On June 16th, Genzyme communicated that we temporarily suspended manufacturing of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) at our Allston facility in Massachusetts after identifying a viral contamination in a bioreactor used for Cerezyme production. We have sanitized this facility and have resumed full production.
While production at our other manufacturing sites was not affected, the temporary suspension of production at the Allston facility has constrained supply for Cerezyme and Fabrazyme. We know the critical importance of these therapies to patients around the world, and our number one priority is to resume full supply and minimize therapy disruption.
We want to assure you that the virus was not detected in any released lots of Cerezyme, the virus (Vesivirus 2117) has not been detected in the bioreactors specifically used in the production of Fabrazyme at the Allston facility, and the virus has never been shown to cause health problems in humans. The main consequence of the virus was to reduce the amount of enzyme produced by the CHO cells used in our manufacturing processes.
We are working closely with treating physicians, other health care providers, patient communities and regulatory officials worldwide to support patients with Gaucher and Fabry disease during this period of constrained supply.
We are committed to keeping you aware of our progress in overcoming the current supply situation, and encourage you to check back frequently for the latest information. We know that you would like to understand what to expect not just in the near term but also in the long term for your treatment and care. If you would like regular updates sent to your email, please submit your contact information via the “Stay Informed” section on this website. 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 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; Genzyme’s plans regarding management of the supply constraint and its ability to preserve product for the most vulnerable patients; the expected timing for producing new Cerezyme and Fabrazyme at Allston; its plans to increase manufacturing capacity and the expected timing thereof; and its 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 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, mechanical failures, additional contamination or any other reason; that lots of Cerezyme inventory cannot be released because they test positive for the virus or any other reason; 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; 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; Genzyme’s ability to complete capacity expansions and secure regulatory approvals for new capacity in the expected timeframes; 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 June 30, 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 September 30th, 2009
Allston Cleanup Checklist
production stopped
sanitization started
sanitization completed
facility reassembled
production started
Updated as of 7/31/2009
We want to assure you that the virus was not detected in any released lots of Cerezyme, the virus (Vesivirus 2117) has not been detected in the bioreactors specifically used in the production of Fabrazyme at the Allston facility, and the virus has never been shown to cause health problems in humans. The main consequence of the virus was to reduce the amount of enzyme produced by the CHO cells used in our manufacturing processes.
We are working closely with treating physicians, other health care providers, patient communities and regulatory officials worldwide to support patients with Gaucher and Fabry disease during this period of constrained supply.
We are committed to keeping you aware of our progress in overcoming the current supply situation, and encourage you to check back frequently for the latest information. We know that you would like to understand what to expect not just in the near term but also in the long term for your treatment and care. If you would like regular updates sent to your email, please submit your contact information via the “Stay Informed” section on this website. 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 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; Genzyme’s plans regarding management of the supply constraint and its ability to preserve product for the most vulnerable patients; the expected timing for producing new Cerezyme and Fabrazyme at Allston; its plans to increase manufacturing capacity and the expected timing thereof; and its 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 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, mechanical failures, additional contamination or any other reason; that lots of Cerezyme inventory cannot be released because they test positive for the virus or any other reason; 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; 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; Genzyme’s ability to complete capacity expansions and secure regulatory approvals for new capacity in the expected timeframes; 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 June 30, 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 September 30th, 2009
