FDA delays decision on Genzyme drug

Genzyme Corp., a Cambridge drug maker, said the US Food and Drug Administration has extended its deadline for reviewing Genzyme's application to market a new version of Myozyme, a drug for Pompe disease, manufactured at the company's Boston plant by 90 days until February 28.

The biotech giant already has permission to market Myozyme made at its smaller 160-liter plant in Framingham, but is seeking approval to market the version made at its larger 2000-liter plant in Allston. Pompe disease is a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the United States.

In a press release, Genzyme said it does not expect today's news to affect its 2009 non-GAAP earnings per share, and it reconfirmed its non-GAAP earnings guidance of $4.70 per share for next year.

JP Morgan analyst Geoffrey Meacham, who has a neutral rating on the company shares, said the delay was not unexpected, but reduces the "best case scenario" of FDA approval on November 29. However, Meacham said the press release indicates that the FDA is likely to approve the drug and and eliminates the potential that the agency will require Genzyme to conduct a broad Phase III clinical trial to prove the new version of the drug is safe and effective.

An FDA panel already voted in October to recommend approval of Genzyme's application, provided that a post=approval study is done and other requirements are met, despite some evidence that the Boston version of the drug has some differences than the original version. The FDA generally follows the recommendations of such panels. While making copies of conventional drugs is more straightforward, it is more difficult to duplicate biotech drugs, like Myozyme, that are made from proteins grown in living cells.
(By Todd Wallack, Globe staff)