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Genzyme will delay Cerezyme deliveries

Supply limited through Jan.

By Meg Tirrell
Bloomberg News / September 16, 2011

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Sanofi SA’s Genzyme unit will delay shipments from October through January of its top-selling drug, Cerezyme, which treats Gaucher disease, a rare genetic disorder, the company said.

Patients who typically receive a dose of the medicine twice a month will move to once-monthly dosing while Genzyme bolsters supplies, said Lori Gorski, a spokeswoman for the Cambridge-based unit. The National Gaucher Foundation published a letter from Genzyme on its website announcing the delays in shipments of the drug.

Sanofi acquired Genzyme for $20.1 billion in February.

A 2009 virus contamination at Genzyme’s manufacturing plant in Allston led to shortages of Fabrazyme, which treats a rare genetic disorder called Fabry disease, as well as Cerezyme. The shortage reduced revenue and drove the biotechnology company’s shares down. US regulators imposed a remediation plan to address the manufacturing defects, which led to changes in some processes at the plant, Gorski said.

“We’re operating without inventory, so any change in manufacturing plans would have an impact on our supply plans,’’ Gorski said. Genzyme saw reduced output at the beginning of this year because of normal “variabilities in biological manufacturing,’’ she said.

The company expects to have US regulatory approval to start shipping Fabrazyme from a plant in Framingham in the first quarter of next year, Gorski said. That will improve Cerezyme production at the Allston facility, she said.


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