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.de

Contact:
Karen Manson, mobile, +32-479-89-47-99, for Tibotec Pharmaceuticals
Ltd.


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