Date: Mon, 7 Apr 1997 09:26:02 -0400 (EDT) From: ACT UP/Golden Gate To: Multiple recipients of list Subject: Delavirdine approved by FDA!!! FOR IMMEDIATE RELEASE FOR MORE INFORMATION April 7, 1997 Rob Sabados: (415)252-9200 ACT UP/Golden Gate: (415)252-9200 ACT UP/Golden Gate members cheer approval of new AIDS drug; commend company for responsible pricing ACT UP/Golden Gate hailed today's announcement that the Food and Drug Administration (FDA) has approved Pharmacia & Upjohn's new anti-HIV drug, delavirdine, also known as Rescriptor. Delavirdine is the second in a new class of antiviral drugs, called NNRTIs, to be approved and is the only NNRTI approved for use with protease inhibitors. The FDA's decision follows months of uncertainty resulting from a November, 1996, hearing at which the FDA's Antiviral Drug Advisory Committee was unable to reach a decision regarding approval. Afterwards, ACT UP/Golden Gate organized and led a national coalition that helped persuade the FDA to approve delavirdine. "Delavirdine's approval is a real victory for people with AIDS," commented ACT UP/Golden Gate member Mike Donnelly, who uses delavirdine as part of combination therapy. "When I added delavirdine to my current regimen, it provided the extra kick needed to make my viral load undetectable." ACT UP/Golden Gate praised the company's decision to make delavirdine one of the least expensive antiviral drugs on the market, with a wholesale acquisition cost of $2,250 per year and an average wholesale price of $2,700 annually. The company states that the annual cost to patients will be between these two prices. ACT UP/Golden Gate member and delavirdine user Matthew Sharp stated that "We're pleased that Pharmacia & Upjohn priced delavirdine more affordably than other recently approved antiviral drugs. Pharmacia & Upjohn chose not to follow the industry practice of making an obscene profit at the expense of people with AIDS. The company's responsible behavior should serve as a model to drug companies that place profit above the lives of people with AIDS." ACT UP/Golden Gate spearheaded a national coalition that company officials credit with playing an important role in the drug's approval. In November, 1996, the FDA's Antiviral Drug Advisory Committee was unable to reach a decision on the drug's approval, despite the strong support of ACT UP/Golden Gate member Rob Sabados. Following the hearing, ACT UP/Golden Gate wrote a community consensus letter supporting delavirdine's approval, which was signed by thirty-five nationally recognized AIDS organizations, physicians, and treatment advocates. The letter was presented to senior FDA officials at a January, 1997, meeting between the FDA and a broad spectrum of national community groups and which was organized and attended by ACT UP/Golden Gate and the San Francisco AIDS Foundation. The activist group also organized phone, fax, and e-mail zaps of the FDA to remind agency officials of the importance of delavirdine to the AIDS community. During the 1996 Vancouver AIDS conference, ACT UP/Golden Gate secured a commitment from Pharmacia & Upjohn to inform physicians of the effect of combining delavirdine with protease inhibitors. While delavirdine can be safely used with protease inhibitors, the company has made specific recommendations regarding monitoring and dose-adjustment. Following several weeks of discussions with ACT UP/Golden Gate, Pharmacia & Upjohn sent the letter to physicians and AIDS service organizations. The activist group called upon the company, the FDA and the federal Pediatric AIDS Clinical Trials Group (PACTG) to take immediate steps to make delavirdine available to children. During the 1997 Retroviruses conference in Washington D.C., Pharmacia & Upjohn agreed to implement a pediatric expanded access program as soon as pharmacokinetic and safety data was available from a planned PACTG study of delavirdine. "We're tired of the delays and fingerpointing. We demand that FDA, National Institutes of Health, and Pharmacia & Upjohn explain to the community why there are no pediatric studies of delavirdine underway," commented ACT UP/Golden Gate and FDA Antiviral Advisory Committee member Bill Thorne. *** ACT UP/Golden Gate is an all-volunteer, non-profit organization dedicated to the improvement of treatments, social services and healthcare access for people with HIV/AIDS, and breast cancer. The vast majority of ACT UP/Golden Gate members are HIV-infected or cancer survivors themselves. The group is committed to negotiation and focused, non-violent direct action to ensure that drug companies, researchers, AIDS organizations and government officials address the needs of people with HIV-infection and breast cancer. ACT UP/Golden Gate accepts no pharmaceutical company money and holds weekly public meetings open to any person affected by HIV or breast cancer who wishes to attend. ACT UP/Golden Gate is not affiliated with the group of individuals using the name "Act up San Francisco." *----------------------------------------- To contact ACT UP/Golden Gate: * 519 Castro Street #93 * San Francisco CA 94114 * * Phone: (415)252-9200 * FAX: (415)252-9277 * * e-mail:actup@actupgg.org * web: http://www.actupgg.org * ACT UP/Golden Gate is not affiliated with "Act up San Francisco"