(By Balaseshan) Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics Inc. (NYSEAMEX:PLX) said the European Medicines Agency (EMA) has adopted an opinion on marketing authorization application of taliglucerase alfa to treat Gaucher disease.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted an opinion recommending against the Marketing Authorization of taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease.
As part of its opinion, the CHMP gave a positive risk-benefit assessment for taliglucerase alfa 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 Committee could not recommend Marketing Authorization due to Shire Plc's (NASDAQ:SHPGY) velaglucerase alfa, which received prior Marketing Authorization with orphan drug designation for the same condition.
Therefore, Shire's treatment has orphan market exclusivity in the European Union (EU) for ten years from the time of its authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors. This request, however, was denied.
Pfizer and Protalix are dedicated to the treatment of Gaucher disease worldwide and continue to move forward with other global regulatory filings for taliglucerase alfa.
Taliglucerase alfa (ELELYSO) was approved by the U.S. Food and Drug Administration on May 1, 2012 for the long term enzyme replacement therapy (ERT) of adults with a confirmed diagnosis of Type 1 Gaucher disease.
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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