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Executive Summary

GLAXO SALMETEROL TWICE-DAILY AEROSOL BRONCHODILATOR is being promoted by Glaxo as a new type of chronic treatment for asthma, in contrast to its albuterol products. The long-acting beta-2 agonist bronchodilator is seen by Glaxo as new use for bronchodilators, an addition to the chronic asthma therapies currently available: cromolyn sodium, steroids and theophyllines. Salmeterol is currently in Phase III trials in the U.S. A product registration was filed overseas in March for both dry powder and aerosol formulations. Salmeterol's merits as a Glaxo second generation asthma drug were presented to securities analysts May 31 at Glaxo Holdings' annual R&D update. Asked by an analyst if Glaxo is seeking a superior efficacy claim for salmeterol over Volmax/Ventolin, Director, Respiratory Clinical Research James Palmer said: "What you've got to understand here is that [salmeterol] is a completely different drug. It's not another ventolin," which he described as a "firefighting instrument." The NDA for salmeterol is planned for the second half of 1992, Glaxo said. Responding to a question as to why the NDA is expected to be filed "so much later" than applications in the rest of the world except for Japan, Palmer noted the more stringent study requirements mandated by FDA. He explained that FDA requires 12 hour lung function tests in all chronic dosing studies, which he described as a "much more labor intensive [procedure] than what we do in the rest of the world," which is to let patients record their own lung function twice a day. Salmeterol is one of two second generation asthma medications that Glaxo is developing. The other is fluticasone propionate, an anti-inflammatory steroid that is also planned as a treatment for allergic and seasonal rhinitis and as a topical for skin diseases. Glaxo's Palmer described fluticasone for asthma as a prophylactic inhaler formulation with superior efficacy and safety over the "gold standard" treatment for those patients with moderate to severe asthma. The drug is in Phase II in the U.S. Registrations are planned for the second half of this year in the U.K. and Europe. As an intranasal spray for perennial rhinitis, fluticasone is scheduled to be filed for approval "all over the world" in the second half of this year. Glaxo told the analysts. The drug was just recently approved in the U.K. for the rhinitis indication. The NDA for topical fluticasone in cream and ointment forms has been filed in the U.S.

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