, 03 Jul 2009 00:00:00 GMT

"The Food and Drug Administration announced (Wednesday) that it is requiring the smoking-cessation drugs Chantix and Zyban to carry the strongest type of safety warning possible to alert patients that the medications can cause serious mental health problems, including depression and suicide," the Washington Post reports (Stein, 7/1).

"About 100 suicides in patients taking Chantix have been reported to the FDA since 2006, said Curtis Rosebraugh, an FDA official. By comparison, there have been 14 reports of suicide in patients taking Zyban," the Wall Street Journal reports. "Both companies say there is no evidence that their drugs actually cause suicides or mood swings. And along with the FDA, they both note that smokers trying to quit often experience depression, anger and other psychiatric side effects." The FDA also stressed that the warnings aren't meant to advise smokers not to use the drugs (Mundy and Favole, 7/2).

Sutent Significantly Improved Progression-Free Survival For Patients With Advanced Pancreatic Islet Cell Tumours

Wed, 01 Jul 2009 00:00:00 GMT

Pfizer announced preliminary results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic islet cell tumours, also known as pancreatic neuroendocrine tumours, which is a different type of cancer than the more common pancreatic adenocarcinoma. Study findings demonstrated that median progression-free survival (PFS) was 11.1 months in patients treated with Sutent compared to 5.5 months in patients treated with placebo. Researchers today presented these data at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The independent Data Monitoring Committee (DMC) recommended halting the trial earlier this year because Sutent showed significant benefit and the study had met its primary endpoint. Full analysis of the data is ongoing.

"In this study, Sutent demonstrated an impressive improvement in progression-free survival for patients with pancreatic islet cell tumours," said Dr. Eric Raymond, MD, PhD, Professor of Medical Oncology and Head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, and lead investigator on this sunitinib Phase 3 study. "This is encouraging news for patients, especially given that there are limited treatment options for this type of advanced cancer."

Phase 3 Trial Results

This international, Phase 3 trial compared sunitinib to placebo in patients with progressive, well-differentiated, malignant pancreatic islet cell tumours who had progressed in the last 12 months. Patients were randomized to either the sunitinib (n=75) (37.5 mg/day, continuous daily dosing) plus best supportive care arm or the placebo plus best supportive care arm (n=79).

Results showed that median PFS was 11.1 months in patients treated with sunitinib compared to 5.5 months in patients treated in the placebo arm (Hazard ratio 0.397, p<0.001).

Adverse events were similar to those observed in other sunitinib studies. The most commonly reported grade 3-4 adverse events in the sunitinib arm were neutropenia (12.3 percent), hypertension (8.8 percent), abdominal pain (7 percent), diarrhea (7 percent), hypoglycemia (7 percent) and hand-foot syndrome (7 percent).

This trial was initiated based on the results of an earlier Phase 2 trial of 107 patients published in the Journal of Clinical Oncology (July 2008). A 16.7 percent overall objective response rate (RECIST) and 56.1 percent stable disease rate (SD ≥6 months) was seen in the 66 patients with advanced pancreatic islet cell tumours treated with sunitinib.

"The observation of substantial improvement in progression free survival in Sutent-treated patients was the basis for the independent Data Monitoring Committee's recommendation to halt accrual to the study early," said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "This is welcome news as there is currently no standard of care for patients with pancreatic islet cell tumours who progress on prior therapy."

About Pancreatic Islet Cell Tumours

In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell tumours are rare, indolent tumours of the endocrine pancreas with an incidence of two to four people per million annually worldwide.

Pancreatic islet cell tumours include insulinomas, glucagonomas and gastrinomas. Current treatment options are limited.

IFX Anti-TNF Therapy Associated With Clinical Benefit Over 5 Years In Patients With Active AS

Mon, 15 Jun 2009 00:00:00 GMT

After five years of receiving infliximab (IFX) anti-TNF therapy, 61.8% of patients with ankylosing spondylitis (AS) showed substantial clinical benefit (ASAS40, ASsessment in AS, 40-response) and 27.6% achieved ASAS partial remission.

