In a badly needed win, Genzyme announced this morning that the FDA has approved Lumizyme for the treatment of Pompe disease. And the big biotech's stock bounced up six percent on the news, which was a big relief for investors who fretted that the FDA would hold back on any approval until after it resolved its many manufacturing woes.
Just yesterday afternoon the FDA formally finalized the terms of the decree regarding Genzyme's trouble Allston, MA-based manufacturing facility. Genzyme will return $175 million in past profits from the sale of tainted drugs. The company will continue to ship Cerezyme, Fabrazyme and Thyrogen. But the company must move fill/finish operations of all U.S.-sold treatments out of the Allston plant November 28, 2010, and by August 31, 2011 for products sold outside of the United States. If the drugmaker doesn't comply, the FDA will require the company to disgorge 18.5 percent of revenue from sales of the products.
Genzyme began transferring drug manufacturing out of the Allston plant last year. Its facility in Waterford, Ireland currently handles 80 percent of Cerezyme supply, and has received FDA approval to begin Myozyme fill/finish activities. A contract manufacturer will take on additional work that would have been done at the Allston plant. Genzyme is currently shipping Cerezyme at approximately 50 percent of demand and Fabrazyme at 30 percent.
As for the fate of the Allston plant, Genzyme, along with third-party consultant Quantic, has drafted a remediation plan to the FDA. The drugmaker expects the plan to require two to three years to complete. Once finished, FDA will require five years of oversight and annual reports submitted by Quantic.
"We continue to make significant progress both to improve manufacturing and quality systems in Allston and transfer fill/finish activities to other locations, working as expeditiously as possible through the regulatory pathways globally," said Genzyme's CEO Henri Termeer.
- here's the Reuters story on the approval
- here's Genzyme's release