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Executive Summary

LyphoMed's aerosolized pentamidine is headed for FDA approval as a Treatment IND for prevention of initial and recurring Pneumocystis carinii pneumonia (PCP) infection in AIDS patients. The agency telegraphed its intent to approve the product one week early and is expected to make the decision official on Feb. 6. LyphoMed currently markets an injectable form of pentamidine, Pentam 300, which is approved as a second line treatment for PCP. For some time, that injectable pentamidine has been reformulated and widely used as an aerosol in clinics for prevention of PCP in AIDS patients. As a result of that reformulated, off-label use, patient enrollment for controlled clinical trials has been a problem. The unapproved use of aerosolized pentamidine has become so prevalent that several health insurance companies have begun to pay for the treatment. Most recently, John Hancock recognized the use of the ad hoc reformulations and announced at the end of January that it would begin reimbursing for prophylactic use of aerosolized pentamidine treatment. The Treatment IND approval will put LyphoMed in an apparent awkward position of having to ask for permission to sell pentamidine for prophylactic use. The company's pentamidine I.V. has been prospering from the unlabeled use. A significant portion of the company's estimated existing annual sales of the product ($40 mil.) has been derived from the I.V. product being reformulated for aerosol administration. FDA may be going out on a limb with the approval. Neither LyphoMed nor Fisons, the two firms developing aerosol pentamidine products, have completed clinicals and submitted an NDA. The agency, however, is in a bind because of the difficulty that the unapproved reconstituted products present to continuing clinical trials. FDA is said to be working closely with the two companies to get the respective pentamidine products approved. Both expect to complete NDA submissions within the next four months. The choice of LyphoMed as a Treatment IND sponsor also shows a degree of regulatory courage at FDA. The agency has been arguing with LyphoMed about quality control issues for the better part of a year and has forced the firm at times to shut two of its three production facilities. To select the company for a Treatment IND leaves a noticeable opening for second-guessing by agency critics. However, FDA-watchers on Capitol Hill appear generally inclined to support FDA on the approval though they want to see a close post-approval followup on the product. The Treatment IND approval may indicate a lead for LyphoMed in the race for first full approval and the resulting seven-year market exclusivity under the Orphan Drug Act. FDA, however, has been asked by Sen. Kennedy (D-Mass) and Sen. Hatch (R-Utah) to withhold any grants of exclusivity during the first half of 1989. The orphan drug regulations are likely to be revisited by Congress during the first half of this year. LyphoMed's Treatment IND will be the third such approval for an AIDS-related drug, and the second for a PCP treatment. Earlier, Treatment INDs were granted to NIAID for Warner-Lambert's trimetrexate for the treatment of PCP and for Syntex' Cytovene ganciclovir for cytomegalovirus infections of the eye. Warner-Lambert recently reported that it has stopped active research into the PCP use for trimetrexate.

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