Genzyme

Genzyme resumes Cerezyme supplies

pharmafile | December 3, 2009 | News story | Manufacturing and Production Cerezyme 

Genzyme has begun shipping newly produced Cerezyme manufactured at its Allston Landing plant for the first time after it was closed down because of safety problems.

A viral contamination forced the company to shut down the facility in June, with further safety issues delaying its return to production.

The plant manufactures Cerezyme for Gaucher disease and Fabrazyme for Fabry disease, which replace vital enzymes in patients who have a deficiency in producing themselves.

The shutdown immediately hit supplies of the drugs and have badly dented the company’s sales. Rival company Shire has also seized on the opportunity to try to muscle in on the market, and is awaiting clearance to market its own product, velaglucerase alfa.

Despite resuming shipments, production at Genzyme’s site is still not up to full capacity. This means the company will have to continue to ration supplies of the Cerezyme and Fabrazyme, and only expects to restore full production of the products by the first and second quarters respectively in 2010.

“Shipping the first new product manufactured in Allston is a critical milestone in our effort to again fully meet the needs of patients with Gaucher and Fabry disease around the world,” said Henri Termeer, Genzyme’s chairman and chief executive.

“We continue to work in a very intense and comprehensive way to build a world-class manufacturing programme and to ensure continuous supply of these products in the future.”

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