Genzyme meets first milestones of FDA consent decree

US biotech major Genzyme (NASDAQ: GENZ) said yesterday that it has ended fill/finish operations within its Allston, Massachusetts, plant for products sold in the USA, as required by the Food and Drug Administration consent decree deadline of November 28.

Genzyme signed a consent decree with the FDA earlier this year, agreeing to correct manufacturing quality violations at its Allston facility and to turn over to the federal government $175 million in “unlawful profits” from the sale of products that were made at the plant. Had Genzyme not be able to meet these deadlines, the agency could require the company to disgorge 18.5% of revenue for these products (The Pharma Letter May 25).

The company now says that all fill/finish activities for its rare disease drugs Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta) and Thyrogen (thyrotropin alfa for injection) for the US market take place at Genzyme’s Waterford, Ireland, plant, and at an external contract manufacturer. With this move, all previous restrictions on the marketing and distribution of Thyrogen within the USA have been lifted.