Genzyme Halts Production at Allston Drug Plant After Virus Appears

6/16/09Follow @xconomy

[Updated: 12:45 pm Eastern]

Bad news out of Genzyme this morning. The Cambridge, MA-based biotech company (NASDAQ: GENZ), the world’s largest maker of treatments for rare genetic diseases, said today it is shutting down production at one of its major drug manufacturing plants in Allston, MA after it found a virus that impairs cell growth.

The company says it will halt production to sanitize the Allston Landing facility, and that it expects to be “fully operational” again by the end of July. This interruption will have an impact on patients, because Genzyme makes  enzyme replacement therapies like Cerezyme and Fabryzme at the Allston plant. These drugs, which patients depend on to stay healthy, will now be in short supply globally, the company says. The Cerezyme shortage, is expected to last about a month, and be felt largely during August, said Genzyme senior vice president Geoff McDonough, on a conference call today with analysts. Supply constraints of Fabrazyme are expected to last about six to eight weeks, starting in mid-September, McDonough said. Cerezyme and Fabrazyme are Genzyme’s two best-selling products.

“The patients who need these therapies are our priority,” said Henri Termeer, Genzyme’s chairman and chief executive, in a statement. “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.”

This also can’t be helpful for Genzyme’s effort to boost production of its fastest-growing product, a drug for Pompe disease, which it is attempting to make in larger-scale bioreactors at Allston, to be marketed as Lumizyme. The company failed to win FDA approval of the scaled-up production of that treatment on schedule earlier this year, and it has struggled to meet demand with the version produced in smaller vats (which is marketed under the name Myozyme).

In early March, the company said the FDA sent a warning letter after its inspectors spotted “deficiencies” at the Allston factory during inspections performed in September and October. Genzyme’s senior vice president for global access, Alison Lawton, said the company had responded to all the FDA’s concerns about Lumizyme in its warning letter before the viral contamination was spotted.

The virus Genzyme discovered in one of its six bioreactors at Allston, Vesivirus 2117, has not been shown to cause human infections, the company said. In 2008 the same virus caused a decline in the productivity of the drug-producing Chinese hamster ovary cells at the Allston plant, and at another plant in Geel, Belguim. It was likely introduced through nutrients Genzyme uses to keep the cells alive in bioreactors. Genzyme said is now adding steps to better screen raw materials and improve its virus-removal process.

Shares of Genzyme fell $3.91, or about 7 percent, to $51.71 shortly after the opening bell this morning.

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