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LEDERLE TO MARKET DEXFENFLURAMINE ANTI-OBESITY COMPOUND FROM INTERNEURON

Executive Summary

LEDERLE TO MARKET DEXFENFLURAMINE ANTI-OBESITY COMPOUND FROM INTERNEURON under an agreement announced Nov. 19. Lederle Labs parent American Cyanamid paid $2 mil. in cash for a license to the serotoninergic agent and purchased approximately 240,000 shares of Interneuron convertible preferred stock for $3 mil. Interneuron will also receive milestone payments and royalties on any product sales. The Lexington, Mass. R&D firm will retain manufacturing and certain copromotion rights. Dexfenfluramine is in Phase III trials at 18 sites in the U.S. Interneuron said it plans to file an NDA "in early 1993." The compound is already marketed in 40 countries outside the U.S. Interneuron licensed dexfemfluramine from the French firm Les Laboratoires Servier in 1990. The drug acts by both stimulating the release of serotonin and by blocking its reuptake in the brain, Interneuron said. "By increasing the levels of serotonin in the brain, it is believed that dexfenfluramine 'fools' the brain into thinking that the body has ingested more carbohydrates and fats than it actually has," the company said. More than 4,000 patients have been treated in worldwide trials of dexfrenfluramine, Interneuron said, including 600 in the U.S. Clinical trials show that treated individuals "lose weight at a rate up to double the weight loss experienced by patients taking a placebo, and they maintain their weight loss while taking dexfenfluramine." Some patients "may need repeated courses of dexfenfluramine treatment, while other may need only one." Dexfenfluramine "appears to have a mild side-effect profile," Interneuron said. Interneuron claimed that dexfenfluramine's dual mechanism of action differentiates the product from other serotonin reuptake inhibitors like Lilly's Prozac (fluoxetine). Specifically, Interneuron maintained that dexfenfluramine may have a different side-effect profile than Prozac. Lilly has an NDA pending for fluoxetine for treatment of obesity, which the company intends to market under the name Lovan. According to Interneuron, between 25% and 30% of the U.S. population is obese (more than 20% heavier than ideal weight). The firm estimates that "at least two thirds of obese people can be considered carbohydrate cravers" who could be helped by dexfenfluramine. The drug was highlighted during an April National Institutes of Health conference on weight loss ("The Pink Sheet" April 6, p. 11). Lederle described the market for the product as analogous to that for its ProStep and the other nicotine smoking cessation patches. Lederle indicated that a consumer education program similar to that used for the heavily advertised patches would be necessary for prescription obesity products as well. Lederle has a sales force numbering 1,000. The firm's currently marketed CNS drugs include the antidepressant Asendin (amoxapine) and the antipsychotic Loxitane (loxapine). Interneuron has raised at least $26 mil. so far in 1992. In addition to the $5 mil. from American Cyanamid, the firm grossed $21 mil. from two warrant redemptions earlier this year. In addition, Interneuron received an undisclosed payment early in November from Veryfine Products, Inc., in exchange for a license to Interneuron's choline sports drink.(
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