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EWGGD Cerezyme® Emergency Treatment Program (CETP) - May 2010

This program has been set up for the benefit of patients with type I and III Gaucher disease at high-risk for the development of progressive disease or complications and without access to alternative treatments in Europe, the Middle-East and Eurasia during the period of Cerezyme shortage.  Although the program had stopped in January 2010, it has been reinstated now due to continued shortage of Cerezyme supplies.

The program is conducted by a Board of Advisors consisting of an independent group of physicians, all members of the European Working Group for Gaucher Disease (EWGGD). The Board of Advisors manages the medical and clinical aspects of the program.  Genzyme supports the logistical part of the program: Genzyme provides the product and manages the distribution of product based on decisions of the Board of Advisors.

CETP is not a charitable program. It will run until the stakeholders (EWGGD and Genzyme) conclude that its continuation is no longer necessary.

The program is coordinated by the Academic Medical Centre (AMC), Amsterdam, The Netherlands. In order to enable AMC to do this, Genzyme provides financial support to AMC.

For more information and a applicationform, please click here to download: CETP Protocol & Application Form

Cerezyme Product Update - 22nd April 2010:

Genzyme achieved its goal of building a small inventory buffer during the first quarter. The current shipping allocation of 50 percent of demand will be extended, however, due to an interruption in operations at the company’s Allston facility late in the quarter. The interruption resulted from an unexpected city electrical power failure that compounded issues with the plant’s water system, which have been corrected. The facility is fully operational. Genzyme estimates that it will need to continue the 50 percent shipping allocation for 2-3 months. The company will provide a more precise supply update within a month, after determining whether Cerezyme material that was unfinished when the interruption occurred can be finished, the impact of the pending consent decree on product release timelines and a more accurate assessment of global demand.
Genzyme will continue to work with minimal levels of inventory for Cerezyme and Fabrazyme until the company’s new Framingham manufacturing facility is approved, which is anticipated to take place in late 2011, and any additional manufacturing delays will likely impact supply of these products.
Across the company’s manufacturing operations, programs to expand capacity are on-track. The new Framingham plant is mechanically complete. Pre-operational activities, including cell culture, media preparation, bioreactor validation and staff training, are currently taking place. Engineering and process validation runs are planned for this year. At its Geel, Belgium facility, Genzyme is adding a third bioreactor for the production of Myozyme, and approval is anticipated in mid-2011. The company is also working to transition fill/finish operations out of its Allston facility to its Waterford, Ireland plant and to a contract manufacturer.

Cerezyme - 17th February 2010:

Due to several factors including to improve manufacturing quality systems and perform preventative maintenance and upgrades at the Allston plant, it has been announced that current supply of Cerezyme is less than originally anticipated.

To more consistently manage the resupply of Cerezyme to patients in approximately 100 countries and reduce the interruptions in shipping that occur in the absence of inventory, Genzyme will work to immediately build a small inventory buffer. This buffer will allow a more predictable schedule for Cerezyme delivery through the remainder of 2010 and help avoid the challenges many physicians and patients have experienced in scheduling infusions. To build this inventory buffer, the company will ship 50 percent of demand for an eight-week period beginning the week of February 22, 2010.

Genzyme is working closely with physicians and patient organizations to manage this temporary initiative.

We encourage you to discuss any concerns you may have with your doctor at your treating centre.

Call us on 01453 549231 if you are worried or have any further questions

Cerezyme Shortage 2009: For information on the Cerezyme Shortage 2009 please click here