January 23, 2008 ADAP Advocacy Association Commends Tibotec Pharmaceuticals for its FDA-Approved “Intelence”®; Pricing of New HIV Medicine Further Applauded For Immediate Release WASHINGTON, D.C. (January 23, 2008) – The ADAP Advocacy Association, also known as aaa+, today commended Tibotec Pharmaceuticals for its new anti-HIV Medicine, Intelence ®, which received accelerated approval by the Food & Drug Administration (FDA) on January 18th.  aaa+ joined the Fair Pricing Coalition in further welcoming Tibotec’s decision to establish an introductory pricing schedule below other antiretrovirals. "As a long time member of the Fair Price Coalition, I must recognize the transparency, understanding and respect exhibited by Tibotec in its relations with the HIV/AIDS community," said Bill Arnold, Executive Director of the Title II Community AIDS National Network (TIICANN) and aaa+ co-chair. "It is remarkable that Tibotec remains collegial in the broadest sense of that word in the face of the challenges being faced by its parent company, Johnson & Johnson." Intelence (etravirine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.  This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of Intelence. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.1 "As a patient with a remarkably low tolerance for most antiretrovirals, I have always depended on NNRTIs as the base of my regimens," admitted Gary Rose, aaa+ board member. "It is a major relief for me to have a new option as my present regimen combining an NNRTI and a protease inhibitor which is both toxic and weakening. I think this is quite a common phenomena among patients with long-term exposure to antiretrovirals and so Tibotec’s determination to develop new, non-cross resistant drugs for HIV, and just as importantly, oral compounds for hepatitis C – the company’s dedication to virology is notable – is a cause for quiet celebration among infectious disease doctors and my fellow patients." In the Duet study, 612 patients were randomized and treated (304 in the Intelence group, 308 in the placebo group). At week 24, 170 (56%) patients in the Intelence group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9–25; p=0•005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with Intelence were generally comparable with placebo, with the exception of rash (61 [20%] patients on Intelence vs 30 [10%] on placebo) and diarrhea (36 [12%] patients on Intelence vs 63 [20%] on placebo). Stated aaa+ co-chair, Philip A Haddad, MD: "As a physician, I cannot stress the importance of being able to reassure my patients living with HIV/AIDS about the availability of further treatment options especially when we are confronted with the failure of the ongoing therapy.  Tibotec’s Intelence offers to those patients who have developed resistance renewed hope of living a disease free life. There is nothing that kindles this hope more than the knowledge that we still have at our disposal a drug like Intelence that can still work in such a bleak situation." aaa+ promotes and enhances the AIDS Drug Assistance Programs (ADAPs) and improves access to care for persons living with HIV/AIDS.  aaa+ works with advocates, community, health care, government,  patients, pharmaceutical companies and other stakeholders to assure that access to services recognize and afford persons living with HIV/AIDS to enjoy a healthy life. For more information about aaa+ please visit www.adapadvocacyassociation.org. For inquiries please contact Brandon M. Macsata by phone at (305) 519-4256 or email at info@adapadvocacyassociation.org, or William Arnold by phone at (202) 588-1775 or email at weaids@tiicann.org.   1 Tibotec Therapeutics, a division of Ortho Biotech Products, “FDA APPROVES INTELENCETM (etravirine) FOR HIV COMBINATION THERAPY,” January 18, 2008.  #### ADAP Advocacy Association (aaa+) 1501 M Street, NW - 7th Floor • Washington, DC 20005 © Copyright 2007 - All Rights Reserved