Synta Melanoma Drug Trial Halted, Drug Regulators Hand Genzyme Mixed Bag, Ariad and ImmunoGen Reach Milestones, & More Boston-Area Life Sciences News

3/4/09

It was a bit of a rollercoaster for New England’s biotech firms this last week, with Synta Pharmaceuticals taking the worst dip.

—Clinical Data (NASDAQ:CLDA) of Newton, MA, has raised $50 million in a convertible debt financing aimed at supporting late-stage development of its depression drug, vilazodone, and its cardiac imaging agent apadenoson (Stedivaze).

—There was a flurry of regulatory news for Genzyme (NASDAQ: GENZ). The Cambridge, MA-based biotech giant won two long-awaited approvals, one from the FDA for its long-lasting injection hylan G-F 20 (Synvisc-One) for treating pain from osteoarthritis of the knee, and the other from the European Commission for batches of its Pompe disease drug, alglucosidase alfa (Myozyme), produced at its Belgium plant in 4,000-liter bioreactors. But the FDA said it would not yet approve batches of the drug made in 2,000-liter bioreactors for sale in the U.S. market. (Batches of the drug made in 160-liter vats have been approved in the U.S. since 2006, and those made at the 2,000-liter scale are currently approved in more than 40 countries.) In response to the unexpected setback, Genzyme took 12 cents a share off its annual earnings forecast; the firm said it hopes to address the agency’s questions within three to six months.

Luke got a briefing from Biotechnology Industry Organization president Jim Greenwood on how the group believes the economy and changing political environment will affect its more than 900 member companies and how it would like the government to support those companies’ efforts. The current numbers from BIO are grim, with about one-third of all publicly traded biotech companies having less than six months of cash on hand and only about one in 10 public biotechs in the black.

—Also grim was the news from Lexington, MA-based Synta Pharmaceuticals (NASDAQ: SNTA), which said it had halted a clinical trial involving more than 630 melanoma patients because more patients receiving the company’s experimental drug elesclomol in addition to traditional chemotherapy were dying compared with those who got the chemo alone. The failure of the trial was a huge blow for Synta, which has no products on the market.

—Ariad Pharmaceuticals (NASDAQ: ARIA) of Cambridge, MA, earned a $10 million milestone payment from its partner, Merck, in connection with the start of a mid-stage clinical trial of Ariad’s experimental drug for lung cancer.

—Waltham, MA-based ImmunoGen earned a similar milestone payment, worth $6.5 million, from partner Genentech when dosing of patients began in a late-stage clinical trial of T-DM1, a breast cancer drug comprised of ImmunoGen’s cancer cell-killing agent linked to Genentech’s antibody trastuzumab.

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