Genzyme Garners FDA Panel's Nod

Last April, U.S. regulators decided that Myozyme made in a 2,000-liter plant was different than the one currently made at the 160-liter plant, and as a result, said they would require a separate biologics license application supported by a clinical trial.

Genzyme is currently providing the drug out of the 2,000-liter facility for free to about 160 patients through a compassionate use program, which is costing the company roughly $140,000 per patient each year, according to Deutsche Bank analyst Mark Schoenebaum.

Upon approval, the drug produced at the larger-scale plant will be commercially available to the patients enrolled in the program.

The number of patients in the program, however, has already brought the new larger-scale facility to full capacity, according to Schoenebaum. Thus, he says that even with approval of the facility, patients who are not receiving the drug through the program will have to wait for approval of a 4,000-liter plant in Europe, which is expected in the first half of 2009.

Genzyme is set to report its third-quarter earnings Wednesday morning, followed by Amgen(AMGN Quote) after the market closes and Celgene(CELG Quote) on Thursday.