Genzyme Supply Updates

Information about Today's Press Release (07/22/09)
Posted: 22 Jul 2009 07:50 AM PDT

Today, Genzyme issued our quarterly earnings press release that included information about the current situation with our Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) manufacturing. To read the full press release, please click here.

We wanted to highlight for you a few key points including the following:

• Genzyme has now completed the sanitization of the Allston facility and is on-track to resume production of both drugs there this month. We have taken the initial steps in the cell culture process necessary for the re-start of production of Cerezyme® and Fabrazyme at Allston.


• The treatment guidelines developed with the help of expert physicians, patient group leaders and regulators are being implemented globally to help support doctors and patients in their decisions about product usage during this period, with the goal of conserving supply for the most vulnerable patients.


• We are now determining how much of the remaining work-in-process Cerezyme® material (harvest material that has not yet been purified and put into vials) we will be able to finish production of and release for patient consumption. This material was not yet through the purification process at the time when the Allston plant was shut down. We have decided to discard the material from the end of the affected production run. Additional testing of the remaining material is being conducted and we are continuing discussions with regulatory authorities to determine whether that material may be finished and released, and if so, what portion of the material can be used.


• Genzyme expects new Cerezyme® and Fabrazyme supply from Allston by the end of the year.

This web posting contains forward-looking statements regarding Genzyme's business, including without limitation: the anticipated ability to resume production in the Allston facility and the expected timing thereof and the expected timing of new Cerezyme® and Fabrazyme supply. 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 Cerezyme® and Fabrazyme by the end of July due to concerns from regulatory authorities regarding production at the facility, mechanical failures, additional contamination or any other reason; that that the FDA and/or EMEA does not allow Genzyme to finish and release Cerezyme® materials in progress at the time of the temporary shut-down; 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 posting. These statements speak only as of the date and time set forth in this posting.