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Executive Summary

GLAXO ADDING TO CEPHALOSPORIN LINE WITH MOCHIDA LICENSING AGREEMENT, which gives the U.K. firm exclusive rights to market the injectable antibiotic M-14659 outside of Japan. Under the agreement, announced Sept. 16, Glaxo will be responsible for development, manufacture, and marketing of the new antibiotic in all countries except Japan. Glaxo's Japanese subsidiary, Nippon Glaxo, will comarket the drug in Japan with Mochida, which will develop and manufacture the product in that country. Tokyo-based Mochida Pharmaceutical "will receive down payments and a running royalty as consideration for the license granted," Glaxo reported. Founded in 1945, Mochida has been synthesizing and investigating cephalosporin antibiotic derivatives since 1981. M-14659 is the first cephalosporin to be outlicensed by the Tokyo-based pharmaceutical company. M-14659 is still in the early stages of preclinical development. Glaxo indicated that the product would not be ready to enter human clinicals until 1988. However, Glaxo said that "early laboratory investigations on M-14659 have shown it to be a potent broad spectrum antibacterial agent active against both gram-negative and gram-positive organisms." Based on in Vitro studies, Glaxo said that the antibacterial's activity versus pseudomonas aeruginosa "appears to be stronger than any known antibiotic of its type." M-14659, Glaxo added, "is also effective against bacterial strains resistant to other cephalosporin antibiotics." Glaxo currently markets in the U.S. two third-generation injectable cephalosporins -- Fortaz (ceftazidime) and Zinacef (cefuroxime) -- and an injectable cephalothin under the Seffin brandname. In addition, Glaxo is expecting approval of its oral cefuroxime (Ceftin) in the near future. In an announcement of a comarketing agreement with Roche for the new oral cephalosporin, Glaxo predicted a 1987 approval. Glaxo is now running "available soon" ads in trade and professional journals.

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