Genzyme's ongoing manufacturing problems certainly vindicate Sanofi's skepticism during merger talks earlier this year. And supply constraints affecting key Genzyme drugs mean Sanofi ($SNY) didn't have to fork over a milestone payment that helped clinch the buyout deal.
But Sanofi would no doubt have preferred to be proven wrong. As it is, the Genzyme unit continues to struggle with production setbacks and disappointed patients. As the Boston Globe reports, Genzyme has had to make procedural changes required by an FDA consent decree. It's been struggling to build inventory of its drugs Cerezyme, for Gaucher disease, and Fabrazyme, for Fabry disease, so it doesn't have enough product on hand to cushion it from supply shocks.
So, when production ran into some productivity problems, the company had to notify patients that their drugs wouldn't be shipping as planned. "You expect variability in biologics manufacturing," spokeswoman Lori Gorski told the newspaper. "But we didn't have the buffer of inventory."
As always, the company holds out the promise of its new plant in Framingham, MA, which is expected to come online next year. "We remain on target with the new Framingham plant, which is pivotal to both products," Gorski said. And the company may get some help on that front: A patient group is lobbying FDA to speed up approval of the new plant. But it's also asking the agency to fast-track some potential competitors for Fabrazyme.
- read the Globe article