Advancing Drugs at Roche, Sophiris, Coherus, and Other Bio News

Xconomy San Diego — 

An economic impact report released this week by the California Life Sciences Association found that life sciences companies in the Golden State currently have 1,235 new drugs in the development pipeline—and it seemed like this week there was news on each one. Here’s our wrap of the life sciences news from the West Coast

—The FDA approved cobimetinib (Cotellic), which was first developed by South San Francisco, CA-based Exelixis (NASDAQ: [[ticker: EXEL]]) before Genentech, now part of Roche, bought much of the rights and took it through late-stage clinical trials for advanced melanoma. It was approved as a combination therapy with Genentech’s vemurafinib (Zelboraf). The expected approval is a big step back for Exelixis, as we wrote about in August. The biotech will split cobimetinib profits with Genentech.

—In a reversal of fortune, San Diego-based Sophiris Bio (NASDAQ: SPHS said topsalysin, its biologic drug for treating an enlarged prostate, met the primary goal of a 52-week clinical trial by showing a significant improvement in patient symptoms that include frequent or difficult urination. The results sent shares of Sophiris soaring—roughly 11 months after the stock tanked after Sophiris reported interim results (three months into the trial) that failed to show effectiveness.

Amplyx Pharmaceuticals said it closed on $40.5 million in Series B financing, and plans to use the capital to advance development of APX001, a new anti-fungal compound for treating life-threatening fungal infections. RiverVest Venture Partners led the round, which included NEA, BioMed Ventures, and individual investors. Amplyx intends to take advantage of incentives created as part of the GAIN Act of 2012.

—One of the rare small or modestly sized firms working on biosimilars hit a clinical milestone, too. Coherus BioSciences (NASDAQ: CHRS) of Redwood City, CA, and its development partner Baxalta (NYSE: BXLT) announced positive Phase 3 data for their biosimilar based on etanercept (Enbrel). It remains to be seen, however, if the wave of biosimilars heading toward market will make a noticeable dent in the staggering cost of U.S. healthcare.

—Amgen is also working on biosimilars, and its copycat version of adalimumab (Humira), the world’s top-selling drug, posted good Phase 3 results this week.

—San Diego’s Avalon Ventures formed Iron Horse Therapeutics, a new biotech with a promising new drug candidate for treating amyotrophic lateral sclerosis (ALS), a neuro-degenerative disease also known as … Next Page »

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