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Genzyme's woes are a boost for Shire and Protalix

Published on 09/07/09 at 11:00am

The contamination problems at a plant used by Genzyme to manufacture a drug for Gaucher disease have prompted the US Food and Drug Administration to accelerate access to rival products from Shire and Protalix.

The FDA has asked Shire and Protalix to file treatment protocols for their Gaucher treatments, which would allow physicians to use the drugs to treat patients with the disorder ahead of approval and launch in the US.

Gaucher disease results from a deficiency of the enzyme glucocerebrosidase in the body, caused by a genetic mutation received from both parents. The disease course is quite variable, ranging from no outward symptoms to severe disability and death.

Genzyme was forced to close down production of its Gaucher treatment Cerezyme (imiglucerase for injection) at its Allston Landing facility after identifying a virus in a bioreactor used to make the drug. Cerezyme sales run at around $300 million a quarter and it is used by the majority of Gaucher patients.

The company has been forced to disassemble and remove equipment at the plant, disinfect using vaporous hydrogen peroxide and replace air filters and insulation. In its last statement on the issue Genzyme said it expects supply constraints for 6-8 weeks starting from the beginning of August.

That provides an opportunity for Shire and Protalix to get some early exposure for their products in the US market.

Shire has already filed the treatment protocol for its drug candidate, velaglucerase alfa, and said it would provide the drug free of charge initially, in order to provide access to patients as quickly as possible. The company said it has sufficient supply of velaglucerase alfa to meet anticipated patient demand and is working with the FDA to file velaglucerase alfa for approval as early as possible.

Protalix said it was discussing the proposed treatment protocol for its own candidate, prGCD, with the FDA. It hopes to submit it as a supplement to its current Investigational New Drug application for the therapy.

Meanwhile, Genzyme has mobilised all its available supplies after testing that they were not contaminated with the virus - known as Vesivirus 2117 - but has conceded that inventories are not sufficient to avoid shortages before it can restart production.

The virus was probably introduced through a raw material used in the manufacturing process, according to Genzyme and it is working with its suppliers to guard against a recurrence of the issue.

The firm said it would also consult with other companies on the contamination in order to draw up industry-wide recommendations on how to prevent and deal with such a scenario. That effort will include developing an assay for Vesivirus 2117.

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