Moreover, at five years, 78.4% of AS patients had no arthritis and 84.9% had no enthesitis (inflammation at the junction between tendon and bone). Over this period, patients continued to show a sustained high response rate, low disease activity, good functional state and low creactive protein (CRP, a marker for inflammation) levels, according to the results of a new openlabel follow-up study presented today at EULAR 2009, the Annual Congress of the European League Against Rheumatism in Copenhagen, Denmark.

AS is the most frequent chronic inflammatory rheumatic disease that characteristically affects the axial skeleton, entheses (sites where ligaments and tendons attach to bone) and peripheral joints. In consequence, new bone formation may result - eventually leading to ankylosis (fusion of vertebral bodies). Typical symptoms of AS include inflammatory back pain and spinal stiffness.

Dr Frank Heldmann, Centre of Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany, the coordinator of the study, said: "Until now, our knowledge on the long-term efficacy of anti-TNF therapy in AS has remained rather limited, but the EASIC study group has significantly contributed to furthering this. Since anti-TNF agents are a relatively new treatment option for patients with AS, and can be required for long periods of time, there is strong need to know about their long-term efficacy and safety. The data show that infliximab therapy was associated with sustained efficacy and favourable attrition rates (less than 10% per year for any reason over 5 years). Thus, our study confirms the role of infliximab as an effective and overall well tolerated treatment optoion in the management of patients with this chronic condition."

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Tue, 02 Jun 2009 00:00:00 GMT

Schering-Plough Corporation has announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

The MAA for Sycrest includes data from the asenapine clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.

"We highlighted asenapine as one of the Five Stars in our late-stage research and development pipeline at our R&D Update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009," noted Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "I am pleased that we met this important milestone for asenapine within the first half of 2009."

In the United States, a New Drug Application (NDA) for asenapine, under the brand name SAPHRIS, is currently under review by the U.S. Food and Drug Administration (FDA) for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

http://www.schering-plough.com/

Bausch & Lomb Receives FDA Approval Of Besivance(TM), New Topical Ophthalmic Antibacterial For The Treatment Of Bacterial Conjunctivitis ('Pink Eye')

Sat, 30 May 2009 00:00:00 GMT

Bausch & Lomb, a world leader in eye health, announced that the U.S. Food and Drug Administration (FDA) approved Besivance(TM) (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye." Besivance(TM) is a new topical ophthalmic antibacterial, administered via sterile ophthalmic drops, that treats a wide range of eye pathogens including those that most commonly cause bacterial conjunctivitis.(4) Bacterial conjunctivitis is one of the most common ocular conditions worldwide.(2)

In December 2008, an FDA Advisory Committee voted unanimously to recommend approval of Besivance.

Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use. It offers broad-spectrum antibacterial activity, including activity against the strains that are the most common causes of bacterial conjunctivitis.(3)

"Topical ophthalmic besifloxacin offers physicians the opportunity to provide patients with an anti-infective that treats a broad range of bacterial ocular pathogens," said Marguerite McDonald, MD, FACS, Clinical Professor of Ophthalmology at NYU School of Medicine, New York, New York.

The FDA approval of Besivance was based on a series of eight clinical trials. These studies were designed to test the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics with the topical antibacterial. Its efficacy was evaluated in three multi-center, randomized, double-masked trials involving nearly 2,400 patients with a clinical diagnosis of bacterial conjunctivitis. In clinical trials, investigators found that Besivance treatment resulted in a greater proportion of patients experiencing clinical resolution and microbial eradication, when compared to its vehicle.(4)

"Today's FDA approval of Besivance provides patients with an advanced therapy that can eradicate bacterial conjunctivitis at its source both safely and effectively," said Flemming Ornskov, M.D., M.P.H., corporate vice president and global president, Pharmaceuticals, Bausch & Lomb. "At Bausch & Lomb we are committed to developing innovative eye health products that help enhance patients' overall quality of life, and we are pleased to offer the medical community a new treatment option for this exceedingly common condition."

