Believe it or not, the troubles besetting Genzyme (NASDAQ: GENZ) were not the only life science stories coming out of the Boston area this week, although they sure grabbed most of the attention. So let’s get them all out of the way first:
—On Friday the 13th, the FDA said bits of steel, rubber, and fiber had been detected in vials of five major enzyme replacement drugs made by Genzyme, all manufactured at the company’s troubled Allston Landing plant in Boston. But the agency said that the problem affected only about 1 percent of Genzyme’s products, and that no serious side effects have been reported. In a statement, Genzyme said a review of its safety database “has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles.”
—On Monday the 16th, Genzyme got word that the FDA won’t approve its application to market its drug alglucosidase alfa (Lumizyme), a proposed treatment for Pompe disease, until the company fixes deficiencies at the Allston Landing facility, where it wants to mass-produce the drug in large batches. But Genzyme continues to make the drug in smaller batches and sell it under the name Myozyme.
—On Tuesday the 17th, shares in Carlsbad, CA-based Isis Pharmaceuticals (NASDAQ: ISIS) fell 16 percent after Isis and Genzyme released the full details of joint clinical trials of mipomersen, a cholesterol-lowering drug that the two companies see as a potential successor to Pfizer’s blockbuster atorvastatin (Lipitor). The drug lowered “bad” LDL cholesterol levels by 25 percent on average, but in several patients it raised liver enzymes to triple their normal levels, indicating potential liver damage. In new trials, Genzyme and Isis say they’re going to study what side effects, if any, mipomersen causes at different doses.
—On Wednesday the 18th, Genzyme said it had decided to scrap an experimental kidney disease drug, an “advanced phosphate binder,” after a clinical trial of 349 patients showed that it was no better at ridding phosphorus from the blood of dialysis patients than Genzyme’s existing drug sevelamer carbonate (Renvela). Genzyme’s two existing phosphate binders, which generate $850 million per year in sales, go off-patent in 2014, and the company is anxious to find a next-generation treatment.
—In non-Genzyme news, Chelmsford, MA-based Zoll Medical (NASDAQ: ZOLL), which makes cardiac defibrillators and other emergency medical devices, released a CPR training app for the Apple iPhone and iPod Touch that Ryan called the “most advanced” he’s seen. The “PocketCPR” app, which provides visual and audio instructions on proper CPR technique, could help lower the death toll from sudden cardiac arrest, which kills 300,000 Americans each year.
—Alkermes (NASDAQ: ALKS) of Cambridge, MA, said a 250-patient clinical trial showed that its drug naltrexone (Vivitrol), which is already used as a treatment for alcoholism, was more effective than a placebo at treating dependence on opioids such as heroin. The company plans to ask the FDA to approve this new use of the drug next year.
—Waltham, MA-based Polaris Venture Partners contributed to a $30 million Series B venture financing round for San Diego-based stem cell startup Fate Therapeutics. Kirkland, WA-based OVP Venture Partners led the deal, which also involved Arch Venture Partners, Venrock Associates, Astellas Venture Management, and Genzyme Ventures. Fate has collected about $50 million in venture funding all told.
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