Genzynme will spend Eu 250 M on a new manufacturing plant for its Pompe's disease drugs Myozyme and Lumizyme. The plant will be located in Geel, Belgium and the company expects commercial regulatory approval of the site to be secured by 2014.
The new Geel plant will have a maximum batch production capacity of 8000L and the existing Geel plant will add a thrid 12,000 L bioreactor. The expansion is meant to provide more capacity and better risk management for Genzyme. In recent years, the company has experienced well documented manufacturing failures (and is currently under a FDA consent decree as a result) that have led to global drug shortages of its orphan products.
Lumizyme and Myozyme are the only approved therapies for Pompe's disease at present. Genzyme services more than 1400 of the estimated 10,000 patients with these afflctions. The commercial potential of these Pompe's disease drugs are expected to rival its best-selling Cerezyme for the treatment of Gaucher's disease. Genzyme is projects sales growth in excess of 30% with these products - especially if supplies are available for the full year in 2011. Sales wereup 39% ($128 M total) in the 4th quarter of 2010.
Posted by Bruce Lehr January 20th 2011.