Besivance will be available by prescription in U.S. pharmacies in the second quarter of 2009. Besivance will be promoted by both the Bausch & Lomb and Pfizer, Inc. sales forces.

Alzheimer's Society Comment On New Data Observing The Cost Effectiveness Of Aricept (donepezil)

Tue, 26 May 2009 00:00:00 GMT

New research presented at the annual meeting of ISPOR suggests that prescribing Aricept on diagnosis of either mild or moderate Alzheimer's disease would save the NHS money.

The National Institute for Health and Clinical Excellence (NICE) currently recommends that Aricept is not prescribed to people in the mild stages of Alzheimer's disease. This study, sponsored by Eisai, takes into account factors not considered by NICE, including cost of caregiver time. It suggests that savings to the NHS and society would be £7,100 per patient over a ten-year period if people with dementia are prescribed Aricept earlier.

A review of the NICE guidance is anticipated later this year.

'Alzheimer's Society has consistently stated that NICE's decision to deny people with dementia access to the only drugs for their condition is unethical and is based on flawed calculations. It disregards the difficulties associated with getting an accurate assessment in the early and middle stages and does not take into account factors such as the benefits treatments bring to carers.

This industry-funded research has examined the cost efficiency of prescribing one of these drugs in the early stages. It uses a complex financial model that considers a wider range of factors and concludes that prescribing this treatment would save NHS money.

NICE must tackle the flaws in its calculations to ensure people with dementia can get access to effective treatments. Alzheimer's Society hopes to see this addresses in the forthcoming review of the NICE guidance.'

Dr Susanne Sorensen
Head of Research
Alzheimer's Society

Full reference

Getslos, Blume, Ishak and Maclaine, Cost-effectiveness Study in Patients with Mild to Moderately Severe Alzheimer's Disease: Projected Benefits of Donepezil in the UK

Source
Alzheimer's Society

CREON(R) (Pancrelipase) Delayed-Release Capsules First And Only Pancreatic Enzyme Product To Receive FDA Approval Under New Guidelines

Sat, 02 May 2009 00:00:00 GMT

Solvay Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CREON(R) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. CREON(R) is the first and only pancreatic enzyme product (PEP) to receive FDA approval under new guidelines for the class.

"Left untreated, EPI causes maldigestion, malabsorption and malnutrition and can ultimately be life-threatening," said Virginia Stallings, M.D., Director, Nutrition Center at the Children's Hospital of Philadelphia, PA and Professor of Pediatrics, University of Pennsylvania School of Medicine. "The goals of treating EPI are to optimize digestion and absorption of food and nutrients, improve outcomes for patients and prevent malnutrition and growth faltering in children and weight loss in adults. Pancreatic enzymes serve as an important component in the effective management of EPI throughout a patient's lifetime."

The efficacy of FDA-approved CREON(R) was demonstrated in a randomized, double-blind, placebo-controlled crossover study which enrolled 32 patients with CF. The primary efficacy endpoint was the coefficient of fat absorption (CFA), which measures the percentage of fat absorption relative to dietary fat intake. CREON(R) produced significantly greater mean CFA values compared to placebo in this study. The mean CFA during treatment with CREON(R) was 89% versus 49% during treatment with placebo, representing a mean difference in CFA of 41%. CREON(R) showed statistically-significant increases in CFA for both adults (age >18 years) and adolescents (age 12-18 years). There was no relevant difference in the magnitude of response between the age groups. The incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON(R) or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache and weight decreased.

