Genzyme Corporation (NASDAQ: GENZ) today provided an update on its progress to restore supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) for patients worldwide and revised its 2009 revenue guidance for these products. The company is now approximately half-way through the anticipated shortage period for Cerezyme and Fabrazyme, the restart of the Allston Landing manufacturing facility is complete, and if production continues to proceed as planned, Genzyme expects that it can begin meeting anticipated patient demand for both products during the first quarter of 2010.
All six bioreactors at the Allston plant are fully operational and have reached the point in their production cycles when their anticipated output and the timing of product release can be predicted with more certainty. Cerezyme production is proceeding on track, with four bioreactors producing bulk material at levels in the higher range of Genzyme’s historical experience for the product. The company anticipates that newly produced Cerezyme will be available for shipment beginning in November and December as planned.
The first shipments of newly produced Fabrazyme are now expected to occur in mid-December, and the volume of finished product initially available for release will be lower than anticipated. There are several factors that have contributed to the production delay and lower product volume. Fabrazyme bioreactors were re-started later than planned in order to perform preventative maintenance and sanitization procedures related to the decontamination of the facility. In addition, output from the two Fabrazyme bioreactors is expected to be in the lower range of Genzyme’s historical experience for the product. Also, to ensure global access to Fabrazyme as quickly as possible, Genzyme has been processing bulk material in smaller batches, which leads to faster availability of final product but also leads to losses in process efficiency and lower overall volume. As a result, additional product conservation measures are now needed to help ensure that the limited remaining Fabrazyme inventory can be made available to as many patients as possible until new material is available.