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Pfizer (PFE),Protalix (PLX) Report Taliglucerase Alfa Denied Marketing Approval by EC

November 1, 2012 11:04 AM EDT
Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (AMEX: PLX) announced that the European Commission (EC) has issued a Commission Decision refusing the Marketing Authorization for taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease. The EC has endorsed the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) recommendation not to issue a Marketing Authorization for taliglucerase alfa in the European Union. 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.

As first disclosed on June 22, 2012, the CHMP issued its Opinion on taliglucerase alfa and gave a positive risk-benefit assessment concluding that the benefits of the medicine outweighed its risks in the treatment of Type 1 Gaucher disease. Despite the positive risk-benefit assessment, the CHMP could not recommend Marketing Authorization due to the fact that Shire plc (Shire)'s velaglucerase alfa had received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the EU for a ten-year period commencing on its authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors but the request was denied.

"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."

Pfizer and Protalix are dedicated to the treatment of Gaucher disease and continue to move forward with regulatory filings in other countries for taliglucerase alfa. Taliglucerase alfa (ELELYSO™) 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.


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