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Executive Summary

Fisons' representatives met with FDA on March 23 to discuss their NDA submission for Pneumopent (aerosolized pentamidine). The meeting with FDA is indicative of how close the British firm is to completing its NDA for the Pneumocystis carinii pneumonia treatment. Although trailing LyphoMed by just weeks in the race to submit an NDA with the ultimate aim of first approval and seven years of Orphan Drug exlusivity, Fisons is making an effort to avoid being locked out of the first advisory committee meeting scheduled to review aerosolized pentamidine. FDA's Anti-infective Drug Products Advisory Committee will review aerosolized pentamidine at its May 1-2 meeting ("The Pink Sheet" March 20, T&G-1). At present, only LyphoMed's aerosolized pentamidine is scheduled for review by the committee, according to FDA. However, even if the agenda for the meeting is not changed at this late date to include Fisons, FDA indicated that the British company can still ask for the opportunity to make a presentation during the public hearing portion of the meeting. LyphoMed began submission of its NDA in November 1988 and, based on earlier company projections, has apparently completed its filing. Fisons, which reportedly has begun to file its NDA, is not expected to complete its submission until early April. LyphoMed's slight edge in submitting its data to FDA has given the company a big advantage in negotiating the FDA approval process. Before the company completed its clinical data submission, FDA contacted the firm to request a Treatment IND application. LyphoMed received Treatment IND approval on Feb. 6 ("The Pink Sheet" Feb. 13, p. 10). An advisory committee approval recommendation, compounded by widespread availability of the drug under a Treatment IND, would make it very difficult for FDA to deny first approval to LyphoMed. Fisons has several bargaining chips available to persuade FDA to consider at least a simultaneous approval with LyphoMed. Fisons is expected to apply for a Treatment IND in the very near future, if it hasn't already. If approved, FDA would have to ask Fisons to withdraw its product from the market if the agency were to give a first, solo approval to LyphoMed. However, FDA's interest in avoiding additional physician and patient confusion with the Treatment IND process might preclude the agency from granting two Treatment INDs for the same drug. The Treatment IND situation is further clouded by the different kinds of clinical studies conducted by LyphoMed and Fisons. Whereas LyphoMed's Treatment IND protocol, which includes once-a-month treatment with 300 mg pentamidine, is based on a single unblinded study comparing different dosage regimens of the drug, Fisons conducted two different double-blind, controlled studies, including one placebo trial, with twice-a-month drug regimens. However, because of FDA's well known preference, where possible, for double-blind, placebo comparison studies, the agency may have a difficult time refuting Fisons' claim that its efficacy data is superior to LyphoMed's. Fisons will also likely argue that its nebulizer, FISONeb, is more convenient than the Respirgard nebulizer used in the LyphoMed trials and approved under the Treatment IND. Fisons' nebulizer is portable. Finally, Fisons may offer to cut its price for pentamidine well below the $ 100 per use charge for LyphoMed's Pentam. LyphoMed's aerosolized product, although used differently, is the same as Pentam I.V. and carries the same $ 100 a vial price under the Treatment IND. Because of the interchangeability of the two products, the effective product exclusivity under the orphan designation boils down to two years; LyphoMed's exclusivity for Pentam I.V. runs out in 1991.

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