Interneuron Pharmaceuticals Inc. announced Monday that ithas submitted a new drug application (NDA) to the FDA on itsanti-obesity drug dexflenfluramine.

In connection with this submission, the Lexington, Mass.,company (NASDAQ:IPIC) will receive $3 million, consisting of$2.5 million in cash and $500,000 through the purchase ofInterneuron convertible preferred stock as a milestonepayment from its sublicensee, American Cyanamid Co.(NYSE:ACY) of Wayne, N.J.

Dexfenfluramine, which is an organic small molecule compoundthat acts by stimulating the release of the neurotransmitterserotonin as well as inhibiting its re-uptake, was discovered byServier France. Richard Wurtman, director of the clinicalresearch center at the Massachusetts Institute of Technologyand a founder and director of Interneuron, and JudithWurtman did a number of studies with the French compoundon its ability to treat obesity and the abnormal craving ofcarbohydrates. (It's known that elevated levels of serotoninhelp an individual feel full, and that food rich in fats andcarbohydrates can help release serotonin.)

That work formed the basis of several patents, awarded toMIT, on the use of dexfenfluramine for treating abnormalcarbohydrate craving, explained Bill Boni, Interneuron'sdirector of corporate communications.

MIT then licensed those patents exclusively to Servier, whichproceeded to "do a lot of the work that enabled the product tobe commercialized in France," Boni said. Servier now marketsdexfenfluramine in more than 40 countries worldwide fortreating obesity.

"After Interneuron was founded, we were able to license backfrom Servier the exclusive U.S. rights to the drug for treatingobesity," Boni told BioWorld. In turn, Interneuron grantedexclusive U.S. marketing rights to Cyanamid's Lederle Labs inNovember 1992.

The NDA contains data from clinical trials on more than 4,000patients in the U.S. and Europe, explained Bobby Sandage,Interneuron's vice president of medical and scientific affairs. Ofthose, approximately 700 patients were involved in the U.S.trials, which Interneuron conducted. Eighteen of the trials weredouble-blinded and placebo-controlled, and both groups ofpatients in any one trial were on the same dietary regimen.The bottom line: Patients taking dexfenfluramine lost twice asmuch weight as those on the placebo, Boni said.

Interneuron in March netted $13.5 million in a follow-onoffering of 2.3 million shares of its common stock at $6.50 pershare, in part to complete the preparation of the NDA fordexfenfluramine. The company has about 30 million sharesoutstanding, fully diluted, and at the end of March had $22.3million cash on hand, Boni told BioWorld.

Interneuron's stock closed at $8.75 a share on Monday, up 25cents.

-- Jennifer Van Brunt Senior Editor

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