Cerezyme production has been bumped up, while initial distributions of Fabrazyme will be lower than expected.
Genzyme reports that all six bioreactors at its Allston Landing, MA, manufacturing facility are up and running. If production continues as planned, the firm anticipates that it will begin meeting patient demand for Cerezyme and Fabrazyme during the first quarter of 2010. Cerezyme is indicated for Gaucher’s disease and Fabrazyme for Fabry disease.
In June the firm was forced to close the plant after finding that a virus had contaminated a bioreactor. The move was expected to set Genzyme back between $100 million and $300 million in revenues. The firm now expects 2009 Cerezyme revenue of approximately $800 million compared with previous guidance that forecasted revenue at the lower end of a $750 million–$1 billion range. Fabrazyme revenue is expected to be approximately $450 million this year compared with previous guidance of $510–$520 million.
Cerezyme production is proceeding with four bioreactors producing bulk material at levels in the higher range of Genzyme’s experience for the product, the company says. It 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. The volume of finished product initially available for release, however, will be lower than anticipated. This is because Fabrazyme bioreactors were restarted later than planned to perform preventive 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 experience.
Also, to ensure global access to Fabrazyme as quickly as possible, Genzyme explains that it has been processing bulk material in smaller batches, which leads to faster availability of final product but also 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.
In June Genzyme determined that its Fabrazyme inventory was sufficient to support approximately 80% of global patient demand through October. Dose-conservation guidelines were implemented by the physician and patient community to help ensure that the reduced product supply was distributed according to clinical guidelines.
Genzyme confirms that it does indeed have enough Fabrazyme inventory to cover 80% of forecasted demand through October. To help ensure the global availability of the remaining Fabrazyme inventory, however, Genzyme will begin shipping enough product to meet approximately 30% of forecasted global patient demand starting October 1 until the end of 2009. Revised clinical guidelines are expected to be formulated.