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Executive Summary

LYPHOMED's AEROSOLIZED PENTAMIDINE GIVE-AWAY PROGRAM for indigent patients is expected to begin "before the end of the year," the company said. The firm has begun contacting community-based health care providers and AIDS physician groups to determine their needs for Nebupent (aerosolized pentamidine), approved June 15 for prophylaxis of pneumocystis carinii pneumonia. After determining the amount of the drug needed, Lyphomed plans to establish criteria that indigent patients must meet in order to qualify for the program. The plan is aimed to "fill the insurance gap" for some, but not necessarily all, patients who can not receive reimbursement for the drug, according to the company. Lyphomed had previously announced its intent to provide an indigent patient give-away program when it received a Treatment IND for aerosolized pentamidine in February. At that time, the company estimated the total value for the indigent patient program, including the amount used in continuing clinical trials, to be $4-$5 mil. ("The Pink Sheet" Feb. 13, p. 10). However, the company has declined to put a current price tag on the cost of the program. A recent announcement by the New York-based People With Aids Health Group that it planned to sell imported pentamidine in the U.S. at a 60% discount may have prompted Lyphomed to step up efforts to establish its own program. The underground buyers' club announced Sept. 25 that it would buy the drug in England and resell it in this country for $40 per vial, in contrast with the wholesale price of $99.45 per 300 mg vial of the I.V. product. The cost for Marquest's Respirgard II nebulizer, which transforms the drug into an "aerosolized" form adds approximately $20 to the cost ("The Pink Sheet" Oct. 2, T&G-6). The group has responded to almost 100 requests for the drug to date and has bought up to three vials per patient request. The PWA Health Group is assuming a "wait and see" posture regarding the Lyphomed announcement and notes that the company has not set "specific" criteria or a starting date. The buying group plans to continue providing the drug until "the need disappears." Representatives from the group have spoken to FDA officials "on a regular basis" and report that they have received "no indication as of yet [from the agency] that there is a problem" regarding the group's importation practices.

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