Lots to report this week, and lots of it has to do with Genzyme’s manufacturing trials and tribulations.
—The FDA informed Genzyme that it would re-inspect one of those plants, in Allston, MA, which has been closed since June for decontamination after a virus was found to be contaminating the facility, and which was the subject of an FDA warning letter in February. The plant closure resulted in shortages of two of Genzyme’s best-selling drugs.
—Because of those shortages, the FDA granted U.K.-based specialty pharmaceutical company Shire permission to begin distributing its competitor to one of the two Genzyme drugs, the Gaucher’s disease treatment imiglucerase (Cerezyme), even before Shire completes clinical trials for its drug. Shire will provide the treatment, velaglucerase alfa, free to patients who enroll in a special protocol.
—A startup spun out of Dana-Farber Cancer Institute announced partnerships with Germany-based Merck KGaA, and Switzerland-based Debiopharm Group. Medford, MA-based MSM Protein Technologies will help its new partners develop antibody drugs that target complicated biological molecules called G-protein coupled receptors.
—Cambridge-based Vertex Pharmaceuticals (NASDAQ:VRTX) scored $105 million in an amended deal with Mitsubishi Tanabe Pharma; the deal focuses on manufacturing and sales rights to Vertex’s experimental treatment for hepatitis C, telaprevir.
—RNA interference drug developer RXi Pharmaceuticals (NASDAQ: RXII) of Worcester, MA, said it would raise $8.3 million in working capital through an offer of 2.4 million shares of common stock at $3.50 per share, and warrants for almost a million shares at $4.50 per share.
—Cardiorobotics raised $11.6 million in a Series A financing from Eagle Ventures, the Slater Technology Fund, the Pittsburgh Life Sciences Greenhouse, and others. The Newport, RI- and Pittsburgh, PA-based startup is developing “snake robot technology” for minimally invasive heart surgery.