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Executive Summary

Noven Pharmaceuticals expects to file an NDA for its transdermal estrogen patch during 1992, Exec VP-Marketing and Sales Billy Beal said at a Mabon Securities conference on drug delivery Feb. 19 in New York City. Noven's 84-hour (three-and-a- half-day) estradiol patch is in Phase III clinical trials, Beal said, adding that "we expect to file [an NDA] very shortly." Noven has had an ANDA pending for the product since September 1989. "Because there was some controversy and some slowdown in terms of approving ANDAs at FDA," the company decided to pursue an NDA as well in order "to cover all the bases," Beal said. Estrogen replacement therapy is indicated for treatment of symptoms associated with menopause and for prevention of post-menopausal osteoporosis. Under a November 1991 agreement, Ciba-Geigy has marketing rights to the patch in the U.S. and Canada. Ciba-Geigy already markets Estraderm, the only approved estradiol patch. Rhone- Poulenc Rorer has marketing rights to Noven's patch in all other countries except Japan. RPR is expected to file for approval overseas in 1992 as well, Beal said. In a Feb. 18 prospectus for a public stock offering, Noven maintains that its product offers "improved adhesion, less skin irritation and more predictable blood levels" compared to Estraderm, and is also cosmetically superior. "Ciba-Geigy will market [the Noven] system along with its current transdermal estrogen product," the prospectus says. Ciba-Geigy paid a licensing fee for Noven's product and will make payments upon submission and approval of the NDA, according to the prospectus. In addition to marketing rights, the Swiss company received five- year warrants to purchase 966,184 Noven shares for $2.5 mil. In other product areas, clinical trials of Noven's transdermal nitroglycerin patch for angina treatment have been completed, Beal said. The company plans to file an ANDA in the first half of 1992. The regulatory status of transdermal nitroglycerin is unusual since the innovator products are DESI drugs and considered "conditionally" approved. All three sponsors of the original transdermals -- Ciba-Geigy, Searle, and Schering-Plough/Key -- collaborated to provide the clinical data needed to upgrade their status. While FDA has approved several products as ANDAs, it is unclear what the agency will require of ANDAs once the innovators' status is upgraded. Noven Chairman Steven Slabotsky acknowledged that "it is up in the air, it is uncertain," but maintained that "the window of opportunity is absolutely still there for an ANDA for nitroglycerin depending on what product you use as the innovator." However, Slabotsky declined to elaborate on his company's strategy as far as regulatory requirements are concerned. Slabotsky and Beal both worked at Key Pharmaceuticals when it launched its Nitro-Dur nitroglycerin patch. Noven is also developing a transoral mucosal anesthetic, currently in Phase I/II trials for pre-injection numbing and for replacement of intraoral anesthetic injections before periodontal curettage, scaling, or cleaning, Beal said. The company also has transdermal progestogen, estrogen/progestogen, albuterol, alprazolam, and miconazole in the "development phase." Noven said in June 1990 that it was "close" to filing an IND for transdermal progestogen ("The Pink Sheet" June 4, 1990, In Brief). Noven is also developing a patented iontophoretic transdermal drug delivery system. Miami-based Noven's 2.5 mil. share secondary offering is being managed by Mabon. At current share prices, the company would net about $20 mil. Proceeds will go for improved manufacturing facilities and research and development, the prospectus says. Noven had about $2 mil. in working capital at the end of 1991. Noven recently struck a deal to merge with Ivax ("The Pink Sheet" Sept. 23, 1991, p. 18). That deal was abandoned because it did not meet "pooling of interests" accounting requirements ("The Pink Sheet" Oct. 28, 1991, In Brief).

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