25 juin 2009
Informations sur l'approbation de la Cerezyme (Vesivirus 2117)
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Ghislaine SURREL
maladies-lysosomales-subscribe@yahoogroupes.fr
06/19/2009
Information about FDA approval of some inventory of Cerezyme® (imiglucerase for injection) on Wednesday, June 17, 2009
We would like to share more information with you about the recent decision by the FDA to allow us to resume shipments of Cerezyme® (imiglucerase for injection) from our Allston facility.
On Tuesday, June 16, Genzyme explained in a conference call with the business community that some batches of Cerezyme at the Allston facility were being tested for the presence of Vesivirus 2117, using a technique called polymerase chain reaction (or PCR). No evidence of the virus was detected. We provided this information to the FDA on the morning of Wednesday, June 17. Based on their review of this information, the FDA subsequently authorized Genzyme to begin shipping these tested lots of Cerezyme in inventory that have completed testing. We continue to work with the FDA to test additional lots of Cerezyme inventory that have not yet been released.
However, even with the release of this inventory as a result of the authorization from the FDA, Genzyme still anticipates a supply constraint for Cerezyme starting during the August timeframe. We will carefully manage inventories of Cerezyme in conjunction with regulatory authorities, patient groups, physicians, and other health care providers, with the goal of protecting the most vulnerable patients.
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 04:18 PM | Permalink
http://genzymesupplyupdate.typepad.com/weblog/blog_index.html
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