Biotech Values

[DewDiligence]

More on GNTA from FT:

[Note the pointed quotation by pharma guru Viren Mehta.]

http://tinyurl.com/3edg7

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FDA rejects cancer drug in blow to Aventis

By Victoria Griffith in Boston
May 4 2004

A US Food and Drug Administration advisory panel on Monday rejected an application from Genta and Aventis for the experimental cancer drug Genasense, demonstrating that the agency has not loosened its requirements to the extent some had hoped.

A request for approval for the treatment, designed to treat a deadly type of skin cancer, was controversial. “I think it would have been strange for the FDA to clear the drug, based on the quality of the information Genta submitted,” said Viren Mehta of Mehta Partners, the pharmaceutical analysis firm. “They chose not to disclose data from two other trials of the drug, even though the studies were complete. That's very unusual.”

Genta argued that the condition of patients taking Genasense appeared to deteriorate more slowly. The FDA, however, said the data were unclear, and that much of the improvement noted may have been due to chance.

An easing of requirements by the agency during the past two years had raised hopes that Genasense might be cleared. The FDA had become particularly amenable to new products for diseases with few treatment options, including many types of cancer.

Two years ago, obtaining the go-ahead from the FDA meant showing improved survival rates for cancer patients. The approval of AstraZeneca's Iressa in late 2002, however, signaled a shift in the approval process. Instead of extended survival, the FDA argued it could clear cancer drugs based on other factors, such as tumour shrinkage. The looser approach later led the agency to give the green light to the controversial colon cancer drug Erbitux, made by ImClone. Genasense was key for Genta, but also important for Aventis, which had cut a $480m dollar deal for rights to the compound.
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