Genzyme Expects FDA Review of Myozyme Factory by Thanksgiving Weekend

9/23/08Follow @xconomy

If Genzyme gets its way, it will be able to start selling larger amounts of Myozyme in the U.S. by the end of this year. The Cambridge, MA-based biotech company (NASDAQ: [[ticker:GENZ]) said it expects the FDA to make a decision on whether to approve supplies of the product (a treatment for Pompe disease) made in a large-scale bioreactor for sale in the U.S. by November 29, the Saturday after Thanksgiving.

The agency will hold an advisory committee on October 21 to vote on whether to approve Myozyme made in a 2,000-liter scale reactor. Supplies of the drug made in a 160-liter reactor were approved in April 2006. The new approval matters for Genzyme because Myozyme is one of the firm’s fastest-growing products, yet supplies have been limited, said company spokesman Bo Piela, at an event yesterday in Framingham, MA.

The constraints on Myozyme have been a thorn in the Genzyme’s side this year. Back in April, the FDA said supplies of the drug made in the two reactors should be considered two different products because of differences in the carbohydrate structure of the drug being produced at the two different scales. That prompted Genzyme to cut its sales forecast for the drug by $45 million, lowering its expected range to between $275 million and $285 million. The product sells for about $300,000 a patient per year.

Genzyme already has approval of Myozyme in 40 countries. It is building an even bigger, 4,000 liter manufacturing plant in Belgium,which it expects will supply patients outside the U.S., he says. “The drug has been growing faster than we expected,” Piela says.

Genzyme also said it expects the FDA to decide whether to approve another drug, Mozobil, by December 16. That treatment is designed to mobilize blood-forming stem cells from the bone marrow so they can be collected, making it more likely that cancer patients will receive a successful transplant. The FDA is expected to decide on a third drug application from the company for Synvisc-One, a treatment for osteoarthritis, by December 23, Genzyme said.

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