Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE

    WASHINGTON, Jan. 31 /PRNewswire/ -- The FDA approved Tibotec
 Pharmaceutical's novel non-nucleoside reverse transcriptase inhibitor
 (NNRTI) INTELENCE(R). The company also announced introductory pricing for
 the eagerly anticipated new compound at $21.80 per day, substantially lower
 than other recently introduced antiretrovirals.
 
     "The efficacy that INTELENCE (TMC125/etravirine) has shown in the DUET
 studies is impressive. INTELENCE is an important new HIV medication that,
 for the first time, re-opens the NNRTI class to patients with
 NNRTI-resistant virus," stated Donna Christian-Chistensen, MD, Chair of the
 Congressional Black Caucus Health Brain Trust and TIICANN board member. "We
 applaud Tibotec for its efforts to make this innovative new medication
 available and accessible to people living with HIV."
 
     In the Duet study, 612 patients were randomized and treated (304 in the
 TMC125 group, 308 in the placebo group). At week 24, 170 (56%) patients in
 the TMC125 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 TMC125 were generally comparable with
 placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30
 [10%] on placebo) and diarrhea (36 [12%] patients on TMC125 vs 63 [20%] on
 placebo).
 
     "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 TIICANN. "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."
 
     "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, TIICANN's Chair. "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."
 
     Congressman Maurice Hinchey, a TII CANN Board member stated:
 "Representing New York, which continues to bear the largest portion of the
 many burdens of the American AIDS epidemic, I'm very sensitive to any
 efforts to make new treatments affordable and accessible to all regardless
 of their financial circumstances or health insurance coverage. No HIV+ or
 AIDS patient should be denied access to critical drugs that can help them
 live longer and more productive lives."
 
     Contact: Bill Arnold (202) 588-1775
 
 
 

SOURCE The AIDS Institute