Genzyme has another supply problem to confess. The rare-disease specialist, acquired by Sanofi ($SNY) earlier this year, said its Cerezyme drug for Gaucher disease would run short beginning next month. A manufacturing snafu and processing changes interfered with production, the company says. The Cerezyme shortage comes just days after Genzyme announced its long-scarce Fabrazyme drug wouldn't ship this month as planned.
In a letter to healthcare providers, Genzyme blamed the new shortage on "a temporary decrease in Cerezyme yields," as well as changes in its "product release processes and procedures." The letter was distributed by the National Gaucher Foundation, a patient advocacy group, the Irish Times reports.
"Changes to Cerezyme availability will be felt globally," the company said. "Delays in shipments will likely affect patients and some adjustments to individual treatment plans may be necessary."
This means a return to rationing, which helped Genzyme spread out supplies of Cerezyme during the extended shortage that began when its Boston-area plant had to shut down because of viral contamination. The company plans to provide only one full dose per month to adult patients instead of two. However, two doses will be given to patients under 19 and those with the most severe disease, the Boston Business Journal reports.
The Cerezyme problem highlights Genzyme's need to get its new manufacturing facility in Framingham, MA, up and running. The company is working with the FDA on the plant and says it expects approval by the first quarter of 2012. Once the new facility is ready to go, Fabrazyme production will move there, the Business Journal reports, and the Allston plant will have the capacity to support expanded Cerezyme production.