Genzyme expects FDA ruling on Myozyme

Genzyme Corp., a Cambridge biotechnology company, said today that it expects to know by Nov. 29 if regulators approve or reject its plans to increase production of the drug Myozyme.

In October, a Food and Drug Administration panel will discuss Genzyme's plans to manufacture Myozyme in a 2,000-liter bioreactor. The company said it expects a ruling from the FDA itself by the end of the following month.

A bioreactor is a vessel in that carries out various chemical or biological processes. Biotech drugs are typically manufactured using living cells.

Myozyme has received FDA approval as a treatment for the genetic disorder Pompe disease, which causes muscle impairment. The drug is currently made in 160-liter bioreactors, and Genzyme wants to manufacture is in larger reactors to increase production.

In April, the FDA said it will treat the 2,000-liter application as if it were a request for an entirely new drug.

Genzyme also said it expects rulings from the agency on two other drug candidates, Mozobil and Synvisc-One, before the end of 2008.

Genzyme also said the agency granted its request for a priority review of Mozobil, meaning it will complete the review in six months instead of the usual 10 months. The company expects a ruling by Dec. 16, and it expects a ruling on Synvisc-One by Dec. 23. The agency can either approve or reject the application, or request more information from the company.

Mozobil is designed to increase the production of stem cells in bone marrow so those cells can be harvested for transplant. Synvisc-One is intended to treat ostheoarthritis of the knee, and combines three older drugs into a single injection. The drug is on sale in Europe and Canada.

In afternoon trading on the Nasdaq Stock Market, Genzyme shares declined 33 cents to $76.51. (AP)