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UPJOHN PLANS ANSAID LAUNCH FOR EARLY 1989 FOLLOWING APPROVAL ON NOV. 1; ANSAID IS THIRD NSAID APPROVED IN ELEVEN MONTHS AFTER VOLTAREN, RIMADYL

Executive Summary

Upjohn is delaying launch of its new nonsteroidal anti-inflammatory agent Ansaid (flurbiprofen) until "the first part of 1989." The drug was approved by FDA on Oct. 31. According to the approved labeling, Ansaid is indicated for "the acute or long-term treatment of signs and symptoms of rheumatoid arthritis and osteoarthritis." The warnings and precautions sections in the Ansaid labeling are relatively clean. Ansaid's warnings section includes the recently adopted gastrointestinal ulcer "class" label statement. Like other NSAIDs, Ansaid's label includes a statement on impaired renal or hepatic function among general precautions. However, unlike the recently approved Voltaren, Ansaid labeling does not recommend periodic liver function tests. The Ansaid approval represents a tricky marketing situation for Upjohn. Currently, the company is concentrating its marketing and promotional efforts on the launch of the antibaldness drug Rogaine. Upjohn will be trying to position Ansaid in the wake of Ciba-Geigy's introduction of its NSAID Voltaren, approved in July. Launched in September, Voltaren has been made the top priority of of the 900-person combined sales force of Ciba and Geigy. In less than two months, Voltaren is understood to have made a major dent in the U.S. NSAID market. Like Voltaren, Ansaid also should benefit from significant experience with the drug outside of the U.S. Ansaid has been marketed overseas since 1977, including ten years of marketing in the U.K. The drug is currently available in 70 countries outside the U.S. and has been involved in "more than 1 bil. patient days of therapy," Upjohn said. Boots, which also was the source for Upjohn's first NSAID Motrin, developed Ansaid and licensed the North American rights to Upjohn. In 1986, Upjohn received exclusive rights to the oral version of flurbiprofen in return for giving up rights to E-Mycin to Boots. After a six-and-one-half year review at FDA, the approval of Ansaid came soon after the drug reached the approval stage on Oct. 18 ("The Pink Sheet" Oct. 31, T&G-1). Ansaid does not qualify as a new chemical entity approval, however. A topical formulation of flurbiprofen, licensed to Allergan and marketed under the Ocufen brand, was approved in December 1986. Ansaid's long review at FDA was due, in part, to the agency's request that safety data from a Boots submission be consolidated into the Upjohn NDA. Initially, data supporting Ansaid's approval was submitted by both Boots and Upjohn, which, prior to 1986, held a nonexclusive license to market the drug in the U.S. Ansaid will be available in 50 and 100 mg tablets. According to the drug's labeling, the recommended starting dose for both osteoarthritis patients and rheumatoid arthritis patients is 200-300 mg per day given in two, three or four equal doses. The label notes that "most experience in rheumatoid arthritis has been with t.i.d. ]three times daily[ or q.i.d. ]four times daily[ dosage."
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