Update regarding Cerezyme (imiglucerase for injection) manufacturing (3/12/10)

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Ghislaine SURREL

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Update regarding Cerezyme (imiglucerase for injection) manufacturing (3/12/10)

Posted: 12 Mar 2010 11:34 AM PST

In our effort to maintain openness and transparency in our communications during this time of supply challenge, we would like to provide the Gaucher community an update regarding Cerezyme.

In December, during our routine quality control process of products filled at our Waterford, Ireland facility, an impurity was identified in one vial of Cerezyme. Genzyme’s subsequent testing confirmed that the source of the impurity was tubing used during the fill/finish process. As part of our corrective actions, we have introduced a different type of tubing into our filling operation at Waterford.

This impurity may have been present at very low levels in a very small percentage of Cerezyme vials (less than 1%). It has not been associated with any adverse effects in human beings and the level detected in the Cerezyme vial was 40,000 times lower than levels reported to cause harm in mice. Based on review of the medical literature and the Cerezyme safety database, any risk to patients from this impurity is considered to be remote. The Cerezyme batch in question meets all routine quality release standards and therefore has been released for use. The overall safety profile of Cerezyme remains unchanged.

As part of our standard Good Manufacturing Practice (GMP) process, Genzyme reported this finding to relevant health authorities, including FDA and EMA, in early February, 2010. The health regulatory agency in Australia, the Therapeutic Goods Administration (TGA), has asked Genzyme to notify physicians and patient group leaders within Australia of this finding. Although there are currently no plans to issue such letters outside of Australia, we understand that this information has the potential to raise questions and concerns. Therefore we wanted to be sure that we informed the global Gaucher community accordingly.

The safety of our products remains our top priority. Any patient or physician who has questions or concerns about the use of our products should contact Genzyme Medical Information or your local Genzyme representative.

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