Genzyme is expected to pay an up-front disgorgement of past profits of $175m. The company is expected to continue to ship Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), which are manufactured, filled and finished in Allston, as well as Thyrogen (thyrotropin alfa for injection), which is filled and finished at the plant. In the US, distribution of Thyrogen is expected to be based on medical necessity until product filled and finished at another facility is available.
Genzyme added that the FDA has developed a Dear Healthcare Provider letter describing the patients for whom FDA considers Thyrogen to be medically necessary. The letter is expected to be included in shipments of Thyrogen that are filled and finished in Allston.
Additionally, the consent decree requires Genzyme to move fill/finish operations out of the Allston plant for Cerezyme, Fabrazyme and Thyrogen sold within the US by November 28, 2010, and by August 31, 2011 for products sold outside of the US. Genzyme is expected to work closely with regulatory authorities globally with a goal of meeting these deadlines. If Genzyme is not be able to meet these deadlines, the FDA can require the company to disgorge 18.5% of revenue for these products.
Last November, Genzyme has revealed plans to transfer all fill/finish activities from Allston to other locations. Genzyme began to utilise excess capacity at its facility in Waterford, Ireland where it currently fills 80% of Cerezyme supply.
Genzyme received regulatory approval, last week, to fill and finish Myozyme (alglucosidase alfa) produced at the 160l scale at the facility in Waterford and will no longer be conducting fill/finish operations for Myozyme in Allston. In addition, Genzyme has begun the process of transferring all remaining filling activities from Allston to an existing Genzyme contract manufacturer.
Genzyme expects this remediation plan will require approximately 2 – 3 years to complete, with milestones throughout this period. If remediation actions are not complete by these milestones, the FDA can require Genzyme to pay $15,000 per day, per affected drug, until these compliance milestones are met. Once the remediation plan is fully completed, FDA will require five years of oversight and annual reports submitted by Quantic.
Genzyme is currently shipping Cerezyme at approximately 50% of demand and approximately 30% of demand for Fabrazyme.
Henri Termeer, CEO of Genzyme, said: “We continue to make progress both to improve manufacturing and quality systems in Allston and transfer fill/finish activities to other locations, working through the regulatory pathways.
“We appreciate the guidance the FDA provided over the past year as we work to restore the agency’s confidence in our ability to operate the Allston plant at good standards.”
However, the consent decree is subject to approval by the US District Court for the District of Massachusetts.