12:00 AM
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Aug 20, 2007
 |  BioCentury  |  Strategy

Making economic Genasense

Genta Inc. began selling Genasense on a named-patient basis last week to any cancer patient outside the U.S. who wants it, even though the compound has been turned down for regulatory approval twice in the U.S. and once in Europe in the last three years. The company said named-patient sales would offset some of the costs of an ongoing Phase III trial that GNTA hopes will be sufficient for approval in Europe.

The named-patient program will allow GNTA to provide Genasense at a price roughly equivalent to market value, according to Chairman and CEO Raymond Warrell. He told BioCentury it's the only way the company can afford to continue pursuing full regulatory approval of the product, which consists of antisense agents targeting Bcl-2 mRNA.

"We can't afford to give the drug away ex-U.S., and this will allow us to cover some of the development costs," he said.

GNTA (Berkeley Heights, N.J.) is hoping data from the Phase III AGENDA trial in 300 patients with advanced melanoma will be sufficient to obtain marketing approval in Europe. It would be a long time coming. According to Warrell, Genasense has consumed more than $750 million in development costs over the past two decades.

Initially partnered with Aventis S.A., Genasense oblimersen suffered its first major regulatory mishap in 2004. FDA's Oncologic...

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