Genzyme says it will be short of supply with Fabrazyme again due to a lot failure in fill and finish. This continues the problems the manufacturer has had with this product for more than 2 years. Genzyme is still under an FDA consent decree due to its past failures in manufacturing Fabrazyme (and other products) at its troubled Allston facility.
The latest setback will cause the company to change its distribution plan and many patients will need to take less than their normal dose (if they even remember what their normal dose is anymore) or skip a dose. Genzyme says it will still be able to remedy the situation in the second half of 2011 -- is that July 1st or December 31st?
Genzyme's celebrated manufacturing problems in the past lead to shareholder and patient unrest which arguably allowed Sanofi to enter the picture and buy the troubled company. As part of that deal, Sanofi issued contingent value rights (CVRs) based on Genzyme being able to hit certain manufacturing milestones with products like Fabrazyme and Cerezyme, as well as achieving clinical milestones with its late stage product for MS.
A failure to meet the Fabrazyme unit production level of 79,000 units will result in the forfeit of $1 per share CVR. Genzyme says it will still have no problem achievng this milestone. It is expecting its new Framingham plant to come on line later this year but says it can even hit the milestone if Framingham doesn't materialize. In the meantime, Genzyme will shift more of its fill and finish work to its contractor, Hospira, in Europe.
It has to be noted though -- that continued problems like this open the door for Shire to gain more of a foothold for its competitive Fabry's disease product known as Replagel. At present, Replagel is NOT FDA approved and can only be taken [legally] in the US under a special protocol from FDA. Shire however now plans to file with the FDA.
Posted by Bruce Lehr March 26th 2011.