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Cerezyme® (imiglucerase for injection) Supply Update

June 29, 2010 - Genzyme would like to provide an update on Cerezyme® (imiglucerase for injection) availability.

We expect to supply approximately the same amount of Cerezyme in July as we have in each of the past two months, and expect that supply will then increase in the following months. However, there will be regional variations in when Cerezyme will be available, and in some countries patients’ infusion schedules may need to shift due to short-term shipping delays. Whether patients experience shipping delays, and the length and timing of those delays, will depend on where they live and on their particular treatment plan. Therefore, we recommend patients check with their health care providers about infusion schedules. In keeping with the principles we have used during the last year, available Cerezyme will be distributed equitably to all regions and without regard to charitable status.

We have stated in recent communications that our supply of Cerezyme in the coming months could particularly be affected by two factors: the impact of the production disruptions originally reported in April and the effects of preparing to implement the FDA Consent Decree. We can now provide an update on these factors. First, the Allston plant resumed normal operations following the power outage and water system issues we reported in April and Cerezyme production is proceeding successfully. However, our supply of Cerezyme has been reduced due to the impact of those water system problems. Second, preparations for implementation of the Consent Decree are now underway at Allston. As anticipated, as we transition to this new structure, extra steps in our processes have affected the pace of manufacturing and product release. These two factors combined with our low product inventory levels mean that short-term shipping delays should be expected even as we look forward to increasing the overall supply of Cerezyme.

Genzyme staff in each country will be able to provide health care providers with more specific details on Cerezyme availability.

This information gives our best estimate of Cerezyme supply at the current time. Importantly, since we continue to work with extremely limited inventory, even minor changes to our current manufacturing plan can impact availability of Cerezyme.

We appreciate the Gaucher community’s ongoing patience as we work to resume more regular supply of Cerezyme.

This posting contains forwarding-looking statements regarding Genzyme’s business plans with respect to Cerezyme including, without limitation, future supply and the duration, amount and management of the continuing shipping allocations and delays of Cerezyme. These statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, among others, that Genzyme is unable to finish work-in-process material that was in production when operations at Allston were interrupted; that Genzyme’s demand forecasts and estimates are inaccurate; that production of Cerezyme does not continue as planned due to any reason, including bacterial or viral contamination, equipment failures, cell growth at lower than expected levels, fill-finish inefficiencies, power outages or other disruptions of utility services, human error or regulatory issues; that compliance with the Consent Decree, including third-party oversight and/or the implementation of the remediation plan, results in additional or unexpected delays in product releases; 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 Amended Quarterly Report on Form 10-Q/A for the quarter ended March 31, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this posting. These statements speak only as of June 29, 2010 and Genzyme undertakes no obligation to update or revise them.

 

 
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