Genzyme hit by another contamination issue
pharmafile | November 30, 2009 | News story | Manufacturing and Production |Â Â Cerezyme, Contamination, GenzymeÂ
Another manufacturing contamination issue has beset Genzyme, just as it seemed to be overcoming the problems at its Allston Landing facility in the US, sending the company’s shares into a slump.
Genzyme and the US Food and Drug Administration (FDA) notified healthcare professionals on Friday about the potential for contamination, including steel and rubber fragments, in several of the firm’s top products.
Shares in the company dropped around 7% on the news to close the day at $49.28.
Products affected by the contamination could include Cerezyme (imiglucerase), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alpha), Aldurazyme (laronidase) and Thyrogen (thyrotropin alpha), according to an FDA MedWatch announcement.
The news comes just weeks after viral contamination forced Genzyme to shut down a manufacturing facility in Allston Landing, interrupting production of Cerezyme and Fabrazyme and pegging back the company’s third-quarter revenues. One again, the problem seems to have occurred among product filled at the Allston Landing plant.
The company had been forced to set up a rationing system to eke out supplies of the drugs to patients, but said recently it was in ‘recovery mode’ and would resume supplies by the end of the year.
“The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fibre-like material from the manufacturing process and could potentially cause serious adverse events in patients,” said the FDA.
Despite the risk of side effects and the possibility that the contamination might affect the efficacy of the drugs, the agency has decided to allow the products to continue to be marketed, saying it is “acutely aware of the critical need for patients to have continued access to these important products”.
The agency said the notification procedure should prevent contaminated product being administered to patients.
In a statement, Genzyme said about 1% of its products are affected and no adverse reactions in patients have been reported thus far. “The safety profile of these products remains unchanged,” it said.
The FDA noted that it is “actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation”.
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