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SEARLE's FIRST NSAID WILL BE OXAPROZIN, LICENSED FROM WYETH-AYERST

Executive Summary

SEARLE's FIRST NSAID WILL BE OXAPROZIN, LICENSED FROM WYETH-AYERST for marketing in the U.S., Puerto Rico, Canada and the Caribbean. In a Dec. 12 release announcing the agreement, Searle noted that "oxaprozin is expected to be administered once daily for the treatment of both osteoarthritis and rheumatoid arthritis, based on results of clinical studies in more than 3,000 patients." An NDA for the NSAID has been pending at FDA since 1982. The product could be the second NSAID approved for once-a-day dosing. Currently, only Pfizer's Feldene (piroxicam) is labeled for once-daily administration. Wyeth-Ayerst's decision to license oxaprozin (Durapro) may reflect the firm's high expectations for another pending NSAID, Ultradol (etodolac). In annual reports, the firm has touted the NSAID as "ten times more potent than aspirin" with "gastrointestinal and pharmacologic advantages." An NDA for Ultradol was submitted in late 1982, months after the oxaprozin submission. The American Home Products subsidiary also has an application pending for a once-daily version of ketoprofen (Orudis), which was approved in early 1986 for t.i.d. or q.i.d. dosing. The once-daily product will be marketed under the tradename Oruvail. The firm submitted a marketing application for the sustained release NSAID this year. Both oxaprozin and Ultradol could be candidates for approval in the near future. The agency has recently begun to move on the backlog of pending NSAID NDAs, with the approvals of Upjohn's Ansaid, cleared on Oct. 31, Ciba-Geigy's Voltaren, cleared on July 28, and Roche's Rimadyl, approved in late 1987. The oxaprozin deal is Searle's second publicly announced licensing agreement. Last year, the firm licensed the quinolone antibiotic lomefloxacin from Hokuriku Seiyaku of Japan. Since Monsanto's acquisition of Searle in 1985, the company has publicly stated its intent to increase products in the pipeline through licensing agreements and heavy cash support of R&D. Although oxaprozin will be Searle's first entry into the NSAID market, the company is also hoping to receive approval soon for Cytotec as a preventative for NSAID-induced gastric ulcers (see story, p. 5). FDA's Gastrointestinal Drugs Advisory Committee recommended approval of the drug for patients at "high risk" of NSAID-induced ulcers at its Sept. 15 meeting. Commenting on the product fit, Searle said that the two drugs "demonstrate Searle's strategy of providing safe and effective therapies to arthritics, who comprise an estimated 10% of the U.S. population and 40% of persons aged 65 and older." Therefore, Searle continued, the company "expects shortly to have two drugs, both of which may be suitable for use in some 25 mil. patients in the country."
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