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Genzyme Corp. announced today that it has begun shipping newly produced vials of its drug for Gaucher disease, Cerezyme. The supply has been interrupted since the plant was closed for six weeks over the summer, following the discovery of a virus at the plant. Some patients have had to forego doses during the shortage.
Cerezyme is the only FDA approved drug to treat the rare genetic disease, although regulatory agencies around the world have recently allowed a drug target made by UK-based Shire plc to be prescribed prior to approval.
The initial Cerezyme shipments will not resolve the shortage completely, but Genzyme officials say the most vulnerable patients will be assured uninterrupted treatment. By the end of this month, Genzyme will expand shipments of Cerezyme to patients worldwide who have experienced interruptions in their treatment this year.
The company expects that it can meet anticipated worldwide demand during the first quarter of next year.
Genzyme is also preparing to ship new vials of its treatment for Fabry disease, Fabrazyme, from the Allston plant. But the company is reporting that the production levels are lower than expected and the plant is currently producing Fabrazyme at a rate of approximately 70 percent of anticipated demand for 2010. Genzyme officials say they are intensively working to improve the productivity of Fabrazyme manufacturing.
Genzyme will continue to ship 30 percent of Fabrazyme demand during the first quarter of 2010 to ensure continued treatment for all patients and to build inventory to begin shipping 70-100 percent of demand in the second quarter.
“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 A. Termeer, Genzyme’s chairman and chief executive officer, in a statement.
Both Gaucher and Fabry diseases affect fewer than 10,000 patients worldwide.
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