Genzyme created this website in June 2009 as a way to communicate with you about the supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta). As you know, we have faced manufacturing challenges at our facility in Allston Landing, Massachusetts that have reduced the supply of these drugs.
We are focused on returning to a full, reliable supply of our products. Though we have encountered several hurdles, we continue to make progress towards our goal. All of us at Genzyme remain committed to supporting the Gaucher and Fabry patient communities by working closely with treating physicians, other health care providers, patient organizations and regulatory officials around the world during this period of constrained supply.
Please use this website to access the latest information regarding supply of Cerezyme and Fabrazyme. We know that you want to understand what to expect in the coming months so you can plan for your treatment and care. To access the most recent information on Cerezyme or Fabrazyme, please click on the "Cerezyme" and "Fabrazyme" links near the top of this page.
If you would like updates that appear on this site sent to your email, please submit your contact information via the "Stay Informed" section on this website (found on the right side of this page). 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 events on the company’s manufacturing operations and/or ability to supply products; the expected timing and duration of the Cerezyme and Fabrazyme supply constraints; Genzyme’s plans regarding management of the supply constraints, including the anticipated shipping allocations and the expected duration of the shipping allocations; expectations regarding work-in-process material; the anticipated FDA consent decree; Genzyme’s plans to increase manufacturing capacity and the expected timing of regulatory approvals and availability of additional manufacturing capacity; expectations concerning the new working cell bank for Fabrazyme; and Genzyme’s expectations regarding inventory levels and its ability to support demand. 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 the reliability of product supply cannot be established as anticipated; 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, disruptions of services from utilities, or regulatory issues; that Genzyme cannot obtain and maintain regulatory approvals for its manufacturing facilities, including its Allston, Framingham and Geel manufacturing facilities, or for the new working cell bank for Fabrazyme, or that any of those 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 the final outcome of the quality investigation does not support further processing of work-in-process material; 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 third party oversight pursuant to a consent decree may result in delays in the release of products; the number of patients who switch to alternative therapies and the timing of those switches; 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 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 site. These statements speak only as of the date and time set forth on the site posting in which the statements are made.
Updated May 5th, 2010
