Two prominent Bay Area biotech companies took their lumps in front of FDA advisory panels this week, which clearly sent some shivers through the startup community.
—Genentech, the U.S. unit of Roche, failed to persuade an FDA advisory panel to support the use of bevacizumab (Avastin) for women with a type of breast cancer that doesn’t overexpress the HER2 protein. The drug is already approved for colorectal, lung, brain, and kidney tumors, but analysts say the company could lose hundreds of millions in future revenue if it loses this promising market among breast cancer patients. The FDA has a deadline of September 17 to decide whether to keep breast cancer usage in the drug’s label.
—Mountain View, CA-based Vivus (NASDAQ: VVUS) was also unable to convince an FDA advisory panel that its obesity drug deserves a place on the U.S. market. This setback has implications not just for Vivus, which is counting on the weight loss drug to be its first real moneymaker, but also for competitors like San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) and Orexigen Therapeutics (NASDAQ: OREX). Tom Hughes, the CEO of an obesity drug developer in Boston, followed up with his perspective on what this means for the future of obesity drug development in a guest op-ed.
—I took time to profile one of the rising stars in the Bay Area venture industry, Kristina Burow of Arch Venture Partners. Burow, 36, hasn’t yet hit a home run for the Arch portfolio, but she has played a key role in starting some of its big idea companies of the past five years—including Sapphire Energy, Lycera, Receptos, and Siluria Technologies.
—Tethys Bioscience, the Emeryville, CA-based maker of a test that predicts an individual’s risk of getting diabetes, secured $33 million in an equity and debt financing. The company’s president, Mike Richey, talked in detail about how big Tethys thinks this new market could become, and how Tethys envisions it will save money for the healthcare system for years to come.
—Since Tethys was fresh in my mind, I followed up for a longer conversation with one of its early investors, Menlo Park, CA-based Mohr Davidow Ventures. Managing partner Bill Ericson talked about how MDV has been investing in personalized medicine companies like Tethys for the past seven years. While the concept of personalized medicine hasn’t gone mainstream yet, Ericson says it’s only a matter of time, and MDV is remaining patient, and continuing to bet big.
—Here’s a little story with a strong Seattle-SF Bay Area connection. Integrated Diagnostics, the company co-founded by biotech pioneer Leroy Hood, secured a $10 million second tranche of its $30 million Series A financing announced last October. Menlo Park, CA-based InterWest Partners led the deal for this company, which is seeking to analyze certain proteins found in a pinprick of blood that could suggest future risk of lung cancer.
—South San Francisco-based Achaogen secured one of the biggest biotech venture deals of the second quarter, pocketing $56 million, so I’ve been meaning to follow up with them for some time to find out what’s so interesting. CEO Kevin Judice offered up some revealing insights about his vision to create an antibiotic company that goes after multi-drug resistant bacterial infections.
—San Mateo, CA-based Itero Biopharmaceuticals secured its first partnership to develop a product, attracting support from generics maker Watson Pharmaceuticals (NYSE: WPI). Terms weren’t disclosed, although the companies plan to work together on a “biosimilar” drug for female infertility, a market estimated to be worth $1.2 billion.
—Lastly, we had a thought-provoking guest editorial from former Bayhill Therapeutics CEO Mark Schwartz on how the lack of will to finance early-stage projects is damaging the culture of innovation in biotech. He asks: “Where Will the New Disease Treatments Come From a Decade From Now?” If you have your own opinion on this, or any other issue that’s relevant to the local innovation community, send a draft over to me at [email protected] or Wade Roush, our San Francisco editor, at [email protected]