When Nabi Biopharmaceuticals Inc. revealed its plans to serve as a public shell for a reverse merger with Aussie biotech Biota Holdings Ltd., Raafat Fahim knew he'd face some opposition from shareholders.
As expected, the FDA green-lighted Vivus Inc.'s erectile dysfunction drug Stendra (avanafil) on Friday, but analysts and investors remain focused on the looming July 17 PDUFA date for obesity drug Qnexa (phentermine/topiramate).
Epizyme Inc. is expected to announce early Thursday a broad epigenetics partnership with Celgene Corp. that brings the small biotech $90 million up front, at least $160 million in milestone payments per compound and double-digit royalties.
After more than a year of evaluating ways to access U.S. shareholders, Aussie biotech Biota Holdings Ltd. settled on a merger with Nabi Biopharmaceuticals Inc.Nabi became a Nasdaq-listed cash shell following last year's Phase III failure of smoking cessation vaccine NicVAX. Despite encouraging Phase IIb data, the vaccine failed to improve abstinence from cigarettes in two Phase III trials. Nabi's stock plunged, and the Rockville, Md.-based biotech hired Piper Jaffray to explore strategic alternatives. (See BioWorld Today, July 19, 2011.)
This year, California became the seventh state to allow benefit corporations and the first state to allow flexible purpose corporations. Both are new business structures with a non-profit flare; they let companies pursue a social mission and make decisions based not only on profit maximization for shareholders, but on non-financial factors such as the interests of their employees, community and environment.
With partner Bristol-Myers Squibb Co. handling all costs for lead antibody ALD518 in autoimmune disease, Alder BioPharmaceuticals Inc. can apply the $38 million it just raised in Series D financing to its internal pipeline.
"I don't think any other sector of industry is more wasteful than health care," said Tomasz Sablinski, CEO of Transparency Life Sciences LLC. "Drug development is certainly very wasteful, and clinical trials are the champions of the world in wastefulness."
Shares of Halozyme Therapeutics Inc. fell 24 percent Monday after the biotech and partner Baxter International Inc. revealed the FDA needs more information to complete its review of subcutaneous immunoglobulin product HyQ.