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FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF MYCOBUTIN(TM) FOR THE PREVENTION OF AIDS-RELATED INFECTION

 FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF MYCOBUTIN(TM)
 FOR THE PREVENTION OF AIDS-RELATED INFECTION
 DUBLIN, Ohio, Sept. 24 /PRNewswire/ -- The U.S. Food and Drug Administration Antiviral Drug Advisory Committee today recommended that MYCOBUTIN(TM) (rifabutin) be approved for the prevention of disseminated Mycobacterium avium complex (MAC) in people with AIDS (PWAs) or advanced HIV. Mycobutin has been co-developed by Adria Laboratories and Farmitalia Carlo Erba, both members of the Ferruzzi-Montedison Group (NYSE: MNT).
 If approved by the FDA, Mycobutin would be the first drug available for use as prophylaxis against MAC, a life-threatening bacterial opportunistic infection common among people with advanced AIDS. MAC is commonly found in the environment and is a threat to people whose immune systems have been weakened by HIV. Recent studies have found that MAC infects 50 percent of all PWA's 2-1/2 years after their AIDS diagnosis, and is believed to be a major cause of wasting syndrome among PWAs. MAC symptoms include severe diarrhea, persistent fever and night sweats. Disseminated MAC infection decreases life expectancy.
 "We are pleased with the committee's recommendation, and view this as an important step in making Mycobutin available to people with AIDS," said Joseph Bianchine, M.D., Ph.D., vice president, director, Medical Research Center, Adria Laboratories. "We believe that Mycobutin will play an important role in preventing disease, improving quality of life, and hopefully survival in PWAs."
 In clinical trials, patients on placebo were two to three times more likely to develop MAC as were patients taking Mycobutin. Mycobutin was found to be safe and very well tolerated even in patients who received the drug for up to two years. The Mycobutin trials were the first large-scale studies to be conducted involving community based research groups, such as the Community Research Initiative on AIDS. These community groups were established to address the need for rapid clinical testing of experimental therapies for HIV disease.
 Mycobutin is currently available under an expanded access program (Treatment IND) for people with AIDS and a CD4 cell count of 200 or less.
 Adria Laboratories is a research oriented company focused in oncology and AIDS-related areas.
 Adria Laboratories and its sister company Farmitalia Carlo Erba are both Montecatini companies and part of the Ferruzzi-Montedison Group.
 Ferruzzi-Montedison is a leading international industrial group which operates in the chemical, pharmaceutical, energy and agro- industrial sectors, with worldwide aggregate turnover of over $25 billion.
 -0- 9/24/92
 /CONTACT: Bethany A. Beck of Adria Laboratories, 614-764-8162, or Marcie Kennedy of Ferruzzi-Montedison, 212-997-7022/
 (MNT) CO: Adria Laboratories; Ferruzzi-Montedison ST: Ohio, New York IN: MTC SU:


TM-OS -- NY063 -- 3254 09/24/92 16:06 EDT
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Publication:PR Newswire
Date:Sep 24, 1992
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