FDA Approves Optimer Antibiotic, Amylin Wins Legal Round Against Lilly, Investors Excited by Orexigen Move, & More San Diego Life Sciences News
The long Memorial Day weekend made for a short roundup of life sciences news this week. So we’ll be brief.
—The FDA approved Optimer Pharmaceuticals‘ drug application for fidaxomicin (Dificid) as a new treatment for the nasty intestinal infection caused by the Clostridium difficile bacterium. Optimer says its treatment cures patients about 90 percent of the time, and fewer patients return with problems than patients who get vancomycin, the standard antibiotic.
—Optimer officials said, though, that fidaxomicin will cost $2,800 for a 10-day course of capsules to treat potentially deadly cases of C. difficile. That’s about twice as much as vancomycin, the only other government-approved therapy for the infection, according to The San Diego Union-Tribune.
—A federal judge in San Diego issued a temporary restraining order against Indiana’s Eli Lilly (NYSE: LLY) that was sought by San Diego’s Amylin Pharmaceuticals (NASDAQ: AMLN). Amylin sued Lilly for violating their marketing agreement for Amylin’s diabetes drug exenatide after Lilly signed a similar marketing deal with Germany’s Boehringer Ingelheim for a rival diabetes drug. A Lilly executive called the TRO “disappointing” in a statement and said, “Amylin’s allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”
—San Diego’s Orexigen Therapeutics (NASDAQ: OREX), said it will hold a live webcast and conference call early Friday to provide an update on its requested regulatory approval for its weight loss drug, a combination of naltrexone and buproprion (Contrave). The announcement prompted a buying spree on Wall Street that pushed Orexigen shares up 18 percent, or 51 cents, to $3.34. The U.S. Food and Drug Administration turned back Orexigen’s new drug application in February, saying Orexigen and its Big Pharma partner, Japan’s Takeda Pharmaceutical, need to do some more clinical studies of the drug’s effects on heart function.
—San Diego’s Somaxon Pharmaceuticals is fighting efforts by four generic drug-makers to invalidate Somaxon patents that are supposed to protect its sleeping pill doxepin (Silenor) through 2027. The four companies want to sell lower-cost generic versions of doxepin.
—Polaris Venture Partners, which counts San Diego’s Fate Therapeutics and MedVantx among the life science startups in its portfolio, is opening an office in Palo Alto, CA—after closing its shop in Seattle. Dave Barrett, a general partner at the Boston-based VC firm, told Bob it became more and more important for Polaris to have a strong base of operations in the Bay Area.