LYPHOMED's PENTAMIDINE NDA ON "FAST TRACK" AT FDA

Executive Summary

LYPHOMED's PENTAMIDINE NDA ON "FAST TRACK" AT FDA with approval of the orphan drug anticipated for this summer, the firm's chairman John Kapoor indicated in his presentation to the Alex Brown Health Care seminar on May 21. Noting that pentamidine is used in the treatment of AIDS related Pneumocystis carinii pneumonia, Kapoor reported that LyphoMed received orphan status "about a month ago for this drug." Kapoor said that "the NDA is proceeding on the fast track through FDA and we hopefully will have an NDA [approval] in the next couple of months." Kapoor said that LyphoMed chose to supply the compound after receiving a call "six months ago" from the Centers of Disease Control (CDC). "We were able to deliver the product to them in six weeks and as a result they asked us to file for orphan drug status," Kapoor explained. In its most recent Morbidity and Mortality Weekly Report for May 18, CDC announced the availability of pentamidine under LyphoMed's IND. Up until now, CDC had distributed a foreign produced pentamidine manufactured by May & Baker. The LyphoMed exec explained that the firm will get increased exposure in the hospital market through sale of the orphan drug. "This product will probably be sold to every major institution in the country," Kapoor declared, "That's part of our strategy." A mfr. of micronutritionals and critical care injectable drugs for intravenous use, the Melrose Park, Illinois-based firm had sales of nearly $20 mil. in 1983 -- up from $6.3 mil. in 1981. Kapoor projected LyphoMed's 1984 sales to be in the "$28 mil.-$30 mil. range." The firm said in its recently released annual report for 1983 that it has received approval for 24 drug applications, "and 21 additional drug applications have been submitted and are awaiting approval." Currently under development, Kapoor said, are nitroglycerin IV, dopamine, glucagon, protamine, succinylcholine (B-W's Anectine), and bretylium tosylate (American Critical Care's Bretylol). Kapoor also noted that LyphoMed successfully raised nearly $13 mil. in 1983, via its initial public offering, for expansion of the firm's production facilities. "Right now, 30% of our units are being made by outside sources, which is very expensive," Kapoor said. "As soon as the plant is ready we're going to bring all that product in-house." He predicted that the plant would be completed this summer.