[Corrected 11/13/14, 5:40 pm. See below.] West Coast spotlights this week are on new ways to fight disease. Some are close to getting to market: Amgen announced late-stage development and regulatory news about two drug programs that aim to treat psoriasis and heart disease through novel biomolecular mechanisms.
Some are a bit farther away: Bicoastal firm Intarcia signed its first major rights-sharing deal for its under-the-skin pump that, if approved, could change the way diabetes is treated. And some are still extremely experimental: UC Berkeley professor Jennifer Doudna won a life-sciences prize for her work that has helped turn an ancient bacterial defense system called CRISPR into a gene-editing research tool—and possibly a new kind of gene therapy. Let’s get to the roundup.
—Intarcia Therapeutics, with operations in Hayward, CA, and Boston, inked a deal with French drug firm Servier that gives Servier rights outside the U.S. and Japan to Intarcia’s implantable pump, which releases exenatide, a drug to treat Type 2 diabetes. Currently in huge Phase 3 tests, the pump would be refilled and re-implanted once or twice a year. Servier is paying Intarcia $171 million up front with up to $880 million more as the product reaches various milestones.
—Seattle’s Dendreon (NASDAQ: [[ticker:DNDN]]) filed for bankruptcy Monday. The firm is weighed down with a $620 million debt load coming due in 2016 and meager revenues from prostate cancer treatment sipuleucel-T (Provenge). An auction to sell the company is set for Feb. 3 at the latest, but if a bid of at least $275 million doesn’t materialize, the company could go through a recapitalization instead.
—Carlsbad, CA-based Isis Pharmaceuticals (NASDAQ: [[ticker:ISIS]]) said it intends to offer $425 million in convertible debt. The deal will let Isis retire as much as $140 million of existing debt, then use the remainder to retain control over and potentially commercialize certain drugs in its pipeline.
—Thousand Oaks, CA-based Amgen (NASDAQ: [[ticker:AMGN]]) and its development partner AstraZeneca (NYSE: [[ticker:AZ]]) said Tuesday an 1,800-patient Phase 3 trial of psoriasis treatment brodalumab met its primary endpoints. The trial is one of two comparing brodalumab to the marketed psoriasis treatment ustekinumab (Stelara). Ustekinumab inhibits proteins called IL-12 and IL-23; brodalumab (and other antibody treatments) are going after the related protein IL-17. Results from the second trial are expected by the end of 2014, Amgen said. A trial comparing brodalumab to placebo released top-line data in May. [An earlier version of this paragraph mistakenly identified the number of head-to-head trials vs. ustekinumab.]
—Amgen also said that its high-cholesterol treatment evolocumab has been accepted for review by the FDA, which will make its approval decision by late August 2015. Evolocumab is a PCSK9 inhibitor, part of a new promising class of drugs that Amgen, Regeneron, and others are developing for cardiovascular disease. Regeneron, working with Sanofi, paid BioMarin $67 million earlier this year for an FDA voucher that lets it cut four months from the approval review time. (Xconomy wrote about the FDA voucher program here.)
—University of California, Berkeley professor Jennifer Doudna won the 2015 Breakthrough Prize in Life Sciences for her research into the CRISPR/Cas9 bacterial defense system, which has become a new method to edit genomes, with potential use in therapeutics. Doudna and her co-winner, French researcher Emmanuelle Charpentier, published a paper in 2012 that is often cited as the key that unlocked the potential of the system. Doudna is a cofounder of Editas Medicine in Cambridge, MA, which is pursuing CRISPR/Cas9-related therapeutics, and of Caribou Biosciences in Berkeley. The prize is part of the series created last year by several Silicon Valley moguls.
—San Diego’s Auspex Pharmaceuticals (NASDAQ: [[ticker:ASPX]]) said the FDA has awarded orphan drug status to SD-809, currently in a late-stage trial as a treatment for Huntington’s chorea. The designation provides certain development and commercial incentives, including eligibility for a seven-year period of U.S. market exclusivity following product approval.
—Veracyte (NASDAQ: [[ticker:VCYT]]) of South San Francisco, CA, said Wednesday that Sam Colella, a managing director at Versant Ventures, has stepped down from its board. Colella’s replacement is John Bishop, the current CEO of diagnostics firm Cepheid and a 30-year veteran of device and diagnostics firms. Veracyte makes a test that helps determine whether certain thyroid nodules are benign.
—Avanir Pharmaceuticals (NASDAQ: [[ticker:AVNR]]) of Aliso Viejo, CA, said Nov. 7 it was pessimistic that its migraine treatment AVP-825, a drug-device combination, would win FDA approval under the current deadline of Nov. 26. The FDA has raised questions about the company’s clinical data and is asking for more design work and testing, Avanir said.
—IBM’s Watson Group (NYSE: [[ticker:IBM]]) made an undisclosed investment in Poway, CA-based Pathway Genomics to help advance Pathway Panorama, a mobile app that uses Watson technology to answer health-related questions based on a user’s own genetic data. While the amount was not disclosed, IBM said its investment brings total funding for Pathway Genomics to more than $80 million over the past six years.
—Oncology data provider Presage Biosciences of Seattle said Wednesday it has expanded its collaboration with Takeda Pharmaceutical.
