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Tuesday, June 16, 2009

Virus halts production at Genzyme facility

By Julie M. Donnelly

Genzyme Corp. has temporarily halted production at its Allston-based manufacturing facility after the company detected a virus that impairs cell growth in one of the site’s six bioreactors.
Investors turned on the company’s stock shortly after the news was confirmed Tuesday, pushing Genzyme’s (Nasdaq: GENZ) stock down roughly 7 percent to $51.80 a share.

Genzyme is currently working to sanitize the facility and is collaborating with regulatory agencies as it works to resume production. But the company does not expect the plant to be fully operational until the end of July.

The virus is called Vesivirus 2117, and company officials say it has not been shown to cause human infection. However, the virus is known to interfere with the growth of cells used to produce biologic drugs. Genzyme says the virus was likely introduced through a nutrient used in the manufacturing process.

Genzyme has now confirmed that this virus was the cause of declines in cell productivity at two facilities, including the company’s Allston site, in two previous instances in 2008, which were subsequently fully addressed.

Genzyme has previously said that it is currently not making enough of the drugs Cerezyme for Gaucher’s disease and Fabrazyme for Fabry disease, to meet projected global demand. The company is unsure how the virus will affect the Cerezyme production but expects Fabrazyme supply constraints to occur for a limited period beginning in September. The company said it will work with physicians, patients and regulators to minimize the impact of this constraint.

“The patients who need these therapies are our priority,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.”

Genzyme identified the virus at the Allston plant over the weekend and held a conference call with the U.S. Food and Drug Administration Monday.

 

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