|Healthcare Review: Chembio Diagnostics, Aastrom Biosciences, Gilead, Halozyme, Zogenix|
|By Staff and Wire Reports|
|Wednesday, 09 April 2014 12:26|
On the basis of its move to a direct distribution model, Chembio Diagnostics ($CEMI) terminates its U.S. STAT-PAK distribution agreement with Alere (ALR) (formerly Inverness Medical Innovations). Alere had the rights since 2006 to sell the firm's STAT-PAK HIV assays in the U.S. under its Clearview brand. CEMI is currently in the midst of a sales force build out.
The independent Data & Safety Monitoring Board for the Phase IIb trial of Aastrom Biosciences' ($ASTM) ixmyelocel-T for the treatment of advanced heart failure has recommended that the study continue without any changes. The recommendation follows an interim review of safety data. Aastrom expects to complete enrollment for the trial in H2.
The World Health Organization has joined those calling for a reduction in the prices of new Hepatitis C drugs, such as Gilead's ($GILD) Sovaldi and Jonhson & Johnson's ($JNJ) Olysio. In the U.S., Sovaldi costs $84,000 and Olysio $66,000.Around 150M people worldwide suffer from chronic hepatitis C, but the vast majority live in poor countries that can't afford the price. Pharmaceutical companies could follow the model that was used to bring the cost of HIV treatments down in the developing world, and Gilead is already giving Egypt a 99% discount on Sovaldi.
The FDA places Halozyme's ($HALO) pancreatic cancer Phase 2 trial on clinical hold. The agency takes action on the basis of the company's recent decision to stop the trial while it investigates possible differences in thromboembolic events between the PEGPH20 and non-PEGPH20 groups.
Zogenix ($ZGNX) presented its case against Massachusetts Gov. Patrick's March 27 ban on Zohydro yesterday in the U.S. District Court in Boston. The company seeks an immediate order staying the ban. A follow up hearing is scheduled for April 14.