West Coast news this week was dominated by thumbs. Amgen, Otonomy, and Kythera all got a regulatory thumbs-up for their products. Some thumbs were down, however. Celladon’s cardiovascular gene therapy missed two big goals in a late-stage trial. Meanwhile, San Francisco-based Versant Ventures had a big week, announcing a sale of one portfolio company in San Diego (see item below), a big round of funding for a second in Cambridge, MA, and an option-to-acquire deal for a third in Toronto. In light of the three deals, Xconomy took a deeper look this week at Versant’s reinvention. Have a look, then come back and get to the roundup.
—Well, wattle y’know? Kythera Biopharmaceuticals (NASDAQ: KYTH) of Westlake Village, CA, won FDA approval Wednesday for Kybella, an injection meant to shrink double chins by destroying the fat—called submental fat—under the skin. The good news didn’t insulate Kythera from the week’s market downturn, however. While biotech indices were down 3 percent Thursday, Kythera shares sagged more than 4 percent.
—Amgen (NASDAQ: AMGN) of Thousand Oaks, CA, said an FDA advisory panel voted 22-1 to recommend that the agency approve Amgen’s immunotherapy talimogene laherparepvec for melanoma, a form of skin cancer. Known as T-vec, the drug is a modified virus that attacks tumor cells and stimulates the immune system to do the same. The near-unanimous vote came two days after the release of FDA documents that raised several questions about the drug.
—San Diego’s Otonomy (NASDAQ: OTIC) reported positive results for two late-stage trials of its lead product and said the FDA will consider the drug for approval. AuriPro is a gel formulation of the antibiotic ciprofloxacin designed to treat middle ear infections in children who undergo tympanostomy tube placement surgery. With the FDA’s green light, the gel could be commercially introduced early next year.
—Shares of Celladon (NASDAQ: CLDN) plunged more than 80 percent Monday after the San Diego biotech said its cardiovascular gene therapy agent Mydicar had flunked both the primary and secondary endpoints of CUPID2, a mid-stage clinical trial. Celladon said it would implement layoffs and other cutbacks. The company ended 2014 with $85 million in cash and said it should be enough to continue operating for a year.
—South San Francisco, CA-based MyoKardia announced a $46 million Series B round, the third time in a month that a biotech backed by Third Rock Ventures has raised a B round without Third Rock’s participation. MyoKardia is developing drugs to treat genetic heart diseases called cardiomyopathies.
—Seattle’s Theraclone Sciences raised a Series C round that could reach $4.4 million. The cash, from the Wellcome Trust and others, will fund a program to screen Ebola survivors and find antibodies that might be used as future treatments for the disease. BIO Ventures for Global Health, also of Seattle, will help manage the project.
—Viking Therapeutics (NASDAQ: VKTX), San Diego’s newest public biopharmaceutical company, closed Wednesday at $8.96 a share, after gaining nearly a dollar, or 12 percent, in its first day of trading. The three-year-old company, which is developing metabolic and endocrine disorder therapies, priced its IPO offering of 3 million shares at $8 a share Tuesday night. Viking licensed five drug compounds from another San Diego biotech, Ligand Pharmaceuticals, which invested $9 million in the IPO.
—OncoGenex Pharmaceuticals (NASDAQ: OGXI) of Bothell, WA, and Vancouver, BC, said Thursday it has regained from Teva Pharmaceutical the rights to its lung cancer drug custirsen and will scale back the size of its Phase 3 clinical trial.
—San Diego’s Quanticel Pharmaceuticals, which is developing technology to analyze the genetic diversity within the cells of a tumor, was acquired by Celgene (NASDAQ: CELG) for $100 million upfront and potentially $385 million more.
—Carmenta Bioscience, a Palo Alto, CA-based diagnostics startup, was acquired for an undisclosed sum by San Diego’s Progenity. Carmenta is developing a blood test to confirm cases of preeclampsia, a leading cause of death for pregnant women and their babies.
—San Diego-based GreatCall this week continued its transition from phone company to health and safety services company for people 65 and over. It introduced technology that uses an accelerometer and proprietary algorithm to determine if a user has fallen—and to automatically notify a GreatCall emergency operator. GreatCall was founded a decade ago to provide easy-to-operate Jitterbug phones and service.