Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 10 - November, 1993
Derek Link

Burroughs Wellcome, a North Carolina-based drug company, sponsored a forum at the 1993 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to discuss their plans to seek over-the-counter approval for 200mg acyclovir tablets. Acyclovir (Zovirax) is an approved treatment for genital herpes virus infections. Approximately one-quarter of the American population is infected with HSV- 2, the virus that causes genital herpes. Acyclovir, which is Burroughs Wellcome's top-selling drug, is presently available only by prescription in the United States. A topical cream form of acyclovir was recently approved for over-the-counter use in the United Kingdom. But can patients with previously diagnosed genital herpes distinguish recurrences from other ulcerative sexually transmitted diseases (STD), such as syphilis or chancroid? And would inapproporiate use of acyclovir encourage drug-resistance? Gray Davis, M.D., a Burroughs Wellcome researcher, reported that data from previous studies show that patients can correctly identify recurrences over 97 percent of the time. As for resistance, no one knows.

GP160 Vaccine Saga Grinds On; Single Product Trial Unlikely

In a victory for GP160 opponents, the deadline for a decision on the controversial single-agent trial of the MicroGeneSys GP160 therapeutic vaccine has been extended to April 1994 by a House-Senate conference committee. MicroGeneSys, a Connecticut-based biotechnology company, helped by the lobbying efforts of former Senator Russell Long, received a $20 million Congressional earmark for the Department of Defense to study its product last year. The earmark, which is believed to be the first product-specific research allocation ever made by Congress, caused an outcry by many scientists and AIDS activists who protested political interference in scientific priority setting. The earmark officially remains in limbo until the FDA, NIH, and Department of Defense (DOD) agree on how the money should be spent, but most observers agree that the recent Congressional action is a set-back for MicroGeneSys. Both FDA and NIH are on record as opposed to a single agent GP160 trial. Kristine Gebbie, the White House "AIDS czar," who also opposes the single product trial, is pressing the DOD to follow suit. Since MicroGeneSys refuses to supply their vaccine to a multi-product trial, Gebbie and others propose that the money be used to fund basic AIDS research.

Bristol Myers Plans D4T Filing by End of Year

In a meeting with AIDS activists, Bristol Myers Squibb, a New York-based drug company, announced plans to file a New Drug Application (NDA) for D4T, a anti-HIV reverse transcriptase inhibitor, by the end of 1993. In addition to pharamacologic and safety data on the drug, the NDA will include efficacy data from a three-arm randomized comparison of D4T in 150 patients, and a two-arm randomized comparison of AZT and D4T in 832 patients. Data from the D4T Expanded Access Program, which enrolled over 9000 patients, and a European dose comparison study of the drug, will also be included in the submission. Initial efficacy claims will be based on surrogate markers, predominately CD4 cell responses. Clinical endpoint data on the drug are not expected until at least early 1994.

Roche Sales Up 15 percent, But Claims Research Spending Too High

Roche, the Swiss drug company with a New Jersey-based affiliate that makes ddC, reported a 15 percent increase in pharmaceutical sales in the first nine months of 1993, equivalent to $4.1 billion. Roche described the performance of its pharmaceutical division as "particularly satisfying." However, according to a report in Scrip, a pharmaceutical industry newsletter, Jurgen Drews, head Research and Development (R&D) for Roche, stated that research spending in the pharmaceutical industry was too high given the present cost-conscious climate. Drews, who made the comments at a press conference in Switzerland, suggested that this research money could be more profitably invested elsewhere. Roche presently invests 24 percent of sales into R&D, one of the highest rates in the industry. According to the report, Roche's R&D budget will be reduced to 17 to 18 percent of sales over the coming years by slowing its rate of growth in relation to sales. Scrip also reports that RO-31-8959, Roche's HIV protease inhibitor, was highlighted by Drews as a priority compound for the company.
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