Cork, Ireland (ots/PRNewswire) -
- INTELENCE is the first NNRTI to demonstrate antiviral activity
in patients with NNRTI-resistant virus -
Tibotec Pharmaceuticals, Ltd. announced today that the Committee
for Human Medicinal Products (CHMP) of the European Medicines Agency
(EMEA) has issued a positive opinion recommending conditional
approval of its HIV medication INTELENCE(TM) (etravirine) in the
European Union. Etravirine, also known as TMC125, is a next
generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and
the first to show efficacy in patients with NNRTI-resistant virus.
Etravirine is the first new NNRTI to be introduced in approximately
10 years. The conditional marketing authorisation from the European
Commission is expected in the coming months.
"We are encouraged by the positive opinion from the CHMP
regarding etravirine and will continue to work closely with
regulatory authorities to make it available to treatment-experienced
patients in Europe who are in need of new, well-tolerated treatment
options," said Roger Pomerantz, M.D., FACP, President, Tibotec
Research and Development.
The positive opinion from the CHMP, the committee responsible for
the scientific assessment of products, will be reviewed by the
European Commission, which then has authority to approve medicines
for use throughout the European Union.
The proposed indication for etravirine requires that it is used
in combination with a boosted protease inhibitor and other
antiretroviral medicinal products, and it will be indicated for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral treatment-experienced adult patients.
The CHMP's positive opinion is based on week 24 analyses from the
DUET studies -- two randomised, double-blind, placebo-controlled
phase III trials in highly pre-treated patients with NNRTI resistance
and protease inhibitor resistance. The DUET studies analysed the
efficacy and safety of etravirine in combination with an optimised
background regimen (OBR), which included darunavir/ritonavir. The
data showed that 58.9 percent of patients in the etravirine arm
achieved an undetectable viral load (less than 50 HIV-1 RNA
copies/mL) compared to 41.1 percent in the placebo arm [p<0.0001].
The results of DUET studies were published separately in two
articles in the 7 July 2007 issue of The Lancet.
Etravirine was developed by Tibotec Pharmaceuticals Ltd. and will
be marketed by Tibotec, a division of Janssen-Cilag in the European
Union. Janssen-Cilag International NV will hold the marketing
For additional information, please visit www.tibotec.com.
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.
Tibotec is a member of the Johnson & Johnson family of companies.
(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
the Company's expectations and projections. Risks and uncertainties
include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate
fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign health
care reforms and governmental laws and regulations; and trends toward
health care cost containment. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal year
ended December 30, 2007. Copies of this Form 10-K, as well as
subsequent filings, are available online at www.sec.gov, www.jnj.com
or on request from Johnson & Johnson. The Company does not undertake
to update any forward-looking statements as a result of new
information or future events or developments.)
MEDIA CONTACT: Hans Vanavermaete
Web site: http://www.tibotec.com
ots Originaltext: Tibotec Pharmaceuticals, Ltd.
Im Internet recherchierbar: http://www.presseportal.ch
Hans Vanavermaete of Tibotec Pharmaceuticals, +32(0)15-461-017
(office), or +32(0)478-44-72-78 (mobile)