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ALLERGAN OFLOXACIN CLINICAL TRIALS WILL BEGIN IN EARLY 1987

Executive Summary

ALLERGAN OFLOXACIN CLINICAL TRIALS WILL BEGIN IN EARLY 1987 to evaluate the drug in the treatment of ophthalmic infections. The firm said Oct. 16 that it has obtained U.S. and Canadian rights to the quinolone antibiotic for ophthalmic indications from Daiichi Seiyaku of Japan. The license is being handled through Santen Pharmaceuticals, Allergan's joint venture partner in Japan. Allergan Chairman Richard Ulmer said in a press release that "we believe ofloxacin's broad spectrum of activity will provide excellent control of conjunctivitis and other external eye infections." Ofloxacin is not yet marketed in Japan but clinical trials testing the safety and efficacy of ofloxacin have recently been concluded. The Japanese equivalent of an NDA has been submitted for government approval. Ofloxacin has been evaluated against a wide range of infections outside of the ophthalmic area, including urinary tract and respiratory infections, and traumatic and postoperative wound infections. For example, one study was conducted in Germany, in 1986 on 879 patients with uncomplicated infections of the lower urinary tract. After three day treatments with ofloxacin were compared to three-to-seven-day treatments with other drugs including co-trimoxazole, nalidixic acid, and nitrofurantoin, ofloxacin was found to have the highest cure rate. Ulmer noted that the ofloxacin license is the first between Allergan and Daiichi. "We hope that this licensing agreement is the first step in a continuing relationship with Daiichi and expect that our experience in the ophthalmic market will produce the ideal complement to Daiichi's broader pharmaceutical interests," Ulmer said.

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