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Executive Summary

FISONS PNEUMOPENT TREATMENT IND TARGETED FOR EARLY APRIL submission to FDA. A complete NDA filing for the aerosolized pentamidine product in the prophylaxis of Pneumocystis carinii pneumonia (PCP) will follow later in the month. Fisons hopes to have both applications reviewed in time for a scheduled May 1-2 meeting of FDA's Anti-infective Drug Products Advisory Committee. FDA is considering Fisons' request to present Pneumopent data at the May meeting. Currently, only Lyphomed's Pentam is scheduled for a formal presentation before the panel. Fisons met with FDA's Anti-Viral Division for a pre-NDA conference on March 23 ("The Pink Sheet" March 27, p. 6). In a March 9 letter to Anti-Viral Division Director Ellen Cooper, Fisons had informed the agency of its intentions to file for a Treatment IND and complete the NDA for Pneumopent in a dosing regimen of 60 mg every other week. At the March 23 meeting, Fisons presented data from its Canadian double-blind placebo-controlled study in which patients were given 60 mg every other week for four months. Data collected on 162 subjects shows that 5 of 84 patients treated with 60 mg Pneumopent every other week had a second histologically confirmed episode of PCP compared to 27 of 78 for placebo. Results of a second multicenter, double-blind, low-dose active control trial in the U.S. are still being analyzed. In that trial, patients received 60 mg or 120 mg doses once every two weeks with a 5 mg dose as the active control. Lyphomed's NDA for aerosolized Pentam is based on a single unblinded study comparing different dosing regimens. Fisons terminated both of its studies earlier than planned in response to the approval of Lyphomed's Treament IND. Fisons began analyzing data at the end of four months instead of the originally planned six months. The monthly dose of Pneumopent will be 120 mg versus the 300 mg dosage for Lyphomed's Pentam. Fisons said it will offer its product at a price of $ 50 per month compared to $ 100 for the Lyphomed product. Fisons is also likely to emphasize as an advantage Pneumopent's nebulizer, FISONeb. The device is portable, and only delivers drug when the patient is inspiring. The Lyphomed nebulizer, Respirgard II, requires compressed air from a stationary source and delivers a continuous spray of pentamidine. However, the price for FISONeb is considerably higher -- $ 250 versus about $ 20 for Respirgard II. Fisons is chasing Lyphomed in the race for approval and orphan exclusivity for the AIDS-related product. FDA granted a Treatment IND for Lyphomed's product on Feb. 6. However, since the aerosolized product is interchangeable with I.V. pentamidine, the effective exclusivity under the orphan designation will only amount to two years; Lyphomed's exclusivity for Pentam I.V. expires in 1991. In a separate action, Fisons received an approvable letter on March 27 for its second orphan product Gastrocrom (cromolyn sodium) for the treatment of systemic mastocytosis. The indication is relatively small; there are approximately 1,000 cases in the U.S. Fisons previously received orphan approval for Opticrom, a cromolyn sodium opthalmic solution used in the treatment of certain ocular disorders.

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