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Executive Summary

Syntex and Procter & Gamble's joint venture to market OTC naproxen may be the first in a series of marketing and research agreements between the two companies, a joint March 8 press release declares. The two companies said that they are "also engaged in a series of other broad-ranging discussions regarding further collaboration." A Syntex spokesperson said the discussions cover "primarily marketing and research" agreements for other products. Syntex has met with FDA several times to determine what studies, beyond those done for the prescription product, may be required to market naproxen in an OTC form. P&G representatives have participated in some of the meetings, Syntex said. The company indicated that clinical studies of an OTC formulation have not yet begun. Syntex' prescription naproxen brand, Naprosyn, became the topselling nonsteroidal anti-inflammatory in the U.S. in 1986, suprassing Pfizer's Feldene. Combined sales of Naprosyn and Anaprox in fiscal 1987 topped $410 mil. in the U.S. and were $613 mil. worldwide. Base on six month sales of $336 mil., Naprosyn/Anaprox sales are headed for approximately $700 mil. worldwide during the current fiscal year, representing a near 15% increase over the past year. In addition to OTC naproxen, the joint venture will include "certain analgesic products and services provided by each company" under the agreement in principle. An OTC formulation of naproxen sodium (Anaprox) is included in the agreement as well as other analgesic products "sutiable for OTC marketing," Syntex said. The regulatory approach taken by Upjohn and Boots for OTC ibuprofen is a relevant model for the development of OTC naproxen. Upjohn and boots submitted NDAs for a lower dose ibuprofen product. The NDAs included new clinical studies. The Syntex development timetable for OTC naproxen appears to be similar to SmithKline's approach to OTC cimetidine. SmithKline recently announced a U.S. licensing agreement with Bristol-Myers for OTC cimetidine. Both Syntex and SmithKline appear to be timing the introduction of an OTC product a year or two before the patent expirations on the Rx products. That timetable allows establishment of the OTC brand, and extends a company's dominant position beyond the patent expiration. It also limits cannibalizing of the prescription product. Naproxen's patent runs out in December 1993 while SmithKline's Tagament patent expires in 1994. Approval of an NDA with new clinical studies evergreens exclusivity by earning a company three years of additional exclusivity for an OTC product. P&G's Rich-Vicks subsidiary is likely to assume marketing responsibility for the OTC naproxen product. Rich-Vicks currently markets Norwich Aspirin and Percogesic brands of OTC analgesics. Rich-Vicks' OTC analgesic product line makes P&G a good partner to market a new OTC ingredient. Rich-Vicks markets an aspirin brand and an acetaminophen brand, but does not have an ibuprofen brand that might be hurt by a naproxen Rx-to-OTC switch.

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