No More Lumizyme Production at Genzyme's Allston Facility?No More Lumizyme Production at Genzyme's Allston Facility?
August 7, 2009
Lumizyme is the name of alglucosidase alfa for the U.S. market, to be approved by the FDA.
A Seeking Alpha article states that after temporary interruption of production at Genzyme's Allston facility "all Myozyme/Lumizyme (alglucosidase alfa) production will occur at the company's 4,000 L scale facility in Belgium." The article further states that the FDA approval of the 4,000 L process (for the U.S. market) is expected in the first quarter of 2010, and that U.S. patients in the Myozyme Temporary Access Program will be transitioned from the product produced at the 2,000 L scale to that produced at the 4,000 L scale and will be providing 4,000 L data to the FDA to support this transition.
Apparently, Pompe patients will be supplied with drug from the 4,000 L facility in Belgium on the long term, and no more Lumizyme will be produced at the Allston facility, whereas the "production of Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase for injection) has resumed." By the way: patients in Europe and worldwide except U.S. receive the drug produced in Belgium since production started there.