CHMP rebuffs Elelyso

Protalix Biotherapeutics Inc. (NYSE-A:PLX; Tel Aviv:PLX) and partner Pfizer Inc. (NASDAQ:PFE) said EMA's CHMP recommended against approval of an MAA for Elelyso taliglucerase alfa to treat Type I Gaucher's disease. CHMP concluded Elelyso has a positive benefit-risk profile but said approval would violate the existing EU Orphan Drug exclusivity for a similar enzyme replacement therapy, Vpriv velaglucerase alfa from Shire plc (LSE:SHP; NASDAQ:SHPGY). CHMP added that Elelyso is not eligible for exemptions because there is no evidence that the product is clinically superior to Vpriv or that Vpriv is in short supply. Vpriv, a glucocerebrosidase enzyme replacement therapy, was approved in the EU in 2010 and has 10 years of exclusivity. ...