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

Offshore California sunset (photo by Bruce V. Bigelow)

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: [[ticker: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: [[ticker:CHRS]]) of Redwood City, CA, and its development partner Baxalta (NYSE: [[ticker: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

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.