Frequently Asked Questions about Cerezyme® (imiglucerase for injection)
Supply National Gaucher Foundation, USA February 17, 2010

The National Gaucher Foundation has asked Genzyme to provide answers to frequently asked questions about the Cerezyme® supply. For additional information, please feel free to contact Genzyme Medical Information directly at 1‐800‐745‐4447 option 2 or contact your Genzyme case manager.

Why is there less Cerezyme® than Genzyme indicated there would be in December?
According to the Genzyme press release, the delays in availability of Cerezyme® stem from low inventories and the complexity of supplying Cerezyme® to patients in 100 countries combined with the changes Genzyme has made to its manufacturing quality systems, which have led to longer release times for Cerezyme®. In order to minimize the disruptions to patients that such delays can cause and to make supply more predictable, Genzyme currently expects to supply Cerezyme® at a reduced level through the March/April timeframe.

How will this reduced allocation of Cerezyme® help patients?
Genzyme has indicated that they expect by taking this step now, they can build a level of inventory which will allow for a more predictable schedule of Cerezyme® delivery in the coming months and throughout the remainder of 2010.

Is there another viral contamination at Genzyme's facility?
There is no evidence of any type of viral contamination associated with Cerezyme® manufacture since the re‐start of production.

Why couldn't Genzyme better predict these delays?
Forecasting supply and demand is complex and depends on a variety of factors, including predicting how many patients would return to therapy with Cerezyme®, when they would schedule their infusions and at what dose, and the timing of various steps within the manufacturing process. Genzyme expects this plan for management of supply over the next 8 weeks will improve inventory and increase the reliability of Cerezyme® supply to patients.

Why didn't Genzyme communicate this sooner?
Genzyme communicated in December 2009 that as they worked to restart the community on therapy, there would be moments of tight supply and possible brief delays. Additionally, the current reduction in Cerezyme® shipping is intended to improve the reliability and predictability of Cerezyme® supply for patients, physicians, and purchasers in 2010.

See more FAQs at:
http://supplyupdate.genzyme.com/weblog/frequently-asked-questions.html