The Burrill Report


A U.S. Food and Drug Administration advisory panel has voted against expanding the use of GlaxoSmithKline’s Avodart, its treatment for enlarged prostate, to include reducing the risk of prostate cancer in men at risk for the disease. The panel voted 14 to 2 against. A study found that patients taking Avodart for four years were 23 percent less likely to have detectable prostate cancer, but more men on the drug developed aggressive tumors. An analyst had said, prior to FDA safety concern, that approval of an expansion of indications for Avodart could expand the market for the drug by more than $1 billion a year. The panel also voted 17 to 0 against expanding the label for Merck’s competing drug Proscar because of what it saw as an unfavorable balance of risks and benefits in healthy men at least 55 years old.

Reviewers at the U.S. Food and Drug Administration said Orexigen Therapeutics’ experimental drug to treat obesity helped patients lose weight, but didn't meet all the criteria set by the agency, the Associated Press reported. The review by the agency also raised questions about the effects of the drug on the heart. FDA review of Orexigen's Contrave follows recent rejections by the agency for two other experimental obesity drugs because of safety concerns. The company’s studies showed patients lost an average of 4.2 percent more than patients on placebo, but that was short of the FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.

Merck said it halted studies of single dose of its first-in-class integrase inhibitor to treat HIV-1 infection following initial results from a late-stage study. Isentress is approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults. The study showed that while the treatment regimen that included Isentress once daily enabled more than 80 percent of patients to achieve viral suppression, the once daily dose failed to demonstrate non-inferiority to the treatment regimen that included Isentress twice daily. Merck said that based on the initial results and following the recommendation of an independent Data Monitoring Committee, Merck will end the study. The company is notifying clinical investigators of this decision this week and is recommending that patients enrolled in the once-daily dosing arm of the study be switched to Isentress twice daily, the FDA-approved dose.

Novartis is eliminating 1,400 sales jobs in the United States in the area of general practice drugs as its seeks to ready for the loss of key patents and put a greater emphasis on specialty drugs, Reuters reported. The restructuring is expected to result in a one-time charge of about $85 million. The company, which employs more than 13,000 people in the United States, will lose U.S. patent protection on the $6 billion a year blood pressure drug Diovan in 2012.

An arbitration tribunal in the Netherlands has ruled Johnson & Johnson must pay $130 million to Basilea Pharmaceutica in breach of its license agreement with the company. The payment is compensation for lost payments related to ceftobiprole, including milestones, other damages and interest. The tribunal at the Netherlands Arbitration Institute found Johnson & Johnson’s breach of its agreement with Basilea caused the rejection of ceftobiprole, a novel anti-MRSA broad-spectrum antibiotic, by health authorities.

The U.S. Food and Drug Administration delivered a setback to Merck KGaA in its race to market against Novartis with an oral multiple sclerosis pill when it notified the company it would extend the date for a decision by three months, Bloomberg reported. The FDA is now expected to decide on granting marketing approval for the experimental drug cladribine by the end of February. Novartis won approval for its oral multiple sclerosis drug Gilenya in September.

The U.S. Food and Drug Administration has told GlaxoSmithKline and Valeant Pharmaceuticals International that it would not grant approval to the companies to market ezogabine, an experimental anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures. In a letter to the companies, the FDA cited non-clinical reasons for this action. GSK and Valeant said they believe that these items can be addressed and the two companies are working for a timely response to the FDA as soon as possible in 2011.


December 02, 2010
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