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Executive Summary

CYGNUS CONTRACEPTIVE PATCH CLINICALS EXPECTED TO BEGIN during the last quarter of this year, the company said. The contraceptive patch is a co-development project between Cygnus and Family Health International (FHI). Cygnus is currently developing formulations for the patch containing ethinyl estradiol and progestin. "The patch would last seven days and would be replaced once a week for three weeks [and] a drug-free patch would be worn for the fourth week," Cygnus stated in a Jan. 22 press release. Cygnus said it expects the effectiveness of the transdermal patch to "match" that of birth control pills. In addition to a potential convenience advantage over oral contraceptives, Cygnus suggested, the patch may also offer a better side effect profile. Steroids delivered by the transdermal patch will bypass the liver and result in "a reduction in unwanted metabolic compounds . . . [and] it may also achieve a reduction in the risk of high blood pressure, blood clots and stroke," Cygnus said. Family Health International, a research organization that runs a contraceptive development and evaluation program, will develop the protocols and conduct the clinicals. Based in Research Triangle, N.C., FHI is funded by the Agency for International Development, which, FHI said, may decide to purchase some of the patches. The agency would then distribute the patches to overseas missions or organizations sponsoring family planning programs in underdeveloped countries. Cygnus said it will probably look for a marketing partner for U.S. sales of the contraceptive patch. Last January, the company announced an agreement with the French pharmaceutical firm Sanofi for two transdermal products, including an estradiol patch in Phase III clinicals. Cygnus has also finalized contracts with two other companies, Pharmacia and Farmos, a Finnish pharmaceutical firm, for undisclosed transdermal delivery products. Redwood City, California-based Cygnus expects the patch to be on the market in the next three to five years. Wyeth has a low dose levonorgestrel and ethinyl estradiol contraceptive patch in clinicals. Cygnus is also working on a fentanyl patch that it plans to license by the end of February.

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