Development of anti-virals for AIDS may be speeded bymonths, and perhaps years, through an unprecedented sharingof supplies and information during early clinical testing ofcompounds from 15 pharmaceutical companies.
The development, long recommended by AIDS activists, tookmore than a year of formal negotiations to forge betweenrepresentatives of American and European pharmaceuticalcompanies. Industry leader Merck & Co. Inc. initiated thediscussions, which resulted in the Inter-Company Collaborationfor AIDS Drug Development. The alliance will hold its firstmeeting this summer so each company can present details ofthe compounds it is developing. The group's top researchscientists expect to meet about six times a year. Allpharmaceutical companies actively involved in HIV anti-viraldevelopment are eligible to join the collaboration.
Since results of a recent study indicate the only approved solotreatment for HIV infection, AZT, apparently loses effectivenessin about a year as the virus gains resistance, HIV treatment isshifting to combination therapies. Anti-virals ddI and ddC havereceived FDA approval for use in combination with AZT.
Patients may one day rotate through a variety of anti-viraltreatments over time while researchers investigate whichcombinations are the most promising, said Edward Scolnick,president of Merck's research labs. The collaboration alsolowers the risk of losing promising drugs "because in isolationthe drug doesn't look very good," added Jeffrey Laurence, asenior scientist with the non-profit American Foundation forAIDS Research.
The availability of more compounds to use in combination toovercome HIV drug resistance was an impetus for forming thecollaboration, Merck spokesman John Doorley told BioWorld.
He said comparisons of early clinical data will enable thecompanies to "learn something new" and "should increaseefficiency and competitiveness" since companies should knowafter early clinical trials how their potential treatment appearsto stack up.
The companies believe they will not encounter antitrustproblems because they will not share commercial aspects. Thecompanies will not share information about basic research, sothe drugs they develop will remain exclusively theirs.
The collaboration also excludes exchanging information fromlarge-scale clinical trials designed to confirm safety andefficacy. The companies will retain responsibility for all theirclinical trials, although assays for drug concentration or viralload could be standardized to allow comparisons of earlytesting.
Vaccines were not included, Doorley said, because they are"still at a basic research stage."
Most of the anti-virals inhibit either transcription of the virus'genes or one of the other seven enzymes that comprise its lifecycle. The 15 companies participating are: AB Astra of Sweden;Boehringer Ingelheim, Miles Inc. and Hoechst AG of Germany;Bristol-Myers Squibb Co., Du Pont Merck, Merck & Co. Inc., EliLilly and Co., Pfizer Inc., and Syntex Corp. of the U.S.; GlaxoHoldings plc, Burroughs-Wellcome Co. and SmithKline Beechamplc of Britain; Hoffmann-La Roche of Switzerland; and SigmaTau of Italy.
This is the first broad collaboration on AIDS therapies, butpharmaceutical companies have worked together to respond toother public health crises, such as perfecting mass-productionof penicillin during World War II, polio vaccine in 1951 and aGerman measles vaccine in 1965. -- Nancy Garcia
(c) 1997 American Health Consultants. All rights reserved.