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Executive Summary

BOOTS ANTICIPATING MANOPLAX 1990 NDA FILING as a treatment for moderate to severe congestive heart failure. The company says the latest results are "encouraging" from its ongoing analysis of Phase III U.S. and U.K. studies of the drug. Data analyzed to date apparently suggest that Manoplax (flosequinan) is a more promising drug therapy than shown in preliminary results reported by U.K. parent Boots PLC on Sept. 22 ("The Pink Sheet" Oct. 2, T&G-8). The key Phase III U.S. trial comparing Manoplax to placebo was conducted at 20 centers involving 191 patients with moderate to severe congestive heart failure. The trial was directed by Milton Packer, MD, associate professor, Mount Sinai Medical Center Cardiology Division. The principal U.K. study looked at 140 patients and was similar in design. Preliminary results discussed by the company in September indicated an unexpectedly high placebo response. Boots explained at the time that "the variability in results is such that the improvement on flosequinan is not statistically significantly better than that on placebo." However, more complete data from both the U.S. and U.K. trials has since shown that the initial report was based on data that did not have normal distribution patterns, according to Boots. The variance has been "appropriately addressed" and the product has been shown to be superior to placebo, the firm said. Boots is in the advanced stages of analyzing U.S. and U.K. data for the U.S. at U.K. data for the oral nitroprusside arteriovenous vasodilator and an NDA filing in the first half of 1990 is in the realm of possibility, the company indicated. Boots is now "dotting the i's and crossing the t's" on the analysis and the results "look quite encouraging," the firm said. Boots is slated to discuss study results with investigators on Nov. 12. Worldwide registration of the drug could include results from up to six studies. The second key U.S. late phase study, similar to Packer's but larger, is scheduled to be completed in calendar year 1990. The study, comparing flosequinan to placebo and comparing two different dosage regimens, is being led by University of Michigan Director of Cardiology Bertram Pitt, MD. * Boots PLC's public disclosure of disappointing preliminary results in September was mandated by British stock exchange rules, which require a publicly-traded company to notify the stock exchange of any information that might cause the stock to move significantly. However, the firm noted at the time that the data were preliminary and analysis was ongoing.

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