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Executive Summary

ROCHE WILL COMARKET GLAXO's ORAL CEFUROXIME IN THE U.S., as a follow-up to the collaboration on Zantac (ranitidine). An NDA for the second generation oral cephalosporin is currently pending at FDA. Approval in the U.S. is expected in 1987, according to Glaxo's press release announcing the deal. Cefuoxime will be Glaxo's first oral cephalosporin in the U.S. The drug is marketed in I.V. form under the tradename Zinacef. Glaxo was studying the oral form under the trademark, Axoril. "The combined sales forces of Glaxo and Roche will help provide a high level and quality of professional support, essential for this antibiotic product, and will help establish it quickly as an important new therapeutic entity," Glaxo Senior VP-Marketing and Sales Alan Steigrod declared. The drug will be marketed by both companies under a Glaxo brand name, the company said. Cefuroxime will compete with Lilly's Ceclor as an oral cephalosporin. Under a nonexclusive licensing agreement with Glaxo dating from 1969, Lilly also holds approved ANDAs for I.V. cefuroxime under the name Kefurox. "We have an excellent relationship with Glaxo," Roche VP Patrick Zenner commented. "From the combined efforts of the Roche and Glaxo detail forces, our agreement for Zantac has been successful over the past three years, and we feel that this opportunity will be equally positive for both companies." Roche's first cephalosporin product, the injectable Rocephin (ceftriaxone sodium), is reportedly approaching the $80 mil. annual sales level in the U.S. Anti-infectives are an increasingly important therapeutic area for Glaxo. In its most recent annual report for fiscal 1986 (year ended June 30), the company said that worldwide sales of systemic antibiotics increased 61% over fiscal 1985 levels to approximately $280 mil. The firm's chief product is the third generation injectable cephalosporin ceftazidime, which was launched in the U.S. as Fortaz. Anti-infective R&D is the largest segment of Glaxo's research budget, accounting for 22%, or $38 mil. of the company's total $174 mil. R&D expenditure in fiscal 1986.

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