25 juin 2009
Comment la situation a été gérée (Vesivirus 2117)
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Ghislaine SURREL
maladies-lysosomales-subscribe@yahoogroupes.fr
How is the supply situation managed?
We recognize that access to treatment is a top concern for physicians, other health care providers, patients and their families during this temporary period of Cerezyme (Imiglucerase) and Fabrazyme (Agalsidase beta) supply constraints. It is our top priority as well. During this time period, we are committed to approaching access in a thoughtful, fair, and transparent manner according to these guiding principles for the allocation of the existing supply of Cerezyme and Fabrazyme:
Genzyme will work within the framework set by the regulatory authorities, to facilitate a consultation with expert clinicians and patient group leaders in order to implement the recommendations with the goal of preserving enough supply for the most vulnerable patients. To do this, the recommendations will ask a larger group of patients to conserve supply by missing or reducing doses for a temporary period, beginning as soon as possible.
The decision to conserve supply in this way ultimately lies with each individual patient and their physician. Genzyme cannot determine this treatment allocation on an individual basis.
Genzyme plans to manage the supply constraint during this period on a global basis – with all countries and regions contributing fairly, and without reference to commercial or charitable status.
We believe that working together as a community will help allow us to manage through this period of tight supply in the best way possible.
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, the expected timing and duration of the Cerezyme and Fabrazyme supply constraint, and Genzyme’s plans regarding management of the supply constraint and its ability to preserve product for the most vulnerable patients. 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 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; whether the needed number of patients and their physicians cooperate with the recommendations made in order to conserve supply and how quickly people begin conserving product; the receipt of regulatory consents, if and to the extent required, for the recommendations made to conserve supply; the accuracy of Genzyme’s product demand estimates; 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.
06/23/2009 at 02:38 PM | Permalink
http://genzymesupplyupdate.typepad.com/weblog/blog_index.html
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