Roche Terminates HCV Alliance: Biotech's Latest Tribulations

by: The Burrill Report

Ligand Pharmaceuticals (NASDAQ:LGND) said Roche (OTCQX:RHHBY) notified it that it was terminating the collaboration and licensing agreement between Roche and Metabasis Therapeutics (MBRX-OLD), a unit of Ligand. The companies had been developing a hepatitis C treatment since 2008 using Metabasis' liver-targeting technology. Roche paid Ligand a $6.5 million milestone in April when the company advanced its experimental drug to treat HCV into an early-stage clinical trial. The termination of the agreement means Metabasis will get a non-exclusive, worldwide, royalty-bearing license under specific Roche patents to develop, make, and sell related compounds and products. Roche will be prohibited for 10 years following the termination from developing or commercializing related compounds.

The U.S. Food and Drug Administration’s top criminal investigator is retiring in the face of allegations about the alteration of internal agency reports and other misconduct, The Wall Street Journal reported. An anonymous whistleblower in September sent a complaint to Senator Chuck Grassley, R-Iowa. Vermillion and the FDA have not commented on the allegations. A Government Accountability Office report earlier this year requested by Grassley found the FDA’s Office of Criminal Investigations suffered from lax oversight.

San Diego-based Amira Pharmaceuticals has cut half of its workforce in an effort to conserve cash, Xconomy reported. Along with the changes, the privately-held company’s three scientific co-founders have departed. The cuts are focused in the areas of discovery research and administration and leave about 25 people at the firm. The firm is focused on developing small molecule drugs to treat inflammatory diseases.

Cornerstone Therapeutics (NASDAQ:CRTX) said it will voluntarily remove three products containing propoxyphene. The decision comes in response to the U.S. Food and Drug Administration's agreement with Xanodyne Pharmaceuticals regarding the voluntary market withdrawal of versions of the brand name painkillers Darvon, Darvon-N, and Darvocet-N. Generic manufacturers of propoxyphene-containing products, which include Cornerstone, were requested to voluntarily remove their products as well.