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SAFETY PROFILE OF NEW ANTI-PNEUMOCYSTIS DRUG GIVEN BOOST BY DATA PRESENTED AT IX INTERNATIONAL AIDS CONFERENCE

 BERLIN, Germany, June 9 /PRNewswire/ -- The safety profile of the drug atovaquone in treating AIDS-related Pneumocystis carinii pneumonia (PCP) has been further bolstered by results from a 13-month Treatment Investigational New Drug (TIND) program presented today at the IX International Conference on AIDS.
 A Burroughs Wellcome Co. researcher reported that in 940 AIDS patients who received the drug through the TIND program as treatment for PCP, no serious unexpected drug-related side effects were seen. An opportunistic infection, PCP continues to be one of the leading causes of death in patients with AIDS.
 Treatment INDs, sometimes referred to as expanded access programs, provide patients in the United States with life-saving medications prior to their release for marketing by the U.S. Food & Drug Administration. The TIND ran from November 1991 to December 1992. The drug, known as Mepron(R), was released for marketing in November 1992 as a treatment for mild to moderate cases of PCP in AIDS patients who can't tolerate the side effects of therapy with trimethoprim/sulfamethoxazole (TMP/SMX).
 "The safety data gathered through this TIND are important in that they confirm the drug's safety profile as observed in clinical trials," said Alice White, Ph.D., the study presenter and senior epidemiologist at Burroughs Wellcome Co.
 Of the 940 patients evaluated through this program, 793 were treated for mild to moderate cases of PCP through the TIND. A parallel open- label program provided medication to the 147 patients with severe PCP who comprised the
remainder of the study population. The open-label protocol was evaluated as a separate data set as Mepron is not indicated for the treatment of severe cases of PCP. However, those patients also received free medication and were followed in the same way as the TIND group.
 From this entire study population, no reports of unexpected life- threatening side effects attributable to Mepron were filed by treating physicians. Though generally mild, side effects associated with Mepron include rash, nausea, diarrhea, fever and abnormal liver function.
 Safety data generated from a TIND are considered important because they may be more representative of clinical practice and include a more diverse patient population than clinical trials. In clinical trials, safety data are accumulated from patients who meet narrowly defined qualification standards. As a result of the more "real world" population in a TIND, this study design is considered a good indicator of potential safety problems that might occur after a drug is marketed.
 Furthermore, this TIND provided researchers the opportunity to study the safety of Mepron in patients with severe PCP. Prior to this program, very little was known about the safety of Mepron in this patient population because the drug had not been studied in those cases.
 In the TIND, clinical response to therapy with Mepron was reported by physicians in 78 percent of the mild to moderate cases of PCP, and in 56 percent of the severe cases. Also, 77 percent of the TIND cases were able to complete the 21-day treatment cycle with Mepron, while 66 percent of patients with severe PCP were able to finish their treatment cycle.
 The mild side effect profile associated with Mepron make it an effective alternative for patients with PCP who can't take TMP/SMX. In the May 27 issue of The New England Journal of Medicine, researchers reported that while TMP/SMX is more effective than Mepron in fighting PCP, many patients discontinue treatment with TMP/SMX due to severe side effects. The study went on to say that even though Mepron was slightly less effective in fighting PCP, it was tolerated by a greater percentage of patients than was TMP/SMX.
 Mepron was developed by Burroughs Wellcome Co., a research-based pharmaceutical company with headquarters in Research Triangle Park, N.C. The company is a member of the Wellcome Group which discovers, develops, produces and markets quality healthcare products worldwide.
 -0- 6/9/93
 /EDITOR'S NOTE: Product is pronounced MEH-pron, emphasis on first syllable/
 /CONTACT: Kathy Bartlett, 919-248-4302, or Doug Stokke, 919-248-8611, both of Burroughs Wellcome/


CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:

CM -- CH001 -- 6882 06/09/93 09:04 EDT
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Date:Jun 9, 1993
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