This past week started out with a big alliance between Gilead Sciences and Nimbus Therapeutics in one of biotech’s biggest contests—the race to treat nonalcoholic steatohepatitis, or NASH. Those who packed Biogen on Wednesday for our biotech forum, “What’s Hot in Boston Biotech,” got an inside look at what led to that deal and where it fits into the NASH spectrum. I’ll have more on that soon, but as luck would have it, there was bit more news this week on the NASH frontrunner, Intercept Pharmaceuticals, as well. Those stories and more below:
—An advisory panel recommended that the FDA approve obeticholic acid (OCA), a drug developed by New York-based Intercept Pharmaceuticals (NASDAQ: ICPT) as a potential treatment for a rare liver disease known as primary biliary cirrhosis. The vote was unanimous, 17-0, setting the stage for Intercept to likely win FDA approval of OCA when the agency makes its decision next month. Approval of OCA for PBC would be just the first step for Intercept, however. Over the next few years, all eyes will be on a Phase 3 test of OCA in NASH, a much more common liver disease. Alex Lash has more here on Intercept’s NASH prospects, as well as some of the other players in the NASH arena.
—One of those players was Cambridge, MA-based Nimbus Therapeutics—at least until Monday, when Gilead Sciences (NASDAQ: GILD) agreed to pay $400 million up front, and potentially as much as $1.2 billion, to acquire a drug Nimbus has been developing for NASH. While the deal adds another prospect to the NASH pipeline Gilead has been amassing, it’s also a successful outcome for an experiment by Atlas Venture to structure Nimbus as a limited liability company.
—It took one day for Pfizer and Allergan’s $160 billion megamerger to fall apart. New York-based Pfizer and Ireland-based Allergan scuttled their deal on Wednesday after the federal government on Tuesday introduced new rules aimed at limiting so-called inversion deals, in which American companies lower their tax bills by merging with an overseas firm. It’s the second time since 2014, incidentally, that Pfizer has been rebuffed in an attempted inversion—it tried and failed to buy AstraZeneca two years ago. Still, the breakup leaves two large companies with boatloads of cash to spend, a story to watch in biotech going forward. The day after the merger fell through, for instance, Allergan immediately cut a deal with the U.K.’s Heptares Therapeutics on some potential Alzheimer’s drugs.
—In other dealmaking news, Waltham, MA-based Tesaro (NASDAQ: TSRO) inked a partnership with Johnson & Johnson on its experimental poly ADP-ribose polymerase, or “PARP” inhibitor, known as niraparib. J&J has grabbed worldwide rights, aside from Japan, to niraparib in prostate cancer. Tesaro got $35 million up front and could see another $415 million overall in the deal. J&J also made a $50 million equity investment in Tesaro, which has been developing its PARP drug in ovarian and breast cancer. Here’s more on PARP drugs from a recent story on stealthy Lexington, MA-based startup Ribon Therapeutics.
—Shares of Cambridge-based Bind Therapeutics (NASDAQ: BIND) fell about 25 percent as the company announced it would lay off 38 percent of its work force and shift its research and development strategy. Bind is working with an investment bank to explore strategic alternatives, which include a potential collaboration deal, capital raise, or an asset sale.
—Waltham, MA-based Entasis, an antibiotics startup spun out by AstraZeneca last year, raised a $50 million Series B round led by Clarus Ventures. Entasis is developing antibiotics for drug-resistant gram-negative infections. Its lead drug, currently in mid-stage testing, is an intravenous antibiotic for gonorrhea.
—The FDA approved a biosimilar version of J&J’s blockbuster autoimmune disease drug infliximab (Remicade). The biosimilar, marketed as Inflectra and developed by Korea-based Celltrion, is the second such drug that the FDA has approved so far (Novartis’s biosmilar version of filgrastim (Neupogen) was the first). Biogeneric infliximab is expected to be priced some 20 to 30 percent lower than the J&J version, according to this Reuters report.
—Shares of Cambridge-based Vericel (NASDAQ: VCEL), the company formerly known as Aastrom Biosciences, fell more than 38 percent after some new data emerged from a mid-stage study of its experimental cell therapy for heart failure, known as Ixmyelocel-T. The data, published in the peer reviewed journal The Lancet, showed that Vericel’s treatment missed some secondary goals in its trial. Aastrom changed its name to Vericel after acquiring some cell therapy and regenerative medicine products from Sanofi in 2014. The Boston Business Journal has more on the new data here.
—Woburn, MA-based antibody discovery shop Abpro got a $3.5 million equity investment from China’s Essex Bio.
—Cambridge-based Ironwood Pharmaceuticals (NASDAQ: IRWD) said that an exploratory mid-stage study testing experimental drug IW-9179 in patients with diabetic gastroparesis—a gastrointestinal complication of diabetes—failed. Ironwood has discontinued development of the drug in gastroparesis as a result.