"As the first and only product in the pancreatic enzyme class to be FDA-approved under the new guidelines, CREON(R) helps meet a critical need for thousands of patients with EPI," said Dr. Stephen Hill, President, Solvay Pharmaceuticals, Inc. "For more than 20 years, Solvay Pharmaceuticals has been committed to the pancreatic enzyme market in the United States and is proud to bring FDA-approved CREON(R) to patients suffering from EPI."

Lyrica Significantly Reduced Pain and Improved Other Symptoms of Post-Traumatic Peripheral Nerve Pain, New Data Show

Thu, 30 Apr 2009 00:00:00 GMT

Patients suffering from post-traumatic peripheral nerve pain treated with Lyrica® (pregabalin) capsules CV experienced significantly reduced pain compared to those taking placebo, according to new data presented today at the American Academy of Neurology annual meeting. The data also showed that patients treated with Lyrica reported less pain interference with sleep and were significantly more likely to report feeling better overall at the end of the study compared with placebo.

Post-traumatic peripheral nerve pain is a difficult to treat condition that occurs after nerve damage due to trauma from accidental injury or surgery. It can be a chronic condition, affecting the injured area with pain persisting long after the initial injury has healed. Traumatic injury causing long-lasting changes to the peripheral nervous system – the communications network that transmits information to and from the central nervous system (the brain and spinal cord) and every other part of the body – is believed to be the cause of this persistent pain.Post-traumatic peripheral nerve pain can have a wide array of symptoms, including numbness, tingling and prickling sensations, sensitivity to touch or more extreme symptoms including burning pain.

“The findings of the study are good news for the many patients who suffer from this painful and debilitating condition,” said Robert van Seventer, MD, Chair of the Department of Anesthesiology and Director of Amphia Pain Clinic and Research Centre, Amphia Hospital, the Netherlands. “Post-traumatic peripheral neuropathic pain has historically been a challenging condition to treat so this data demonstrating the ability of pregabalin to provide relief for patients is encouraging.”

The study found patients treated with Lyrica experienced significantly reduced pain compared to those taking placebo. At the end of the study, patients receiving Lyrica had, on average, a pain score that was 0.62 points lower on an 11-point scale compared to placebo.Patients receiving Lyrica reported less pain interference with sleep compared to placebo. At the end of the study, patients receiving Lyrica had an average self-reported weekly pain-related sleep interference score of 2.73 (from a baseline of 4.1) on an 11-point scale measuring how much pain had interfered with sleep during the past 24 hours, compared to 4.13 for placebo (from a baseline of 4.8).Additionally, at the end of the study, significantly more patients receiving Lyrica (64 percent) reported feeling “improved” compared to placebo (41 percent).
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1016273&newsId=20090429006303&newsLang=en

FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis

Sat, 25 Apr 2009 00:00:00 GMT

The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion. “Today’s approval provides another treatment option for patients with these three debilitating disorders,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."
Simponi is injected under the skin. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Like other TNF- α blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks. The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.

NICE recommends sunitinib for the first-line treatment of renal cancer

Wed, 25 Mar 2009 00:00:00 GMT

The National Institute for Health and Clinical Excellence (NICE) has today (25 March 2009) issued final guidance recommending the use of sunitinib as a first-line treatment option for people with advanced and/or metastatic renal cell carcinoma who are suitable for immunotherapy and who are well enough to tolerate the treatment.
http://www.nice.org.uk/newsevents/pressreleases/press_releases.jsp?domedia=1&mid=393316B7-19B9-E0B5-D43DD78AEA4EF847

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

Thu, 12 Mar 2009 00:00:00 GMT

KENILWORTH, N.J., March 12 /PRNewswire-FirstCall/ -- Results of a Schering-Plough Corporation (NYSE: SGP) Phase II trial of SCH 530348, a novel oral thrombin receptor antagonist (TRA), were published today in The Lancet and demonstrated that the investigational antiplatelet compound met its primary endpoints of safety and tolerability. TRA showed no increase in major and minor Thrombolysis in Myocardial Infarction (TIMI)-scale bleeding when given with current standard antiplatelet therapy (aspirin and clopidogrel) for patients undergoing percutaneous coronary intervention (PCI), commonly known as balloon angioplasty with stenting.

