Taliglucerase alfa is the company’s proprietary plant cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease. The FDA has granted orphan drug designation and fast track designation to taliglucerase alfa in 2009.
Protalix has reported positive top-line results from its pivotal phase III clinical trial of taliglucerase alfa in October 2009. In addition, the company has completed the filing of a new drug application for taliglucerase alfa with the FDA in December 2009.
In November 2009, the company entered into a license and supply agreement with Pfizer, pursuant to which, it granted Pfizer the exclusive worldwide rights to develop and commercialise taliglucerase alfa for the treatment of Gaucher disease, except for Israel. Protalix retained the right to develop and commercialise taliglucerase alfa in Israel.
Einat Brill Almon, senior vice president of product development of Protalix, said: “This is an important step in our global commercialisation strategy for taliglucerase alfa. We plan to file a marketing authorization application with the European Medicines Agency for taliglucerase alfa in the upcoming months.”