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Executive Summary

WARNER-LAMBERT's NICOTROL PATCH LAUNCH SLATED FOR AUGUST, the company said following manufacturer Cygnus Therapeutic Systems' July 6 announcement that it had begun shipping the transdermal nicotine patch to Warner-Lambert in preparation for launch. Nicotrol was approved on April 22 ("The Pink Sheet" May 4, T&G-4), and Cygnus' manufacturing process completed validation inspections in mid-June. Warner-Lambert said it expects to begin shipping Nicotrol to the trade in mid-July with retail availability at the start of August. The Nicotrol launch will be supported by direct-to-consumer print ads, Warner-Lambert said. TV ads are a possibility later on, the company added, although they are not planned to support the initial launch. Warner-Lambert has hired the advertising firm of Sudler & Hennessy (New York City) for the Nicotrol account. Warner-Lambert has an exclusive agreement with Smoke Stoppers to link Nicotrol to a smoking cessation program. Cygnus' first quarter report to shareholders states that Smoke Stoppers "is used by over 350 medical centers, corporations and labor organizations, including Yale New Haven Medical Center, American Airlines and the UAW-GM." Part of the marketing strategy for Nicotrol, Cygnus said, will be "to join forces with organizations, such as HMOs, corporations and labor unions, where smoking cessation programs are already well-developed." In addition, all patients prescribed Nicotrol will receive a free Smoke Stoppers kit. All three current marketers of nicotine patches -- Marion Merrell Dow (Alza's Nicoderm), Ciba-Geigy (Habitrol) and Lederle (Elan's ProStep) -- advertised the products directly to consumers at the start of the year. Advertising is currently in hiatus, however, as demand has outstripped supply for the products. At least one of the companies, Marion Merrell Dow, is planning a renewed campaign for mid- to late-summer. A second wave of nicotine patch promotion could be complicated by a July 14 meeting of FDA's Drug Abuse Advisory Committee. The committee will discuss recent reports of heart attacks associated with people smoking while wearing the patches and a petition for a boxed warning emphasizing that the patches are meant to be used as part of a comprehensive smoking cessation program ("The Pink Sheet" July 6, T&G-1). While negative publicity about an association between patch use and heart attacks could dampen the enthusiasm for the patches just as the new ad campaigns are breaking, the citizen's petition, filed in April by Public Citizen's Health Research Group, could prevent direct-to-consumer TV ads altogether. According to FDA regulations, prescription drugs carrying a boxed warning about health risks may not be advertised on television; an acknowledged goal of the petition is to prevent such ads. The Nicotrol patch also faces a patent challenge from Elan. On June 25, Elan announced that a California federal court judge had ruled that Cygnus did not infringe Elan's ProStep patent in developing Nicotrol due to "exemptions granted in respect to clinical studies reasonably required for approval." However, Elan said it is "confident" that Cygnus/Warner-Lambert's eventual marketing of Nicotrol will infringe because that action will not be protected by the exemptions. Patent suits also have been filed by Ciba-Geigy against Elan and Alza and by Elan against Ciba- Geigy. Alza and Elan recently settled their suits against each other.

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