"The results of this study are encouraging as they support the viability of TRA as a potential new antiplatelet therapy option," said Richard Becker, MD, director of the Duke Cardiovascular Thrombosis Center and lead author of the study. "TRA appears to work in a novel way that is complementary to current antiplatelet therapies," he further commented.

Another important result from the Thrombin Receptor Antagonist Percutaneous Coronary Intervention (TRA-PCI) trial was the rate of thrombin-receptor agonist peptide (TRAP)-induced platelet aggregation inhibition, a secondary endpoint. Thrombin is the most potent platelet activator, which leads to platelet aggregation and the development of blood clots. In the study, TRA showed a much higher TRAP-induced platelet aggregation inhibition compared to standard of care alone in both loading and maintenance doses.

"In this study, TRA, when given with aspirin and clopidogrel, was able to inhibit the aggregation of platelets even when exposed to a very potent stimulant (TRAP-thrombin receptor agonist peptide)," said Enrico Veltri, M.D., group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "These data, along with subsequent data from Phase II acute coronary syndromes (ACS) and stroke studies conducted in Japan, suggest that TRA is a novel medication that targets a pathway to platelet aggregation not addressed by existing medications."

The 1,030-patient TRA-PCI trial was designed to evaluate the safety and tolerability of TRA in patients undergoing PCI. A secondary objective was to assess whether patients treated with the compound in addition to standard-of-care therapies had fewer cardiovascular events such as heart attack, need for urgent coronary revascularization, or death at 60 days compared to patients treated with the standard of care alone. While not powered to establish efficacy, the study did report a non-statistically significant 46 percent reduction in cardiovascular events at the highest TRA dose tested compared to standard of care alone. Preliminary results were presented in March 2007 at the American College of Cardiology/i2 Summit in New Orleans by David J. Moliterno, M.D., Chief of Cardiovascular Medicine, University of Kentucky College of Medicine, and Medical Director of the Linda and Jack Gill Heart Institute, on behalf of the TRA-PCI investigators.
Orginal Link

European Commission and US FDA approve intravenous formulation of temozolomide (Temodal)

Thu, 05 Mar 2009 00:00:00 GMT

Schering-Plough Corporation has announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug.

Temozolomide is marketed as Temodal in the EU and as Temodar in the US. The EU Commission Decision was based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in November 2008. On January 22, 2009, the Commission approved a sachet packaging presentation for Temodal Capsules. This new presentation provides greater patient convenience and flexibility. On February 17, 2009, the Commission approved an IV formulation of Temodal. On February 27, 2009, Schering-Plough received approval from the US FDA for the Temodar IV formulation.

Temodal is a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy. In the US, Temodar is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

"Temodar is a well recognized, effective treatment for patients with newly diagnosed GBM. The newly approved IV formulation of Temodar provides patients with an important alternative method of administration, and the European Temodal sachet presentation offers flexibility and a convenient alternative form of packaging," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "These two new options recognize Schering-Plough's commitment to providing effective treatments in a variety of presentations for specific patient needs and patient convenience."

New Australian Guidelines for the Treatment of Inhibitors in Haemophilia A and Haemophilia B

Wed, 03 Dec 2008 00:00:00 GMT

This document is a general guide to appropriate practice, to be followed subject
to the clinician’s judgment and the patient’s preference in each individual case.
The guidelines are designed to provide information to assist decision-making
and were reviewed in 2008. These guidelines will be reviewed in 2011.

http://www.ahcdo.org.au/publications/list/asset_id/13/cid/1/parent/0/t/publications/title/Guidelines%20for%20the%20Treatment%20of%20Inhibitors%20in%20Haemophilia%20A%20and%20Haemophilia%20B