Biotech Analysis

Oral MS Drug Data a Mixed Bag at AAN

Two oral multiple sclerosis drugs – Merck Serono’s cladribine and Novartis AG’s FYT720 (fingolimod) – continued to show solid efficacy data but safety concerns prevented either one from emerging as a clear winner at the American Academy of Neurology meeting in Seattle. Both drugs met their primary endpoints in respective Phase III studies and are expected to be submitted for approval this year, yet some analysts say that, even in the increasingly crowded MS space, questionable safety profiles of newer drugs might not sway physicians from the more established – though possibly less efficacious – ABCR therapies.

Amylin, Lilly to Share Development Costs of Exenatide Pen for Diabetes

Amylin Pharmaceuticals Inc. and Eli Lilly and Co. have agreed to share the capital and development costs of exenatide in pen device form. Over the next few years, the two companies will share the initial capital investment of about $216 million, with Lilly making 60 percent of that investment. The firms also have initiated a Phase I/II study to examine a new exenatide once weekly suspension formulation. The trial began this month and initial findings are expected by the end of 2009.

H1N1 Vaccine Research Underway, but Nothing Decided on Production

The CDC has isolated a seed strain and is busy growing it for manufacturing of a vaccine against the 2009 H1N1 swine influenza, but has not yet distributed it to manufacturers, the acting head of the agency told reporters today. The current working plan, said Richard Besser, is to have manufacturers complete their production of seasonal influenza vaccines and then switch over to producing a vaccine against the new H1N1 strain, with a product available possibly by the fall. However, he said, the government’s current focus is ensuring a seasonal flu vaccine is available in adequate supplies for the 2009-10 season.

HIV Uses Endosomes, Not Direct Membrane Fusion, to Enter Cells

Among the ways to classify viruses is whether they need an acidic environment to fuse with the cells they infect. Some do, and some – most prominently HIV – don’t. Cells that need an acidic environment clearly enter into cells via endocytosis – that is, they are taken up when small parts of the cellular membrane pinch off and engulf them to form endosomes. In the May 1, 2009 issue of Cell, however, scientists show that HIV, too, enters cells through endosomes, rather than fusing with the host cell membrane directly.

Also in the News:

Aethlon, Alseres, Arrayit, Avexa, Basilea, Bayer, BioAxone, Biogen Idec, BioTime, Can-Fite, Coherix, CombiMatrix, Debiopharm, Energex Systems, ImmuneRegen, Ipsen, LifeCycle Pharma, Medicis, NeurogesX, Prometheus labs, Regeneron, Rockwell Medical, Rosetta Genomics, RXi Pharmaceuticals, Sepracor, Sequenom, XOMA, ZymoGenetics.