Tibotec Pharmaceuticals Ltd.

TMC125 Demonstrates Significant Efficacy in Treatment-Experienced Patients with NNRTI Resistance in Phase III Trials

Cork, Ireland (ots/PRNewswire) - - Data Published in The Lancet on TMC125, an Investigational NNRTI from Tibotec TMC125 (etravirine, ETR), Tibotec's investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), demonstrated significant efficacy in patients with NNRTI resistance, according to the 24-week primary endpoint analysis from two ongoing, phase III studies published in the 7 July, 2007, issue of The Lancet. The studies, known as DUET-1 and DUET-2, examined the use of TMC125 in treatment-experienced HIV-1 patients with documented resistance to NNRTIs. TMC125 is the first NNRTI to show significant efficacy in patients with NNRTI resistance. These data will be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007), in Sydney, Australia, on 25th July, 2007. "NNRTIs have been an important component of antiretroviral therapy for treatment-naive HIV patients for more than ten years, but the development of NNRTI resistance has limited their use beyond this population," said Adriano Lazzarin, M.D., Vita-Salute, San Raffaele University, Milan, Italy. "The results from the DUET studies indicate an expanded role for this already well-understood and powerful class of antiretrovirals. The data suggest that TMC125 is the first sequenceable NNRTI for patients with resistance." DUET-1 and -2 Design The DUET studies are double-blind, placebo-controlled phase III trials designed to assess the efficacy, safety, and tolerability of TMC125 in treatment-experienced patients with documented evidence of NNRTI-resistance. Participants were randomized to receive TMC125 200 mg twice-daily or placebo, each given in addition to a background regimen (BR) including 600 mg darunavir, co-administered with 100 mg ritonavir, twice-daily, investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs) and optional use of enfuvirtide. Patients with HIV-1 who were eligible for the DUET trials had a viral load of greater than 5,000 copies/mL, were on a stable but failing antiretroviral therapy regimen, and had three or more primary protease inhibitor mutations at screening as well as evidence of NNRTI resistance, either at screening or from historical resistance tests. DUET-1 Results A total of 612 patients were randomised and treated in DUET-1 -- 304 in the TMC125 plus BR group and 308 in the placebo plus BR group. Results from the study showed that significantly more patients (56 percent; n=170) in the TMC125 arm achieved a confirmed undetectable viral load (less than 50 copies/mL), compared with those in the placebo arm (39 percent; n=119) [p=0.005]. The most commonly reported adverse events among patients receiving TMC125 vs. patients receiving placebo were rash (20.1 percent vs. 9.7 percent), nausea (13.8 percent vs. 12.3 percent) and diarrhea (11.8 percent vs. 20.5 percent). In addition, fewer patients receiving TMC125 vs. placebo experienced neuropsychiatric adverse events including nervous system disorders (15.1 percent vs. 19.8 percent) and psychiatric disorders (10.2 percent and 13.6 percent). In the TMC125 arm, 42 patients discontinued treatment for any reason vs. 56 patients in the placebo arm. The study results were released in a manuscript titled "24-week results of a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TMC125 in treatment-experienced HIV-1 infected patients: DUET-1." Manuscript authors are Jose Valdez Madruga, Pedro Cahn, Beatriz Grinsztejn, Richard Haubrich, Jacob Lalezari, Anthony Mills, Gilles Pialoux, Timothy Wilkin, Monika Peeters, Johan Vingerhoets, Goedele De Smedt, Lorant Leopold, Roberta Trefiglio and Brian Woodfall. DUET-2 Results In DUET-2, a total of 591 patients were randomised and treated -- 295 in the TMC125 plus BR group and 296 in the placebo plus BR group. Results from the study showed that significantly more patients (62 percent; n=183) in the TMC125 arm achieved a confirmed undetectable viral load compared with those in the placebo arm (44 percent; n=129) [p=0.0003]. The most commonly reported adverse events among patients receiving TMC125 vs. placebo were rash (13.9 percent vs. 9.1 percent), diarrhoea (18.3 percent vs. 20.3 percent) and nausea (13.9 percent vs. 9.8 percent). In addition, fewer patients receiving TMC125 vs. placebo experienced neuropsychiatric adverse events including nervous system disorders (14.6 percent vs. 17.2 percent) and psychiatric disorders (15.6 percent vs. 17.2 percent). In the TMC125 arm, 51 patients discontinued treatment for any reason vs. 73 in the placebo arm. The study results were released in a manuscript titled "DUET-2: 24 week results of a randomised double-blind trial to evaluate the efficacy and safety of TMC125 versus placebo in 591 treatment-experienced HIV-1 infected patients." Manuscript authors are Adriano Lazzarin, Thomas Campbell, Bonaventura Clotet, Margaret Johnson, Christine Katlama, Arend Moll, William Towner, Benoit Trottier, Monika Peeters, Johan Vingerhoets, Goedele De Smedt, Benny Baeten, Greet Beets, Rekha Sinha and Brian Woodfall. About Tibotec Pharmaceuticals Ltd. Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. About Tibotec Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa. This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and health care providers' specific needs in this disease domain. The company commercialise medicine against other viral diseases in the future. Contact: Karen Manson, mobile +32-479-89-47-99 ots Originaltext: Tibotec Pharmaceuticals Ltd. Im Internet recherchierbar: http://www.presseportal.ch Contact: Karen Manson, mobile, +32-479-89-47-99, for Tibotec Pharmaceuticals Ltd.

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