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Executive Summary

MARTEC LICENSES SEROTONIN RE-UPTAKE INHIBITOR FEMOXETINE from the Danish company Ferrosan. "Femoxetine represents the first of many new compounds Martec is actively negotiating to develop for marketing approval in the U.S. and other countries," Martec said in a Sept. 15 release announcing the agreement. Signed on Sept. 15, the agreement, "licenses Martec to develop and market femoxetine -- a new and novel antidepressant drug -- for the North American continent." To date, Martec has focused on generic drug distribution. The company currently markets 31 generic drug products, most of which were obtained through licensing agreements. Since its inception in 1984, Martec has received two ANDA approvals, metoclopramide and propranolol. U.S. clinicals with femoxetine will begin "as soon as possible so that we may gain marketing approval in the shortest time span," Martec said. Martec hopes to rely on preclinical safety data generated by Ferrosan in Europe for its IND submission. For the NDA, the company said it plans to do two clinical trials in the U.S. as well as use human study data produced by Ferrosan. Femoxetine is currently in clinicals in Europe. "Given the favorable preliminary results in over 800 patients who received femoxetine in clinical trials in Europe, one can expect a solid market for this drug [as an antidepressant] in the North American continent," Martec said. The company noted that it may also pursue indications for treatment of obesity and alcoholism. In a Ferrosan study on 73 patients published in the British journal, International Journal of Obesity, 600 mg of the drug "tended towards causing a larger weight loss" than placebo in a subgroup of patients with obesity problems for more than 20 years. Overall, however, the "results showed that there was no statistically significant greater weight loss in patients treated with femoxetine (median = 8.3 kg) than with placebo (median = 6.2 kg) after 16 weeks." The same study notes that in depression, femoxetine "has been shown to have an antidepressant efficacy which is comparable with the efficacy of amitriptyline and imipramine." Lilly received an approvable letter for its serotonin uptake inhibitor Prozac (fluoxetine) earlier this month ("The Pink Sheet" Sept. 14, "In Brief"). Other firms developing serotonin inhibitors for depression include: Pfizer, in Phase III clinicals with sertraline; and Janssen, in Phase I studies with rianserin. Martec is a subsidiary of Kansas City Southern Industries, a diversified company with 1986 revenues of over $500 mil. The parent company will be funding the femoxetine development program. In preparation for femoxetine marketing, Martec has planned to increase its current sales force of nine reps to 50 before the end of 1988 and to 125 before the end of 1989. Martec noted that it is also working on another, as yet undisclosed, innovative new drug product via a licensing agreement that it believes could be on the market by 1989.

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