Biotech Analysis

EASL Roundup: Anadys, Salix, Schering

In the flurry of EASL news breaking today, shares of Anadys Pharmaceuticals Inc. plunged 42 percent in midday trading amid safety concerns about polymerase inhibitor ANA598. Meanwhile, Schering-Plough Corp. released final data from a Phase II trial of protease inhibitor boceprevir in treatment-naïve HCV patients. And Salix Pharmaceuticals Ltd. said the antibiotic rifaximin provided significant protection against hepatic encephalopathy breakthrough episodes in a Phase III trial.

NitroMed, on Verge of Merger, Sells Technology to NicOx for $7.8M

NitroMed Inc. agreed to sell and license certain patents and patent applications associated with its nitric oxide-based technology platform to NicOx SA in exchange for €6 million (US$7.8 million), including €2 million at signature and a further €4 million upon NicOx fulfilling certain future business criteria. NicOx is not acquiring any rights to BiDil (isosorbide dinitrate/hydralazine hydrochloride), the heart drug targeted specifically to black patients. NitroMed’s merger agreement with Deerfield Management recently was approved by NitroMed shareholders and is expected to close “as soon as practicable,” the company said.

Cattle Genome Studies Could Advance Biomedical Research

As researchers published two genome studies of the domestic cattle, Bos Taurus, in Science, the natural assumption is that their most direct applications of the study are in livestock biology. But Harris Lewin, author of a Perspectives piece that accompanies the papers, said in a podcast published to the Science website that the findings most likely will bring advances in biomedical research as well, because cows appear to be resistant to several types of diseases that plague humans. “Cattle rarely develop spontaneous cancers,” he said. Likewise, “I don’t know of a single example of an autoimmune disease in cattle.”

FDA Won’t Fight Ruling on Nonprescription Plan B for 17-Year-Olds

The FDA late Wednesday said it would comply with a judge’s order to permit the emergency contraceptive Plan B to be sold to women as young as 17 without a prescription. In a brief statement, the agency said it would not appeal last month’s order from Federal Judge Edward Korman, who called the FDA’s August 2006 action to restrict over-the-counter sales of Plan B to women 18 years or older a decision that was based on political pressure rather than permissible health and safety concerns.

Acorda’s Quick Turnaround on Fampridine NDA Boosts Shares

Acorda Therapeutics Inc. managed to ease some investor concerns with its quicker-than-expected resubmission of a new drug application for Fampridine-SR, a drug designed to improve walking ability in multiple sclerosis patients, following a refusal to file (RTF) letter. Shares of the Hawthorne, N.Y.-based firm were up 18 percent in morning trading Thursday. Acorda reported receiving the RTF late last month and said the FDA pointed to formatting issues with the electronic filing document and requested pharmacokinetic data from a completed fed/fasted study, plus some additional analytic information.

Also in the News:

Alethia Biotherapeutics, Ascenion, Celera, Celgene, DeCode, Diamyd, HUNT Biosciences, Icagen, Idenix Pharmaceuticals, MedMira, Nuvo Research, Progen, SAFC Biosciences, Sanaria, Targacept, Trion Pharma, Trubion, Vical, Vivalis