The Burrill Report


Pfizer and Medivation’s investigational drug dimebon proved no better than a placebo in achieving statistical significance for either of two co-primary efficacy endpoints in a late stage trial in patients with Huntington’s disease. The endpoints were the Mini-Mental State Examination, which measures cognition, or the Clinician's Interview-Based Impression of Change, plus caregiver input, which measures global function. Medivation said it would discontinue development of dimebon in Huntington’s disease as a result. Although dimebon has already failed in one late stage trial for Alzheimer’s disease, Medivation will continue a remaining late stage trial in that indication for which it expects to report top-line data in the first half of 2012.

Hopes for Teva Pharmacuetical’s experimental multiple sclerosis pill laquinimod were dimmed after a results from a pivotal trial showed it reduced the disease’s relapse rate less than hoped, reported Reuters. Teva announced a 23 percent annualized relapse rate over a placebo, less than the hoped for 25 percent. Teva is up against Novartis’ recently approved Gilenya, which showed a 54 percent reduction in relapse rates. In a second measure, disability progression, laquinimod compared favorably with Gilenya as measured by the expanded disability status scale which, at 36 percent, was ahead of Gilenya. Dan Bar-Zohar, Teva's global medical director, told Reuters he was “very happy” with the overall results.

Canadian researchers have found a link between Roche’s diet drug Xenical (orlistat) and an increase in kidney injuries, reports Reuters Health. The new study is based on 953 new users of orlistat and is published in the Archives of Internal Medicine. In an overview of Ontario’s healthcare databases, researchers found that 0.5 percent of new orlistat users were hospitalized for kidney problems in the year before starting on the drug. Over the next year, that number jumped to 2 percent. In an email, Researcher Matthew Weir said that the study should be interpreted cautiously because it is just observational and doesn’t prove causality. The study comes after U.S. health officials warned last year of rare cases of liver damage in people using Xenical or GlaxoSmithKline’s Alli, an over-the-counter version. Orlistat, the active ingredient, inhibits gut absorption of fat. A few days later, GSK announced that it plans to sell Alli along with several other over-the-counter brands. Although once seen as a potential blockbuster, sales of Alli never grew as expected.

European regulators are recommending changes to the product label on GlaxoSmithKline’s pandemic flu vaccine Pandemrix in an effort to draw attention to a potential risk of narcolepsy in children or adolescents associated with the vaccine, Reuters reports. The EU decision is based on preliminary results of studies from Finland, Sweden, and France that suggest a possible link. A final regulatory decision is pending a review expected to conclude in July. GSK believes further information is needed on the causal relationship between Pandemrix and narcopolepsy before coming to any conclusion. Although not administered in the United States, more than 31 million doses of Pandemrix were given to people in 47 countries. GSK said it had been notified of 247 cases of narcolepsy in those vaccinated as of April 5, according to Reuters.

Medical device maker ReGen Biologics filed voluntary petitions for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware, reports MassDevice. The bankruptcy petition includes ReGen’s subsidiary RBio but not its Swiss subsidiary ReGen Biologics AG. ReGen has had an ongoing battle with the U.S. Food and Drug Administration over its Menaflex device, a bio-absorbable mesh knee implant designed to encourage regrowth of damaged knee cartilage. The FDA rescinded ReGen’s 2008 510(k) clearance last week until it can meet the FDA’s standards for safety and effectiveness. ReGen CEO Gerald Bisbee says the company has spent $30 million to meet FDA requirements and feels the FDA’s rescission is unfair, according to MassDevice.

The Justice Department has sentenced W. Scott Harkonen, former CEO of Intermune, to six months of home confinement and fined him $20,000 for his role in disseminating misleading information about the drug Actimmune for the treatment of lung disease, reports Bloomberg. He was convicted of wire fraud in September 2009 for issuing a deceptive press release in 2002 to boost sales of Actimmune, which said the drug reduced deaths by 70 percent in patients with mild to moderate idiopathic pulmonary fibrosis, a fatal lung disease—a false and misleading statement. Although approved to treat rare bone and immune disorders, Actimmune was not approved for idiopathic pulmonary fibrosis. Harkonen plans to appeal his conviction. In 2006 Intermune agreed to pay $36.9 million to settle U.S. claims for illegally marketing the drug for unapproved uses.


April 15, 2011
http://www.burrillreport.com/article-dimebon_fails_in_late_stage_huntingtons_disease_trial.html