Amira’s Windfall Sale, Ardea Advances Gout Drug, Gov. Brown’s Jobs Plan Wins Biotech Support, & More San Diego Life Science News
What was my favorite local life sciences news over the past week? It would have to be the announcement that Apricus Biosciences made before the three-day Labor Day holiday. In case you missed it, we’ve got it here.
—Amira Pharmaceuticals CEO Bob Baltera talked with Luke about the fortuitous outcome of the company’s acquisition by New York’s Bristol-Myers Squibb (NYSE: BMY). The $325 million upfront payment yielded an immediate 10-fold return for Amira’s investors, who can still look forward to another $150 million in potential milestone payments. Best of all, two potentially lucrative drug development programs were not included in the deal, which gives Baltera and the Amira team an opportunity to start anew.
—Last week, Xconomy editor-in-chief Bob Buderi asked readers to vote on the bad corporate news most likely to get announced (i.e. buried) just before the long Labor Day holiday. The poll drew a lot of responses, but no one guessed what San Diego’s Apricus Biosciences (NASDAQ: APRI) would do. In a statement issued last Friday, Apricus corrected four press releases that had declared three of the company’s over-the-counter topical creams had been “approved” or “cleared” by the FDA. Apricus says it should have said instead that its new products only “complied” with a regulatory process for over-the-counter drugs that requires no formal approval or clearance.
—During a swing through San Diego, California Gov. Jerry Brown won endorsements from a several life science leaders for his “California Jobs First” plan. Brown wants to change a two-year-old business tax rule—which he says would generate $1 billion in revenue—and use the proceeds for tax credits to California-based companies that buy new manufacturing equipment. David Gollaher of the California Healthcare Institute endorsed the plan, saying, “The present employment crisis will not self-correct; we need vision and creativity in the public sector.”
—Three San Diego life sciences companies secured additional funding. Biomatrica, which has a process to “shrink wrap” biological samples to protect them from degradation, raised slightly more than $3 million. Celladon, which is developing gene therapy treatments for heart attacks and other serious cardiovascular events, raised $250,000 in debt and securities. And Abrexa Pharmaceuticals raised $500,000 in a combination of debt and equity financing.
—San Diego’s Ardea Biosciences (NASDAQ: RDEA) said it had successfully reached agreement with FDA regulators on the overall size and design of its planned Phase 3 clinical studies of lesinurad, its drug candidate for treating gout. Ardea said it also had agreed with FDA regulators on the study’s primary endpoints, the total safety database proposed for NDA filing, manufacturing plans for both drug substance and drug product, the preclinical toxicology program and the clinical pharmacology program. Ardea plans to begin its Phase 3 studies before the end of this year. Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream.
—In a BioBeat column that revealed his passion for both fantasy football and biotech, Luke made some tongue-in-cheek comparisons of U.S. life sciences personalities, companies, and drugs with some big-name football players. Xconomy readers who understand biotech and football might appreciate his comparison of former Chargers’ running back LaDanian Tomlinson’s fading superstardom with Amgen’s erythropoietin anemia drug franchise. He also compared FDA regulators to Baltimore Ravens’ hard-hitting linebacker Ray Lewis for their concussion-causing tackles of two San Diego diabetes drug developers—Arena Pharmaceuticals (NASDAQ: ARNA) and Orexigen Therapeutics (NASDAQ: ticker:OREX]]).