Genzyme Says Terms of Plant Decree Finalized
Genzyme on Monday said terms of a consent decree with U.S. regulators over its troubled manufacturing plant in Boston have been finalized, and confirmed it will pay the government $175 million in profits from past sales of drugs.
The biotechnology company said it was still assessing the impact of several factors on its financial forecast for 2010, including its decision to pursue strategic alternatives for three businesses. Genzyme's plant in the Allston neighborhood of Boston was temporarily closed last June following a viral contamination, and the situation has cast a huge shadow over the company.
The closure led to shortages of Cerezyme, the company's treatment for Gaucher disease, and Fabrazyme, its treatment for Fabry disease. Both are rare disorders caused by an enzyme deficiency that can lead to organ damage and death.
The consent decree requires Genzyme to move fill/finish operations out of the plant for Cerezyme, Fabrazyme and another drug, Thyrogen, sold within the United States by Nov. 28. The deadline is Aug. 31, 2011 for products sold outside of the U.S. The consent decree is subject to approval by the U.S. District Court for the District of Massachusetts.
Genzyme said last month it expected to pay $175 million under the consent decree.
