European Commission Issues Decision on Taliglucerase Alfa Marketing Authorization Application
NEW YORK and CARMIEL, Israel, Nov. 1, 2012 (GLOBE NEWSWIRE) -- Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX) today 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.
On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement 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.
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Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx(R). Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first approved product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), an enzyme replacement therapy for the treatment of Gaucher disease, was approved for marketing by the U.S. Food and Drug Administration in May 2012 and by Israel's Ministry of Health in September 2012. Additional marketing applications for taliglucerase alfa have been filed in other countries.
Protalix Forward Looking Statement Disclaimer
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties related to the timing of a commercial launch in Israel; decisions by regulatory authorities in various countries regarding whether and when to approve drug applications that have been or may be filed for taliglucerase alfa in such countries as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to the European Commission's decisions not to grant a market authorization for taliglucerase alfa; and risks related to competitive developments. The statements in this release are valid only as of the date hereof and Protalix disclaims any obligation to update this information. These and other risks and uncertainties are detailed under the heading "Risk Factors" in Protalix's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2012.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of November 1, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking statements about taliglucerase alfa (trade name ELELYSO in the United States) that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, decisions by regulatory authorities in various countries regarding whether and when to approve drug applications that have been or may be filed for taliglucerase alfa in such countries as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.