Western biopharmaceutical companies hoping to capitalize on opportunities in the emerging China and India markets through collaborations and partnerships should be prepared to deal with potential legal and regulatory challenges related to intellectual property (IP), accounting and import-export standards.
Quanticel Pharmaceuticals Inc., a fledgling, privately held San Francisco biotech, Celgene Corp., of Summit, N.J., and California venture capital firm Versant Ventures have agreed to a 3.5-year, $45 million "build to buy" cancer drug collaboration.
Medivation Inc. stock doubled and then some following an announcement by the San Francisco-based biotech and partner Astellas Pharma Inc., of Tokyo, that results from an interim analysis of the Phase III AFFIRM trial of MDV3100 in men with advanced prostate cancer were so positive that the independent data monitoring committee recommended the trial be stopped and MDV3100 offered to the men who received placebo.
Exelixis Inc.'s stock plummeted 40.2 percent Tuesday following the South San Francisco biotech's announcement that it was unable to secure a special protocol assessment (SPA) from the FDA for its pivotal Phase III XL184-306 trial of cabozantinib (cabo) in end-stage castrate resistant prostate cancer (CRPC).Exelixis said it has stopped pursuing the SPA and plans to initiate the '306 trial by the end of 2011 with pain as the primary efficacy endpoint, to be followed in the first half of 2012 by the Phase III XL184-307 trial to evaluate overall survival time.
Omeros Corp. went down hard following news that the Seattle-based company's lead candidate OMS103HP did not meet endpoints in Phase III trials evaluating its ability to improve postoperative joint motion and function and reduce postoperative pain in patients who'd undergone arthroscopic anterior cruciate ligament (ACL) reconstruction surgery.
Palatin Technologies Inc. continued its comeback efforts by pricing an underwritten public offering of 23 million units of stock and warrants at $1 per unit, about 4 percent less than Wednesday's closing price. The offering is expected to net about $21.1 million – enough to get the company through the end of 2012 – with proceeds intended for a Phase II trial of bremelanotide for female sexual dysfunction, development of PL-3994 for asthma and development of new peptides for sexual dysfunction.
Amgen Inc. will lay off about 380 employees at several R&D sites and shift resources to several late-stage programs. The furloughs, effective Dec. 30, involve about 2 percent of the giant biotech's roughly 17,600 employees worldwide.
There's a lot of toenail and fingernail fungus among us, enough that Topica Pharmaceuticals Inc., has raised $27 million in a Series B financing to support a Phase IIb/III trial of the privately held Palo Alto, Calif.-based biotech's luliconazole topical antifungal agent for treatment of onychomycosis.
