Genzyme resumes some shipments at Mass. facility

AP News
Posted: Dec 01, 2009 4:53 PM

Genzyme Corp. said Tuesday it has resumed shipping vials of its drug Cerezyme, following a halt related to a plant shutdown for viral contamination.

Cerezyme is a treatment for a rare enzyme disorder called Gaucher disease that can cause liver and neurological problems. Genzyme believes it will be able to meet all worldwide demand for Cerezyme during the first quarter of 2010.

The company is also getting ready to ship new vials of Fabrazyme, a treatment for Fabry disease, but can't yet make enough of the drug to meet the needs of all patients. Fabry disease is an inherited disorder caused by the buildup of a particular type of fat in the body's cells.

Genzyme said the first shipments of Cerezyme will go to the "most vulnerable" patients. By the end of December, Genzyme said it will get the drug to all patients whose treatment had been interrupted. The company said it will be able to meet about 30 percent of the demand for Fabrazyme in the first quarter, and is producing enough to meet about 70 percent of all the demand in the second quarter.

Previously Genzyme said it believed it would be able to meet all expected demand for Cerezyme and Fabrazyme in the first quarter. Genzyme said it will give more details on the supply of Fabrazyme in February.

In June, Genzyme shut down a manufacturing plant in Allston Landing, Mass., to clean up viral contamination. The virus was found in one of the facility's six bioreactors, which are used to create living cells that become part of biotech drugs. While the virus is not harmful to people, it was slowing down the manufacturing of the two drugs.

Separately, the Food and Drug Administration in September said it discovered tiny particles of trash, including bits of steel, rubber and fiber, in vials of Genzyme drugs.

The shutdown cost Genzyme millions in revenue and paved the way for some competitors to win early marketing approval to help deal with shortages of the drugs. The company finished restarting production in September.

In aftermarket trading, Genzyme shares fell 31 cents to $50.80, having closed earlier at $51.11.