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The use of taliglucerase alfa has been accelerated by a deal between Pfizer and Protalix BioTherapeutics.
Pfizer will receive exclusive worldwide licensing rights, while developer Protalix will retain the exclusive marketing rights in Israel.
Taliglucerase is an enzyme-replacement therapy produced from genetically-modified carrots, and a rolling new drug application (NDA) is now with the US Food and Drug Administration (FDA).
The FDA has granted orphan-drug and fast-track status, which expedite the review of drugs to treat rare conditions or diseases, as well as an emergency-use authorisation.
The FDA has already approved expanded access program (EAP) treatment, and taliglucerase is being provided to Gaucher’s patients in the US and the European Union.
Says Protalix chief executive Dr David Aviezer; “By joining our advances in biologics manufacturing and protein development with Pfizer’s global strengths in patient services and reimbursement, we expect to help make taliglucerase alfa an important and cost-effective treatment choice for Gaucher’s patients throughout the world.”
Copyright Press Association 2009