Sales of Sanofi's rare-disease drug Fabrazyme have been on an upward trajectory since it got on top of supply issues last year with FDA approval of a new U.S. manufacturing plant. Sales are so good that the French drugmaker will plow another $80 million into expanding production at the Framingham, MA, facility.
Sanofi's ($SNY) Genzyme said it would build a new downstream processing facility for Fabrazyme, which will allow it to purify more of the material harvested from the cell culture manufacturing process. The company handles the fill and finish work for the infusion product at a plant in Waterford, Ireland, that was expanded in 2011 after Genzyme had to close a U.S. plant for remediation.
"Following last year's regulatory approvals of our manufacturing facility in Framingham and a new vial filling line at our plant in Waterford, Ireland, we continue to execute on our global manufacturing strategy, enhancing our capabilities across the entire manufacturing process for Fabrazyme," said Genzyme CEO David Meeker. He said the company's "focus also remains on the future needs of the global Fabry community."
That community was understandably angry with Genzyme when viral contamination required it to close a plant in 2009, setting off a shortage of the drug. There are only an estimated 5,000 people in the world with the rare genetic disease, but many are children who face a painful condition and shortened lifespan. The manufacturing problems undercut Genzyme, paving the way for Sanofi to buy the biotech in 2011. To overcome the supply problems, the company invested in the new plant in Framingham and the expansion in Ireland.
The facility was approved in January 2012, and Fabrazyme sales have rocketed as the drugmaker sold into pent-up demand. Sales last year were €292 million ($395.1 million), up 96.4% when compared in constant currencies, boosting the drugmaker's bottom line in the process. Sales have continued to grow, hitting €91 million ($123.1 million) in the second quarter, boosted further by a decision from Shire ($SHPG) last year not to pursue its own Fabry drug in the U.S.
- here's the announcement