Genzyme shares sink on FDA snag

Genzyme was faced with an unexpected delay for its new therapy to treat Pompe disease after the FDA declined to give the drug its approval. And analysts quickly totted up the damage, noting that the developer could lose six months of marketing time and suffer a decline in expected earnings.

Genzyme had expected an approval for Lumizyme, which is made in 2000-liter batches that can be used to treat adult patients. Genzyme already markets Myozyme for the condition, which is made in smaller batches and reserved for children. Regulators determined that Lumizyme was slightly altered chemically and needed a new name and a new approval. The FDA, though, says it can't approve the therapy until it signs off on the design of a post-marketing trial. And Genzyme and the regulators need to agree on a drug safety program to avoid adverse reactions.

Genzyme says it expects the delay will ding its annual earnings by 12 cents a share, news that sent its stock down close to 10 percent this morning.

"We have made an enormous effort for more than two years to make this product broadly available in the United States, so we are obviously surprised and disappointed by this further delay," said CEO Henri Termeer. "We are confident we will be able to resolve all remaining issues with the FDA within three to six months."

- check out the Genzyme release [1]

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