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FDA Panel Backs Drug From Firm to Be Acquired By Genzyme

Posted on: Thursday, 2 December 2004, 12:00 CST

Dec. 2--Genzyme Corp.'s not-yet-completed $1 billion acquisition of Ilex Oncology Inc. appeared to pay off yesterday when an advisory committee to the Food and Drug Administration recommended the agency approve Ilex's experimental cancer treatment for children with certain types of leukemia.

The agency is expected to rule on the drug, to be known as Clolar, this month.

The committee urged Clolar be approved to treat cancer patients under age 21 with acute lymphoblastic leukemia who haven't responded to existing treatments, or whose cancers have returned after treatment.

But it also recommended Ilex conduct additional clinical studies before the drug be approved to treat another disease, acute myeloid leukemia.

Under the recommended approval, Clolar would not become a "front-line" treatment for the disease. But it would give doctors an alternative where none exists today for patients with particularly bleak outlooks. Genzyme said that if approved, Clolar would be the first new treatment for pediatric cancer approved in about a decade.

"All the progress we've made in childhood leukemias over the past 30 years was done with drugs that were developed and approved in the 1960s and '70s," said Dr. Stephen Sallan, chief of staff at Dana-Farber Cancer Institute in Boston and a paid consultant to Ilex who advised the company on its clinical trials. "Our progress in this disease has been incremental over the past five to 10 years."

Sallan said if approved, the drug could be used to weaken a patient's leukemia to the point where a bone marrow transplant might be successful.

Ilex licensed Clolar from Bioenvision Inc., a New York biopharmaceutical company. Genzyme said it expects the acquisition of Ilex to close this month.

Earlier in its review of Clolar, the FDA awarded the treatment orphan-drug status. That confers expedited review and extended patent-protection benefits to treatments for diseases with small patient populations for which there are no existing therapies. Genzyme has built much of its business on developing orphan drugs, largely in rare genetic conditions.

"This is a Genzyme-style oncology treatment," said Mark Enyedy, senior vice president and general manager of Genzyme's oncology business. "These patients have few or no options when they get to this stage of the disease. This drug provides a demonstrated clinical benefit."

The split ruling by the advisory panel seemed to disappoint investors. On a day when markets soared and biotech indexes posted sizable gains, Genzyme shares declined about 1 percent. Ilex shares gained 10 cents, or less than half of 1 percent, to $24.96. Shares of Bioenvision fell $1.92, or 18.6 percent, to $8.38.

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GENZ, ILXO,

Source: The Boston Globe

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