East Coast Biotech Roundup: Berg, Forma/Celgene, Intarcia, & More
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amended the protocol for the trial, but hasn’t specified how as of yet.
—New York’s Weill Cornell Medical College has struck a three-year deal with Belgian drugmaker UCB to try to move forward three programs coming out of the university’s research in bone disorders, metabolic disease, and genetics. One project deals with ways to build up bones and treat people with disorders like osteoporosis. Another is looking into how the body becomes insulin resistant. And a third study centers around genetic variations that lead to immunological disorders like rheumatoid arthritis. Researchers from both organizations will work together on advancing the projects.
—An FDA advisory panel this week unanimously voted in support of approving Lexington-based Cubist Pharmaceuticals’ (NASDAQ: CBST) antibiotic for bacterial skin infections, tedizolid. The FDA will decide whether to approve the drug—to be sold under the name Sivextro—by June 20. Cubist acquired tedizolid when it bought Trius Therapeutics last year.
—Celgene snapped up 1.1 million more shares of Acceleron Pharma (NASDAQ: XLRN), giving the Cambridge-based company about $47.1 million in new cash. Celgene now has a 14.8 percent stake in Acceleron, which went public in September. Celgene had a 12.3 percent stake before Acceleron’s IPO. The two are partners on a couple of experimental drugs Acceleron is developing for anemia, multiple myeloma, and other diseases. Shares of Acceleron jumped about 15 percent on the news.
—The high-stakes PCSK9 race took center stage earlier this week at the annual meeting of the American College of Cardiology. New York-based Regeneron (NASDAQ: REGN) (and partner Sanofi), and Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) both presented updated, similarly promising results from the ongoing studies of their prospective cholesterol-lowering PCSK9 blockers. The belief is that PCSK9 blockers can be a valuable option when combined with statins, or for those who don’t respond well to them—a potentially huge market. These drug candidates are proving they can effectively lower low-density lipoprotein (LDL) or “bad” cholesterol on their own and with statins, but it’s still an open question whether payers will pay up for PCSK9 blockers before seeing the results of ongoing long-term “outcomes” studies which should indicate whether these drugs lead to fewer heart attacks. Amgen looks to be in position to find out first—it reported the details of its latest arm of its Phase 3 study, and expects to file an application for approval by the end of the year.
—Cambridge-based Biogen Idec (NASDAQ: BIIB) won FDA approval of its long-acting hemophilia B drug, which the company will sell under the brand name Alprolix. The drug is to be administered once a week, compared to current treatments like Baxter International’s Advate, which requires an infusion every two or three days. Baxter is also developing a longer-lasting hemophilia B treatment, as is Novo Nordisk.
—Rockland, MA-based EMD Serono, the U.S. drugmaking arm of Merck KGaA, has teamed with The Broad Institute of MIT and Harvard and Pfizer to try to unearth new treatments for lupus. The Broad Institute will analyze genetic samples from lupus patients and use computer models to attempt to unearth new drug targets and find biomarkers and molecular drivers of the disease. EMD and Pfizer will get access to all the data and analysis, and can send over their own scientists to chip in on the work.
—Watertown, MA-based EnVivo Pharmaceuticals, the Alzheimer’s and schizophrenia drug developer that ex-Millennium chief Deborah Dunsire took over last year, has changed its name to Forum Pharmaceuticals. The newly-named Forum said the change doesn’t represent a change in organizational structure or to its investor base.