Genzyme has to scrap batch of its Fabrazyme drug
Genzyme Corp. today told patients who take its Fabrazyme drug that they may have to delay or miss one or more doses over the next few months because of a new supply disruption at its Allston Landing plant.Workers at the manufacturing facility near the Charles River had to reject a lot of Fabrazyme, a treatment for the rare genetic disorder Fabry disease, because of "environmental monitoring findings," said Genzyme spokeswoman Lori Gorski. Gorski wouldn't say how large the lot was or elaborate on the nature of the findings except to say they showed the Fabrazyme in question did not meet industry standards for good manufacturing procedures.
The supply disruption took place in the plant's fill-finishing suite, during the last stage of production. Employees working in fill-finishing fill vials with drugs, freeze-dry them, cap them, and ship the products to health care providers. Gorski said the disruption did not affect production of Fabrazyme and another biotechnology drug, Cerezyme, which is made in bioreactors in the same plant.
"This issue only concerned the fill finishing suite," Gorski said. "Production is continuing to go well." She noted that Genzyme, headquartered in Cambridge, recently moved fill finishing for Cerezyme from Boston to a company site in Waterford, Ireland, and is in the process of turning over fill-finishing for Fabrazyme and other drugs to an outside contractor.
Genzyme, which had to temporarily shut down the Allston Landing plant in 2009 and ration both Cerezyme and Fabrazyme because of viral contamination in a bioreactor, is close to completing a two-year manufacturing recovery program. Even with the fill-finishing disruption, Gorski said, Genzyme remains on track to return to full Fabrazyme supply by the second half of this year. It already has resumed full shipments of Cerezyme. Both are enzyme replacement drugs that treat patients with diseases caused by enzyme deficiencies.
The company in February reached an agreement to be acquired for $20.1 billion by French pharmaceutical giant Sanofi-Aventis SA, a deal set to be completed next month. Sanofi has said it plans to use Genzyme as its global hub for drugs that treat rare disease.
"Sanofi is certainly aware of this disruption, but they're not actively involved in our operations at this time," Gorski said.
In its notice to Fabrazyme patients today, Genzyme said the timing and extent of reductions in the drug's availability would vary from region to region around the globe. "All regions will share the impact of the reduction in supply," the company said.