(By Balachander) Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics Inc. (NYSEAMEX: PLX) said the European Commission (EC) has refused the marketing authorization for taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease.
The EC has backed a recommendation from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) not to issue a marketing authorization for taliglucerase alfa in the European Union.
"We are disappointed by the EC's decision on taliglucerase alfa and believe it is important, given the history of past shortages, for the Gaucher disease community in the EU to have a third treatment option available," said Diem Nguyen, General Manager, Pfizer Biosimilars. "We will continue to work closely with our partner, Protalix, to make taliglucerase alfa available to the Gaucher disease community in other countries."
[Related -Pfizer Inc. (PFE) Q3 Earnings Preview: What To Watch?]
The CHMP recommendation was not related to the safety, quality or efficacy of taliglucerase alfa, but solely to the specific requirements of the European Union (EU) Orphan Drug Regulation, the companies noted.
Taliglucerase alfa was approved by the U.S. Food and Drug Administration in May 2012 for the long-term enzyme replacement therapy (ERT) of adults with a confirmed diagnosis of Type 1 Gaucher disease and was approved by Israel's Ministry of Health in September 2012.
[Related -Six Stocks That Could Get An October Bump From The FDA]
In November 2009, Pfizer and Israel-based Protalix agreed to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel.