Roche, Biogen Idec Scrap Development of Arthritis Drug: Biotech's LatestMishaps

by: The Burrill Report

Roche (OTCQX:RHHBY) and Biogen Idec (NASDAQ:BIIB) say they will discontinue development of late-stage ocrelizumab in rheumatoid arthritis. The decision follows an analysis of the efficacy and safety results from the program that led the companies to conclude the antibody carried too great a risk to rheumatoid arthritis patients compared to benefits and available treatment options. The ocrelizumab rheumatoid arthritis program included four late-stage studies. Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis in a mid-stage trial. In March, Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab rheumatoid arthritis program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board. The data safety monitoring board concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal that included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration placed the rheumatoid arthritis studies on clinical hold.

Teva Pharmaceutical Industries (NYSE:TEVA) said its experimental to treat Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease, failed in a mid-stage trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in ALS patients. Teva said the trial showed Talampanel was safe for ALS patients, but the study did not meet its primary endpoint.

Forest Laboratories (NYSE:FRX) and Nycomed said that the U.S. Food and Drug Administration informed them that it would not approve their application to begin marketing roflumilast to reduce exacerbations of COPD without additional data and analysis. The companies said the agency did not request additional patient trials. The companies said they are committed to working with the FDA to address the outstanding matters and the companies anticipate a response to the FDA during the third calendar quarter of 2010. Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, roflumilast, a once-a-day oral tablet, will be the first in a new class of treatment for COPD.

Helicos BioSciences (HLCS) said it will eliminate about 40 jobs as part of a restructuring in an effort to cut cost as its shifts its business to focus on diagnostics markets. Approximately half of the Cambridge, Massachusetts-based company's 40 remaining employees are supported by NIH funding on research designed to further improve Helicos' proprietary DNA and RNA single molecule sequencing technology. In its first quarter 2010 regulatory filings, Helicos has said that is was considering alternatives to its existing long-term strategic focus, including the repositioning of the company in the genetic analysis markets. Helicos said that its technology's ability to sequence DNA and RNA directly is well positioned for applications in molecular diagnostics, as it provides a direct path from patient specimen to result, and minimizes sample preparation costs.

A German court has found a key patent on GlaxoSmithKline's (NYSE:GSK) Advair, the biggest-selling asthma drug in Europe's largest market, is invalid, Reuters reported. GSK said it is considering an appeal. The patent, which covers the combination of Advair’s two active ingredients, was set to expire in September 2013. However, generic drugmakers that want to enter the market before 2011 will still need to use an alternative inhalation device because GSK holds patents on the device until 2011.