Genzyme is at it again. After last month's letter to Fabry patients alerting them that they would not be able to get ample supplies of Fabrazyme, Genzyme is now forced to tell Gaucher's patients that they will need to ration Cerezyme for the treatment of that disease.
This just continues the multi-year saga of being unable to supply ample amounts of either drug consistently due to persistent manufacturing and quality problems -- primarily at its Allston manufacturing facility. Genezyme now appears to be pinning its hopes on the opening of its new Framingham facility in Qtr 1 2012 -- though up to now the Company has not been too reliable with time estimates.
Analysts report that this may be another opportunity for a competitor to come in and steal share (Shire already encroaches on Fabrazyme with its Replagel). Protalix BioTherapeutics is going to the FDA with its taliglucerase to compete with Cerezyme -- and all the quality issues may make the former's case for approval that more compelling.
Posted by Bruce Lehr Sep 16th 2011.