Genzyme Corporation (Cambridge, MA) has begun shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at its plant in Allston Landing, MA. The plant had been closed for several months because of bioreactor contamination with Vesivirus that was discovered in June. Cerezyme is used to treat Gaucher disease, a genetic condition affecting fewer than 10,000 people worldwide.
Genzyme is also preparing to ship vials of newly produced Fabrazyme (agalsidase beta) from the Allston plant. The first two bioreactor runs of Fabrazyme have completed their production cycles, and the output from these runs has been lower than normal. The company is currently producing Fabrazyme at a rate of approximately 70% of anticipated demand for 2010.
Genzyme will continue to ship 30% of Fabrazyme demand during the first quarter of 2010 to ensure continued treatment for all patients and to build inventory to begin shipping 70—100% of demand in the second quarter. The range and timing of shipments depends on restarting fill/finish operations for Fabrazyme at the Allston facility and on restoring the overall productivity of Fabrazyme manufacturing.
Coming on the heels of this announcement was the news that Pfizer is licensing a Gaucher treatment from Israeli-based Protalix Biotherapeutics. The Protalix drug, prGCD, had received approval from the US Food and Drug Administration on August 17 to proceed with a treatment protocol. The treatment protocol allows physicians to treat patients of Gaucher disease with prGCD in the US and additional countries while studies of prGCD continue as part of the company's ongoing pivotal Phase 3 clinical trial. The FDA had asked Protalix to submit the treatment protocol to address the shortage of Genzyme's Cerezyme, which was, at the time, the only approved treatment for Gaucher disease.
The FDA has since granted priority review for Shire plc's (Cambridge, MA) NDA for velaglucerase alfa, another drug being developed to treat Type 1 Gaucher disease.