Genzyme : If you are currently treated with Cerezyme® (imiglucerase for injection):

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Ghislaine SURREL

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Information about today’s press release (4/21/10)

This morning, Genzyme released a quarterly earnings statement that includes important information for the Gaucher and Fabry patient communities. To read today’s press release please click here.

We would like to highlight the following information:

The company has recently experienced an interruption in operations at the Allston facility. The interruption resulted from an unexpected city electrical power failure that compounded issues with the plant’s water system, which have been corrected. The plant is now fully operational.

If you are currently treated with Cerezyme® (imiglucerase for injection): The current shipping allocation of 50 percent of demand will be extended due to an interruption in operations at the company’s Allston facility late in the quarter. 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.

If you are currently treated with Fabrazyme® (agalsidase beta): Genzyme estimates that it will need to continue the 30 percent shipping allocation through the third quarter. The company will provide a more precise update within a month once additional information is available about the productivity of the new Working Cell Bank (WCB), as well as the timing of regulatory clearance of the new WCB, the impact of the pending consent decree on product release timelines and whether Genzyme is able to finish the small amount of work-in-process Fabrazyme material that was unfinished when the interruption occurred at the Allston plant.

We recognize that this situation presents additional challenges to both the Fabry and Gaucher disease communities. We would like to point out that despite this temporary interruption, at this time the Allston facility is fully operational and production is continuing. While we strive to improve operations at our Allston manufacturing facility, it is important to note that our ability to supply Cerezyme and Fabrazyme remains vulnerable to any additional manufacturing delays given our continued minimal product inventories.

Additional information will be posted on this site when it is available. In the meantime, Genzyme will be working with treating physicians and patient communities to best manage through this extended period.

This posting contains forwarding-looking statements regarding Genzyme’s financial outlook and business plans including, without limitation: expectations regarding the supply constraints for Cerezyme and Fabrazyme; plans to manage inventories of Cerezyme and Fabrazyme during the supply constraints, including the anticipated shipping allocations and the expected duration of the shipping allocations; the factors that will be considered to set expectations regarding supply for Cerezyme and Fabrazyme and the expected timing of those assessments; expectations concerning the work-in-process material; the anticipated FDA consent decree; and the potential approval of the new working cell bank for Fabrazyme. These statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, among others: that the reliability of product supply cannot be established as anticipated; that the allocations of Fabrazyme and Cerezyme need to last longer than expected or need to be more severe than expected for any reason, including that Genzyme is unable to finish work-in-process material that was in production when operations at Allston were interrupted, that production of Cerezyme and/or Fabrazyme does not continue as planned due to any reason, including without limitation bacterial or viral contamination, mechanical failures, cell growth at lower than expected levels, fill-finish inefficiencies, or regulatory issues; that productivity of the new Fabrazyme working cell bank does not increase as anticipated; that Genzyme cannot obtain regulatory approvals the new working cell bank for Fabrazyme, or that such approvals are delayed for any reason; that the length or extent of one or a series of additional production delays or disruptions deplete inventories of Cerezyme and/or Fabrazyme; that Genzyme may be unable to reach agreement with the FDA on the terms of a consent decree and that the terms of such a consent decree may differ from Genzyme's current expectations; that the negotiations with the FDA around the consent decree take longer than anticipated; that third party oversight pursuant to a consent decree may result in delays in the release of product; that the company’s product demand forecasts and estimates are inaccurate; 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 Annual Report on Form 10-K for the year ended December 31, 2009. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this posting. These statements speak only as of the date of this posting and Genzyme undertakes no obligation to update or revise them.

http://supplyupdate.genzyme.com/weblog/2010/04/information-about-todays-press-release-42110.html

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