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MEPRON(TM) NOW AVAILABLE AS TREATMENT FOR PCP

 RESEARCH TRIANGLE PARK, N.C., Nov. 30 ~PRNewswire~ -- The Food and Drug Administration (FDA) has released for marketing the antiprotozoal drug Mepron(TM) brand atovaquone as a treatment for mild to moderate Pneumocystis carinii pneumonia (PCP), a common opportunistic infection in people with AIDS. The drug is indicated for individuals who are intolerant to trimethoprim~sulfamethoxazole (TMP~SMX).
 Mepron also received a Notice of compliance from Canada's Health Protection Branch (HPB) and is the first medication to undergo a joint, integrated review by the FDA and the HPB. PCP is the most common and frequently the first opportunistic infection to develop in people with HIV disease. It affects approximately 80 percent of people with AIDS during the course of their disease, and recurrences of the disease are common. Although most people who are properly treated with current therapies survive the first episode, some studies have shown a mortality rate of 15-20 percent.
 Currently, PCP can be effectively treated orally with TMP~SMX. However, as many as 50 percent of people with AIDS cannot take this medication because they experience significant side effects including rashes and lowered white blood cell counts (neutropenia), fever, nausea and vomiting.
 Pentamidine in injectable form is also used for the treatment of PCP, but its use is also associated with severe side effects in many patients.
 Clinical trials with Mepron
 Beginning in August 1990, Burroughs Wellcome conducted the largest controlled clinical trial of the treatment of PCP to date. This Phase II~III study compared Mepron (formerly 566C80) to TMP~SMX and concluded that the therapeutic success of Mepron was comparable to TMP~SMX. Therapeutic success was defined as sustained patient improvement over a four week period following therapy without having to discontinue medication because of adverse reactions.
 Dr. Walter Hughes of St. Jude Children's Research Hospital served as principal investigator of this study, which involved 322 patients with PCP at 37 sites throughout the United States, Canada and Europe.
 In the study, patients treated with Mepron had a higher rate of therapy failure due to lack of response than patients treated with TMP~SMX (17 percent versus 6 percent). However, patients treated with TMP~SMX had a higher rate of therapy failure due to toxicity than patients treated with Mepron (20 percent versus 7 percent). Survival was high in both groups after eight weeks but better in the TMP~SMX group (97 percent) than in the Mepron group (92 percent).
 A second clinical efficacy study compared the efficacy of Mepron to I.V. pentamidine in 134 patients suffering from mild to moderate PCP. Dr. Peter Frame of the University of Cincinnati served as principal investigator. The randomized, open-label trial showed that the two drugs were equivalent in terms of therapeutic success, with Mepron being better tolerated. Of the total patients studied, 29 patients taking I.V. pentamidine had to discontinue therapy due to adverse experiences, while only five patients had to discontinue Mepron.
 The most common side effects found in patients who have received Mepron to date are headache, nausea, diarrhea, rash, fever and elevated liver enzymes.
 New weapon to manage HIV disease
 Mepron has been available since November 1991, free of charge from Burroughs Wellcome, through a Treatment IND. To date, more than 900 individuals have received Mepron through this FDA mechanism and side effects observed have been consistent with those seen in clinical trials.
 "Since PCP is a life-threatening opportunistic infection, the availability of a new treatment for those who cannot take TMP~SMX represents another important step in Burroughs Wellcome's ongoing commitment to developing better and more effective therapies for the treatment of HIV," said Dr. David Barry, vice president of research, development and medical affairs at Burroughs Wellcome Co.
 Barry noted that Burroughs Wellcome first became involved in the fight against AIDS in 1980 when the company began receiving an unusual number of requests for a then experimental intravenous preparation of TMP~SMX to treat young men with PCP. "We were intrigued by these requests," Barry said, "because until that time, episodes of severe PCP generally occurred primarily in children who had received intensive chemotherapy for leukemia. Approximately one year later, epidemiologic studies revealed that PCP was one of the primary manifestations of AIDS."
 Activist involvement
 Barry said that Burroughs Wellcome has worked closely with patient advocates and activists over the course of the clinical trial program for Mepron, particularly on the Treatment IND.
 "Early access and rapid approval of atovaquone mean survival for thousands of people living with AIDS who face the life-and-death consequences of PCP," said David Peck, an AIDS treatment activist. Peck represented ACT UP~Boston and groups nationwide in successful negotiations with Burroughs Wellcome to make atovaquone widely available prior to FDA approval.
 Dosage and pricing information
 The recommended dosage of Mepron is 2250 mg.~day, administered as three 250 mg. tablets, three times a day for 21 days with meals. Clinical trials with Mepron have demonstrated that absorption of the drug is greatly enhanced when it is taken with food.
 The Burroughs Wellcome price to the wholesaler for a 250 mg. tablet will be $2.13, with a course of therapy at $402. This compares to $40-$115 for the older therapy TMP~SMX and $1,700 for intravenous pentamidine (not including hospitalization, outpatient or home infusion costs).
 In addition, Burroughs Wellcome announced that it would place a cap on the annual cost of Mepron for patients who require multiple courses of therapy. Under the program, patients who take more than 411 grams of Mepron a year and do not have third party coverage for such use will receive their medication, up to an additional 684 grams, at no cost the remainder of the 12-month period.
 Like all other Burroughs Wellcome medications for HIV disease, Mepron will be available at no cost to financially disadvantaged individuals who are not eligible for state and federal assistance programs or are currently in the process of applying for such programs and need interim assistance.
 Health care professionals, who initiate the enrollment process on behalf of patients, can call 1-800-722-9294 for more information.
 A research-based pharmaceutical company in Research Triangle Park, N.C., Burroughs Wellcome has a long, successful history of developing medications in the antiviral and infectious disease area. Burroughs Wellcome is a wholly-owned subsidiary of The Wellcome Foundation Ltd. (Wellcome plc), an international pharmaceutical company headquartered in London.
 Note: Full prescribing information available upon request.
 -0- 11~30~92
 ~CONTACT: Kathy Bartlett of Burroughs Wellcome, 919-248-4302~


CO: Burroughs Wellcome Company ST: North Carolina IN: MTC SU: PDT

CM-JM -- CH003 -- 4031 11~30~92 09:13 EST
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Date:Nov 30, 1992
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