Protalix Biotherapeutics has suffered a setback in its bid to compete with Genzyme’s Cerezyme after regulators in the USA asked for more information on the Israeli company’s experimental Gaucher disease drug taliglucerase alfa.
Protalix filed a New Drug Application in December for taliglucerase alfa which is currently being provided to Gaucher’s patients in the USA and in the European Union under a compassionate use protocol. That protocol was triggered by the global supply shortage caused by Genzyme temporarily shutting down its manufacturing facility in Boston last year after a bioreactor was contaminated with a virus which affected production of Cerezyme (imiglucerase).
However, hopes of getting full approval quickly have hit a roadblock as the US Food and Drug Administration has requested additional data regarding the “chemistry, manufacturing and controls section of the NDA”, Specifically, the agency’s request focuses primarily on validation of the manufacturing process at Protalix’ upgraded facility.
The company stressed that “no additional clinical or preclinical information was requested” and “a validation plan for the company’s manufacturing process of taliglucerase alfa has already been established and reviewed by the FDA”. Protalix added that it anticipates submitting the requested data during the second quarter of 2010.
