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Blow for Genzyme as FDA finds fault with Allston facility

Published on 13/03/09 at 01:34pm

The chances of approval for Genzyme's new Pompe disease drug Lumizyme have diminished dramatically after the US Food and Drug Administration uncovered what it described as "significant objectionable conditions" at the firm's Allston manufacturing plant.

Worryingly for Genzyme, the problems laid out in an FDA warning letter were not confined to Lumizyme (alglucosidase alfa). They also threaten the continued supply of Genzyme's already-marketed products Fabrazyme (agalsidase beta) for Fabry disease and Cerezyme (imigucerase) for Gaucher disease.

The firm said, however, that it does not expect any disruptions to the availability of these products as a result of the February 27 letter. Fabrazyme added $494 million to Genzyme's coffers in 2008 - or 11% of its total revenue - while Cerezyme is Genzyme's top-selling product with 2008 sales of $1.2 billion (27% of total).

Just a few weeks back Pharmafocus that Genzyme was optimistic that approval to manufacture Lumizyme - sold as Myozyme outside the USA - would be forthcoming by the end of February.

Earlier, the agency ruled that production of the active ingredient at Allston was so different to production of Myozyme at Genzyme's other manufacturing plants that the company had to file separately for approval of the drug under a different brand name.

FDA investigators inspected the plant from in September and October last year and documented what the letter describes as "significant deviations from current good manufacturing practice".

These included problems with procedures designed to prevent microbial contamination, manufacturing of bulk drug substances, maintenance of production equipment and the maintenance of computer systems.

Genzyme filed written responses to these GMP violations in October 2008 and February 2009, but the FDA said it still has outstanding concerns that need to be addressed.

The letter makes no mention of another product - BioMarin Pharmaceuticals' Aldurazyme (laronidase) for mucopolysaccharidosis type I - that is also made by Genzyme at the Allston plant.

Myozyme had sales of $300 million last year, and in late February Genzyme won approval in Europe for a new production facility for the drug based in Geel, Belgium.

That clearance was essential to overcome supply shortages in Europe. The EU authorities recently recommended that children and adolescents be given priority access to Myozyme in order to make available stocks last longer.

Related stories:

Genzyme says new plant approval is imminent

Wednesday, February 18, 2009

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