Genzyme's new plant nabs approval from EMA

Sanofi ($SNY) is looking forward to ending long-running supply problems at Genzyme. The company said Genzyme's new manufacturing plant in Framingham, MA, won approval from European regulators to produce Fabrazyme—which means Fabry disease patients will soon be on their way to full access to their treatments. The plant still awaits approval from the FDA.

The shortage won't be cured immediately, Sanofi was quick to point out, because the plant needs global regulatory approvals, not to mention time to ramp up production. But after two years of scarce treatments, the EMA's approval is a light at the end of the tunnel.

Calling the development "an important milestone in our manufacturing recovery," Genzyme CEO David Meeker said, "Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme and working toward all regulatory approvals of our Framingham plant are our highest priorities."

Genzyme's supply issues angered Fabry disease patients and turned off investors, as competitors such as Shire moved in with competing products, some approved on an emergency basis because of the Genzyme shortages. Since Sanofi bought the company last year, it has been promising a return to normal supply levels, but faced a number of setbacks along the way. Genzyme ended up failing to meet supply targets required for the first milestone payment specified as part of the Sanofi buyout deal.

- read the release from Genzyme
- see the Boston Globe story
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