Genzyme Corporation (NASDAQ: GENZ) today provided an update on its progress toward restoring production at its Allston Landing manufacturing facility and in implementing temporary supply management measures. The company announced last week that it had interrupted production of Cerezyme^® (imiglucerase for injection) and Fabrazyme^® (agalsidase beta) at the plant to sanitize the facility, after identifying a virus in a bioreactor used for Cerezyme production. The virus impairs the viability of cells used in the manufacturing process and is not known to cause infection in humans.

Following a collaborative interaction with FDA and EMEA, Genzyme has begun shipping product from finished lots of Cerezyme held in inventory, after PCR testing detected no evidence of Vesivirus 2117. Shipments of Fabrazyme were not put on hold.

“We continue to make strong progress toward resolving this situation as quickly as possible, thanks to a broad group of employees across the company who have been working around the clock,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident that the Allston plant will be back online later next month, that we will be able to minimize the impact of constrained supply, and that the measures we are implementing will prevent this issue from occurring again. The support we have received from regulatory authorities, patients, suppliers, and from our industry peers who have shared their experiences and offered expertise and resources, has been heartening.”

Because Cerezyme and Fabrazyme inventories are not sufficient to avoid shortages during the period of suspended production and recovery, Genzyme has begun working with regulatory authorities, physicians and patient organizations to carefully manage product supply, with the goal of protecting the most vulnerable patients. The company met this week with the National Gaucher Foundation’s medical advisory board to formulate clinical guidelines for use by U.S. and other physicians during the period of Cerezyme supply constraint. Genzyme will also convene meetings to facilitate the creation of guidelines for managing Fabrazyme supply. In Europe, following the recommendations of the EMEA, Genzyme will issue a letter to health care providers establishing an approach for the use of Cerezyme and Fabrazyme throughout the European Union during the anticipated period of supply constraint.

At the Allston plant, Genzyme is following a well-established and proven method for removing viruses, which includes disassembly and removal of equipment, cleaning, disinfection of cell culture and downstream production suites with vaporous hydrogen peroxide, installation of new air filters and insulation, and other measures. The disinfection process has begun, and the company remains on track to complete this work and restore operations in all cell culture suites and downstream processing areas by the end of July. Once the sanitization of the plant has concluded, equipment will be reassembled, tested and brought back into operation, and production will resume on a rolling basis. Genzyme will not have to perform process validation runs in order to resume production.

Genzyme continues to evaluate the impact of the interruption in production on the timing and magnitude of constraints on Cerezyme and Fabrazyme supply.