SYNTEX/P&G OTC NAPROXEN CLINICAL STUDIES IN PROGRESS

Executive Summary

SYNTEX/P&G OTC NAPROXEN CLINICAL STUDIES IN PROGRESS, the two firms noted in a release announcing the Sept. 19 signing of a definitive joint venture agreement. "Additional studies required to gain marketing approval [for OTC naproxen] are under way," the companies said. The agreement establishes a 50-50 joint venture company to market an OTC formulation of naproxen and other OTC drugs for pain and inflammation. The joint venture agreement also includes P&G's OTC acetaminophen/phenyltoloxamine product, Percogesic, which is marketed by the firm's Rich-Vicks subsidiary. Called Procter-Syntex Health Products Company, the joint venture will operate out of Rich-Vicks' facilities in Wilton, Connecticut. The company will be managed by a committee consisting of an equal number of representatives from Syntex and Procter & Gamble. In March, when the agreement-in-principle was first announced, the firms noted that Syntex had been meeting with FDA to discuss the type of studies necessary for an OTC formulation of the nonsteroidal anti-inflammatory agent naproxen. Syntex indicated that one aim of the clinical program would be to identify the appropriate strength for an OTC product. Upjohn and Boots, in seeking approval for an OTC strength of ibuprofen, conducted studies with a strength that was half the lowest approved dosage. Syntex' prescription brand of naproxen, Naprosyn, is marketed in 250, 375 and 500 mg. tablets. In addition, P&G and Syntex noted that "separate agreements have also been signed which may lead to further collaboration on prescription drug products and/or additional OTC products," most likely in the pain and inflammation areas. Syntex indicated that the agreements provided for potential future collaboration on agents currently in the early research stages.