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Executive Summary

FISONS MEETS WITH FDA COMMISSIONER YOUNG TO DISCUSS PNEUMOPENT NDA and the future of the product in the wake of a Treatment IND approval for Lyphomed's aerosolized Pentam. Participants in the June 1 meeting included Young, FDA Drugs and Biologics Center Directors Carl Peck and Paul Parkman, and FDA Deputy Commissioner James Benson, as well as Fisons President Stephen Attwood, Memorial Sloan-Kettering Infectious Disease Service Chief Donald Armstrong, MD, and Covington and Burling attorney Peter Barton Hutt. Fisons presented data from its U.S. double-blind active control trials with its aerosolized pentamidine product Pneumopent to the FDA group in an attempt to demonstrate efficacy and possible advantages over Pentam. Fisons said that it has not yet filed the U.S. trial data, which will complete the NDA submission. Fisons has been trying to find an angle around the seven-year market exclusivity that Lyphomed likely will receive. The burden of proof will apparently be on Fisons to show that sufficient differences exist between Pneumopent and Pentam in order to consider them different drugs. The major difference between the two products is their nebulizer systems -- Pentam uses the Respirgard II with a compressor while Pneumopent uses the hand held atomizer FISONeb. Another potential selling point is that Fisons has proposed to market its product at 50% of the Lyphomed price , which is approximately $ 100 per 300 mg vial. There are indications that FDA is in a quandary about what to do with the Fisons product once it approves Pentam, possibly in the next couple of weeks. The agency is still considering Fisons' Treatment IND request and has asked the company to recheck some of the datapoints from its Canadian Pneumopent trials. The FDA request should take several weeks, Fisons said. Agency officials recently met with Congressional Health Subcommittee Chairman Henry Waxman's (D-Calif.) staff to discuss the orphan status of aerosolized pentamidine. Reportedly, Waxman staffers were interested in FDA estimates of the numbers of patients who would benefit from treatment with aerosolized pentamidine. FDAers attending the meeting included FDA Office of Drug Evaluation II Director James Bilstad, MD, Orphan Products Director Marlene Haffner, MD, General Counsel Thomas Scarlett, and Legislative Affairs staffer JoAnne Marrone.

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