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Cerezyme production faces further delay

Genzyme will discard about 80 per cent of the remaining material being used to manufacture Cerezyme following the discovery of a virus at its Allston plant

Biotechnology company Genzyme will discard about 80 per cent of the remaining material being used to manufacture Cerezyme (imiglucerase) following the discovery in June of a virus at its Allston plant.

The decision was made to minimise risk and ensure that a new supply of the drug can be made ready by the end of the year. It will result in a further write off of $8.4m in addition the $14.2m already reported for the second quarter.

Henri Termeer, CEO of Genzyme said in a statement: "In the end, we could not take the risk of processing material that has any possibility of re-contaminating the plant and setting back our ability to supply Cerezyme to patients. Now that we have resumed production, we are focused on the road to recovery."

While the drug is in short supply, the company has restricted shipping in the US to those 18 years or younger with Gaucher disease type 1 and those with Gaucher disease types 2 and 3. This move will ensure that the most vulnerable patients continue to be treated. Doctors may also apply for emergency access to Cerezyme for patients in life-threatening situations. Outside the US the company is in discussions with regulatory authorities, doctors and patient organisations to determine how to manage supply.

Additional viral monitoring procedures have been introduced at the Boston-based plant and supply is expected to get back to normal levels in late November and December with the release of newly produced product.

11th August 2009

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