25 juin 2009
Information sur la situation de Genzyme(Vesivirus 2117)
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Ghislaine SURREL
maladies-lysosomales-subscribe@yahoogroupes.fr
Supply Update Facts
In response to your questions, we'd like to share the following information about Genzyme's supply situation. We will continue to share more information over time. Please refer back to this site or subscribe by email to receive future updates.
Genzyme has identified a virus in a single bioreactor used to manufacture Cerezyme at its Allston facility. This virus, Vesivirus 2117, is not known to cause disease in humans, but it impairs the viability of CHO cells.
We have tested some of the finished vials from affected lots of Cerezyme and the test was negative for Vesivirus 2117. The FDA has authorized us to begin shipping these tested lots of Cerezyme in inventory. We continue to work with the FDA to test additional lots of Cerezyme inventory that have not yet been released, and will provide more information as it becomes available.
Shipments of Fabrazyme are not on hold. This virus has not been detected in the production process for Fabrazyme.
Genzyme has temporarily suspended bulk production of Cerezyme and Fabrazyme in order to sanitize the Allston facility. We expect to restore full operations there in the latter half of July.
Current Cerezyme and Fabrazyme inventories are not sufficient to avoid shortages during this period of suspended production and recovery.
Genzyme continues to evaluate the impact of the interruption in production on the timing and magnitude of constraints on Cerezyme and Fabrazyme supply. The company currently expects the period of constraint for each product to last approximately 6-8 weeks. This period is expected to begin in August for Cerezyme and October for Fabrazyme.
We will carefully manage Cerezyme and Fabrazyme inventories in conjunction with regulatory authorities, patient groups, physicians, and other health care providers, with the goal of protecting the most vulnerable patients.
We believe that inventories will stabilize by the end of 2009.
Myozyme and Aldurazyme are not affected by the current situation.
This web site contains forward-looking statements regarding Genzyme’s business, including without limitation: its assessment of the impact of the Vesivirus on the company, including the duration of the production interruption at its Allston facility, and the expected timing and duration of the Cerezyme and Fabrazyme supply constraint. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: that Genzyme is unable to resume production of Fabrazyme and Cerezyme by the end of July due to its failure to sanitize the facility, concerns from regulatory authorities regarding production at the facility, or any other reason; that lots of inventory being tested cannot be released because they test positive for the virus or any other reason; that the duration of the supply constraint is longer than anticipated; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Form 10-Q for the quarter ended March 31, 2009. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this site. These statements speak only as of the date and time set forth on the site posting in which the statements are made.
06/19/2009 at 08:57 AM | Permalink
http://genzymesupplyupdate.typepad.com/weblog/blog_index.html
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