It's good news and bad news for Genzyme. The good news is that the company has written patients to say it will boost shipments of its Gaucher disease drug Cerezyme next month, just as it promised back in July. "This is an important milestone in executing on the things we said we were going to do," Genzyme's John Butler tells the Boston Globe.
Genzyme has been struggling to recover from manufacturing problems that forced a shutdown of its Boston-area plant last year. Now operating under an FDA consent decree, the company has had a tough time getting production back up to normal levels. Though inventory of Cerezyme remains thin, Butler says, and production could still be a stop-and-start business, the company is "confident" that it can keep turning out enough of the drug to supply regular dosing for current Gaucher patients in the U.S., Reuters reports.
But Shire just won European approval for its competing Gaucher drug, Vpriv. That's on top of U.S. approval back in February. Genzyme's disrupted manufacturing has obviously created an opportunity for Shire--and other potential competitors--to step into the breach.
Genzyme plans to boost global shipments of Cerezyme later in the year. And in September, it expects to start supplying new Cerezyme patients who've been on a waiting list for the drug. In the meantime, Shire will no doubt be wooing Gaucher patients, trying to entice them onto Vpriv; it's already offering the drug at a price 15 percent lower than Cerezyme's.