Genzyme Receives Approval to Market Fabrazyme(TM) in Europe
Genzyme General (Nasdaq: GENZ - news), a division of Genzyme Corporation, announced today that it has received marketing authorization for Fabrazyme(TM) (agalsidase beta) in the European Union. Fabrazyme has been approved for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. There are an estimated 5,000 Fabry patients in Europe. Fabrazyme is currently an investigational product in the United States, where a biologics license application is under review by the Food and Drug Administration. Genzyme will immediately launch Fabrazyme in Europe on a country-by- country basis, as pricing and reimbursement approvals are obtained. Fabrazyme has been sold in France since late last year under a government provision that allowed the therapy to be used and reimbursed before marketing authorization was granted. Genzyme expects to be selling Fabrazyme in the majority of the European Union countries by the end of this year.
In expanding sales of Fabrazyme to these countries, Genzyme will draw on a decade of experience in marketing Cerezyme® (imiglucerase for injection). Fabrazyme will be sold by Genzyme's existing Cerezyme sales force in Europe, which maintains close relationships with physicians who specialize in the treatment of genetic disorders. Genzyme has a substantial and long-standing European commercial infrastructure that includes more than 750 employees in 15 countries.
``We will extend the same unmatched commitment to address the needs of Fabry patients and their physicians as we have to the Cerezyme community for the past decade,'' said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. ``The wealth of experience we have gained over that time in understanding what is required to successfully introduce a therapy of this kind, along with our substantial commercial presence and resources in Europe, leave us well-positioned to make Fabrazyme available as quickly and comprehensively as possible.''
Fabry disease is a genetic disorder in which a deficiency of the metabolic enzyme alpha-galactosidase results in the body's inability to break down certain glycolipids -- primarily globotriaosylceramide (GL-3) -- which then accumulate in cells within the kidneys, heart, skin and other organs, particularly those cells lining the blood vessels. The progressive accumulation of these lipids causes reduced blood flow, leading to kidney failure, stroke, cardiovascular disease, severe pain and numbness. These complications typically lead to death around age 40.
Fabrazyme is a recombinant form of alpha-galactosidase. Genzyme has an exclusive license from Mount Sinai School of Medicine to a broad patent covering the expression of alpha-galactosidase. Genzyme has been scaling up production of Fabrazyme at its Framingham and Allston Landing manufacturing facilities in the United States in preparation for commercial launch.
``We are confident that the clinical story behind Fabrazyme will help support its rapid adoption by European physicians and patients,'' said David Meeker, M.D., Genzyme's senior vice president for therapeutics in Europe. ``The European approval of this product was based on a thorough clinical development program, which included a multi-center Phase 3 trial.''
The results of the Phase 3 trial of Fabrazyme -- the largest ever conducted for Fabry disease -- were recently published in the New England Journal of Medicine. The trial enrolled 58 patients at eight medical centers, including five in Europe.
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