Shire is on the verge of riding to the rescue of Gaucher patients who've faced persistent drug shortages due to Genzyme's well-documented manufacuring woes -- and exclusive market position.
Shire has filed applications with the European and US regulators to produce its Gaucher disease drug Vpriv (velaglucerase alfa) at a new manufacturing site in Lexington, Massachusetts, setting it on track to start boosting supplies to patients in 2012.
The company said the facility will give it flexibility to meet global demand for its other rare disease treatment, Replagal (agalsidase alfa) for Fabry disease, by freeing up manufacturing capacity at another plant in Alewife. The Lexington facility already has approval from the EMA for the purification of Replagal, according to Shire.
Posted by Bruce Lehr Dec 1 2011.