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RHONE-POULENC RORER LICENSES NOVEN PROGESTIN PATCHES

Executive Summary

RHONE-POULENC RORER LICENSES NOVEN PROGESTIN PATCHES under an agreement announced June 29. RPR will receive worldwide marketing rights to Noven's progestin transdermal patch and its combination estrogen/progestin patch. Both products are "intended for use in postmenopausal related disorders including the relief of menopausal symptoms, the prevention of bone loss and osteoporosis," the two companies said. Miami-based Noven expects to file INDs for both products during 1992. RPR will also receive Japanese marketing rights to Noven's Phase III estrogen replacement transdermal patch, Menorest. RPR previously had rights worldwide except North America and Japan; Ciba-Geigy has North American rights from Noven. The company forecast a 1992 NDA filing for Menorest at a February securities analysts meeting ("The Pink Sheet" Feb. 24, p. 12). While Noven is currently pursuing an NDA for the estrogen patch, an ANDA (citing Ciba-Geigy's Estraderm as the innovator) has been pending at FDA since 1989. As part of the deal, RPR paid $5 mil. for warrants to purchase 1 mil. Noven shares (about 6.5% of the company) exercisable for an additional $8 mil. The companies did not estimate the total value of the agreement. RPR will also fund construction of a manufacturing facility for transdermals, to be leased by Noven, and pay all development costs for the three products. The new manufacturing facility will supplement Noven's own plant, which the firm estimated in February would be capable of producing 25 mil. units per year. Rhone-Poulenc Rorer said that the deal would help it "to build on our global bone metabolism franchise with innovative, life- enhancing hormone replacement therapy products." RPR currently markets the bone metabolism product Calcimar (calcitonin). Noven completed a secondary public offering in April, raising $17.7 mil. The company sought public equity after a proposed merger with Ivax fell through in October ("The Pink Sheet" Oct. 28, 1991, In Brief). Noven ended 1991 with $2.4 mil. in cash on hand. In addition to the hormone replacement products, Noven has an ANDA pending for a transdermal nitroglycerin patch.

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