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Print Edition StoriesThursday, February 19, 2009
Genzyme gets preliminary OK for EU drug production
By Mass High Tech Staff
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Biotech giant Genzyme Corp. reports that it has received a positive opinion from a committee of the European agency in charge of approving its Belgium plant that will be making a drug to treat the rare condition Pompe disease.
According to Genzyme (Nasdaq: GENZ), the Committee for Medicinal Products for Human Use issued the positive opinion regarding the company’s variation to produce Myozyme at the 4000 liter bioreactor scale at its manufacturing facility in Geel, Belgium. Cambridge-based Genzyme reports this is the final step before formal approval to produce and market Myozyme manufactured in the European Union, Norway and Iceland.
The European Commission will make a final decision on the authorization after it receives the committee’s opinion. The Commission, which usually follows the advice of the CHMP, has 44 calendar days to act on the approval.
Late last month, Genzyme reported it would acquire intellectual property rights to some of Exact Sciences Corp.’s (Nasdaq: EXAS) prenatal and reproductive health technologies, and three million shares of Exact’s common stock. Exact will receive $24.5 million in cash; it already has received $16.65 million, and Genzyme will pay an additional $1.85 million over the next 18 months, contingent upon “the non-occurrence of certain events.” Genzyme purchased the shares of Exact’s common stock for an aggregate purchase price of $6 million.
For fiscal 2007, Genzyme reported a profit of $480 million on revenue of $3.8 billion.
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