Genzyme, National Institutes of Health metabolic news
NIH declined a petition by three Fabry's disease patients to exercise its march-in powers under the federal Bayh-Dole Act to grant an open license to two U.S. patents covering the production of Genzyme's Fabry's disease drug Fabrazyme agalsidase alfa. The agency said granting patent rights to a third party would not solve the short term supply shortage of Fabrazyme because "years of clinical studies and regulatory approval" would be necessary before another agalsidase alfa product could reach the market. NIH said that it would reconsider its decision if a third party could provide a plan to obtain FDA approval of such a product before Genzyme can meet the demand for Fabrazyme. Supplies of Fabrazyme have been limited since a vesivirus infection temporarily shut down the plant where it is made last year. In August, the company said it was on track to increase shipments of the drug in 4Q10 (see BioCentury, Aug. 9). ...