Yet another problem at its Allston Landing, MA, plant has disrupted Genzyme's Fabrazyme supply and prompted a re-think of its manufacturing efforts. The news is sure to disappoint Fabry disease patients, who have been on a Fabrazyme rationing program after the company shut down the Allston plant for decontamination almost two years ago.
Genzyme had to scrap one lot of Fabrazyme, a drug that's still running scarce, and warn Fabry disease patients they may have to skip more doses. Meanwhile, because the quality shortfall was traced to the plant's fill/finish suite, Genzyme has decided to give up on that step of Fabrazyme production and turn it over to Hospira instead.
There's some consolation, however: Genzyme says the quality issue won't interfere with its plans to return to full Fabrazyme supply during the second half of this year. That aim hinges on the company's new manufacturing facility in Framingham, MA, which awaits FDA approval.
"This issue only concerned the fill finishing suite," Genzyme spokeswoman Lori Gorski told the Boston Globe. "Production is continuing to go well." And that's something shareholders are intensely interested in: The terms of Sanofi-Aventis' buyout include a $1-per-share payment if Genzyme meets its production goals this year. "We believe we are still able to meet the production milestone defined by the CVR," Gorski told the Wall Street Journal.
ALSO: Shire officials presented data showing that Fabry disease patients and type 1 Gaucher disease patients can safely transition from better known therapeutics from Genzyme to Shire's own treatments for the diseases. Report