21 juin 2009
Keeping you informed
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Ghislaine SURREL
maladies-lysosomales-subscribe@yahoogroupes.fr
For over 25 years, Genzyme has been committed to serving unmet medical needs around the world, with special emphasis on very rare, genetic diseases.
As indicated in our June 16th press release, we have temporarily suspended bulk production at our Allston Landing facility to sanitize the plant because we discovered a virus that impairs cell growth. The virus strain, Vesivirus 2117, has not been shown to cause human infection. We have a plan in place to resolve this issue quickly and expect to return the plant to full operation by the end of July.
Given our current product inventories, we expect periods of constrained supply to occur in August for Cerezyme® (imiglucerase for injection) and starting in September for Fabrazyme® (agalsidase beta). Our priority is to minimize the disruption for patients who rely on these products. Many people across Genzyme are working in a focused way to address this issue, and we have already made great progress in identifying the problem, establishing a plan of action, and getting on with the work.
We take this matter very seriously, and are working closely with regulatory officials, physicians and other heathcare providers, and patient communities worldwide.
In the spirit of transparency and collaboration – values that have guided our company from day 1 - this site has been developed as a way for us to share with you the progress we are making to restore our bulk production to full capacity. We hope that this website will be helpful and encourage you to check back frequently for new information.
Please see below for a message from Geoff McDonough, Genzyme Senior Vice President:
We also want to hear from you. If you have questions or feedback of any kind, please contact us.
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.
http://genzymesupplyupdate.typepad.com/
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