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Executive Summary

ORGANON WILL MARKET FIRST DESOGESTREL-CONTAINING ORAL CONTRACEPTIVE IN U.S. following the Dec. 10 approval of its Desogen (.15 mg desogestrel/.03 mg ethinyl estradiol) birth control pill in both 21- and 28-day regimens. Organon, a subsidiary of Dutch chemical maker Akzo, said it will launch the contraceptive "almost immediately." Organon filed the Desogen NDA (20-071) in December 1990. In post-approval press materials, Organon is emphasizing that Desogen is "the most prescribed oral contraceptive in the world." This will also be the most prominent theme in the firm's planned advertising and promotion campaign for the product, Organon said. The company has engaged the New York ad firm Levy Wolfe Swift to develop journal ads aimed at physicians and pharmacists. No direct-to-consumer ads are planned. Akzo has marketed desogestrel- containing OCs overseas under the Marvelon brand since 1981. The "precautions" section of patient labeling for the product states that "high density lipoprotein cholesterol and triglycerides may be increased, while low-density lipoprotein cholesterol and total cholesterol may be decreased or unchanged." The company said this phrase was "unique" to Desogen labeling but that Organon will not make cholesterol lowering claims in its promotional materials. Organon's 480-rep sales force will detail Desogen to medical professionals. The sales force has been expanded from 150 reps two years ago in anticipation of the Desogen launch, Organon said. The firm currently markets Jenest 28 (norethindrone/ethinyl estradiol) OCs in the U.S., as well as a product line including the anesthetic Norcuron (vecuronium) and the fertility drug Pregnyl (chorionic gonadotropin). Ortho will comarket the product in the U.S. and Canada as Ortho-Cept. The J&J subsidiary's version of the drug had not yet been cleared by FDA as of Dec. 11. Ortho expects its desogestrel OC to help bolster its contraceptive sales in the U.S. as one of two new brands it will be promoting. In late September, Ortho began marketing the Ortho- Cyclen (ethinyl estradiol/norgestimate) OC, which it called "the first new oral contraceptive in 20 years" in the U.S. ("The Pink Sheet" Oct. 26, p. 14). Ortho also has recently begun a consumer ad campaign for its older Ortho-Novum 7/7/7 ("The Pink Sheet" Sept. 14, T&G-3).

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