Genzyme says that, barring validation and regulatory hiccups, it expects to begin providing Fabry disease sufferers with Fabrazyme produced at its new Framingham, MA, plant beginning the first quarter this year. In fact, in a letter issued in late December, the Sanofi ($SNY) unit said it expected to begin shipments yesterday.
The Framingham plant was still being validated when the Dear Healthcare Provider letter was issued.
"During the course of 2012, the approval of this facility will allow the return to 'normal' supply (that is, no restrictions on dose or patient numbers and a reduced risk of supply disruptions). This return will not be immediate as it will take time to obtain all global regulatory approvals, build inventory and fully return to consistent supply," said a Fabrazyme supply update from October.
For Fabrazyme patients, the supply boost will initially mean that those who received infusions every other week before the drug went into short supply should now expect four doses, at 1 milligram per kilogram, through March.
The letter advised also of particle contamination in vials of the drug filled by a contract manufacturer but has had no reports of adverse events. The letter said Genzyme was then working with the CMO to resolve the matter.
Last March, Genzyme suffered fill/finish troubles with Fabrazyme and with cancer drug Thyrogen. Ending fill/finish operations at its troubled Boston-area plant was a condition in Genzyme's consent decree with the FDA. The company had transferred the operation to another of its facilities and to contractors. Earlier, the drugmaker announced its selection of Hospira ($HSP)—now working on its own remediation effort—for fill and finish of Fabrazyme and Gaucher-disease treatment Cerezyme.
Special Report: Genzyme - Top 12 GMP Violations
Genzyme re-ups and beefs up business with Hospira for fill/finish ops
Hospira finishes for Genzyme
Genzyme shows fight in manufacturing comeback
Genzyme faces FDA intervention at Boston facility