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Executive Summary

LEDERLE DISCONTINUING VIPROSTOL BALDNESS STUDIES, WILL GO COSMETIC route to a product for hair thinning, American Cyanamid noted in an April 19 press release reporting the firm's first quarter financial results. Through its Shulton Group, the company plans to introduce at the beginning of 1989 a new line of cosmetic products for men with thinning hair beginning in 1989. "The [new Shulton] line is based on experience gained from products included in a three-prong study on the treatment of male pattern baldness, and from research of consumer needs and desires and Shulton's assessment of the market potential," Cyanamid Chairman George Sella remarked. "The study included the vasodilator viprostol, a carrier lotion and a placebo, [and] the individual differences in the results were not sufficiently significant to warrant further effort on viprostol." In late 1986, Lederle enrolled over 1,000 male patients at 28 centers for the Phase III study of viprostol as a topical, prescription treatment for pattern baldness ("The Pink Sheet" Oct. 6, 1986, T&G-2). An earlier trial had tested the vasodilator in 150 patients at eight centers. At the time that Lederle expanded the clinical program, the company acknowledged the difficulty that lay ahead, noting that is was "too early" to determine whether the program would lead to "an efficacious product." After a review of the six-month data, which occurred in the first quarter of 1988, the company decided to discontinue viprostol studies "in view of the modest response rate in a limited market . . . and the cost of further studies."

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