Genzyme: Allston Fixes To Take Years

Genzyme Corp. expects changes requested by the FDA after a contamination at its Allston plant to take as many as four years longer than previously projected. In May, Genzyme had anticipated repairs would take about two to three years. According to Ron Branning, Genzyme’s senior vice president of global product quality, “The change in the timeline won’t have a material impact on drug supplies.”

In May, Genzyme agreed to pay a $175 million penalty after the FDA found quality issues at the Allston facility. The plant closure reduced supplies of Genzyme’s top drugs, Cerezyme for Gaucher disease, and Fabrazyme for Fabry disease. If changes take longer than outlined in the agreement with the FDA, Genzyme may be required to pay $15,000 a day for each drug involved in any violations.

The company has switched some operations to its facility in Waterford, Ireland, and signed an agreement with Hospira’s One 2 One Contract Manufacturing unit in July for bottle-filling and finishing services for certain medicines.

“We are on track to do the things we’ve said we’re going to do,” said Mr. Branning. “This change in the timing doesn’t reflect anything other than a more thoughtful consideration of how we’re going to complete the remediation plan.”

Sanofi-Aventis recently outlined an offer to acquire Genzyme in a bid rumored to be $21.3 billion. It’s not yet known if this change in the timeline will influence Sanofi’s offer.