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AIDS CLINICAL TRIAL COLLABORATION BY 15 DRUG COMPANIES

Executive Summary

AIDS CLINICAL TRIAL COLLABORATION BY 15 DRUG COMPANIES will focus on cooperation in the development of combination antiviral therapies. Collaboration has become a "plausible" idea with "the realization that the virus will likely develop resistance to every HIV antiviral compound," Merck, the company that proposed the cooperative effort, remarked in announcing the collaboration on April 19. The 15 participating firms are Astra, Boehringer Ingelheim, Bristol-Myers Squibb, Burroughs Wellcome, DuPont Merck, Glaxo, Hoechst AG, Hoffmann-La Roche, Lilly, Merck, Pfizer, Miles (on behalf of its parent firm Bayer AG), Sigma-Tau, SmithKline Beecham and Syntex. All the companies participating in the "Inter-Company Collaboration for AIDS Drug Development" have antiviral compounds for AIDS either in or nearing clinical trials. At this time, the collaboration is limited to antiviral therapeutic agents and does not include any vaccines. Goals of the effort include sharing information indicating which HIV antiviral compounds may be most appropriate to test in combination; coordinating the sharing of antiviral compounds between companies for use in combination or comparative clinical trials considered appropriate; promoting the concomitant testing of antivirals that together may delay or eradicate drug resistance; and working to standardize tests used in preclinical development. In focusing the collaboration chiefly on the early clinical development of compounds -- Phase II -- the firms avoid antitrust concerns that could potentially arise from cooperation on earlier stage work. The governing body of the collaboration is a "board of participants" with one representative from each firm, usually the research head. Week-to-week operations will be overseen by the management committee, which will be a subset of the board. The group will also have scientific, legal and communications subcommittees. In most cases, members of the scientific subcommittee will be the company heads of antiviral research. Merck Chairman Roy Vagelos proposed a collaboration in the development of AIDS drugs to CEOs of "major" U.S. and European companies at a meeting in April 1992, Merck said. Last summer, corporate Exec VP and Merck Research Labs President Edward Scolnick, MD, sent out a proposal to about 29 firms with antivirals under development asking whether the firms would be willing to collaborate on basic research and/or late animal and early clinical trials. Only one or two of the firms asked were willing to share basic research, Merck added. Rhone-Poulenc Rorer and Wyeth-Ayerst both were involved in the formation of the collaborative group but dropped out because their antivirals are not close enough to clinical trials. Upjohn and Abbott chose not to join the group. The group plans to convene for the first time within about two months, and to meet about six times a year or more thereafter. The signing of the collaborative agreement was announced four days before a scheduled demonstration against PMA by AIDS activists. ACT-UP groups from around the U.S. protested at PMA headquarters on April 23, where about 150-200 demonstrators faced a police line. PMA closed its offices in anticipation of the protest but issued a statement saying that "the PMA AIDS Task Force, consisting of companies involved in AIDS research, is now reviewing ACT-UP's positions and requests."
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