CORK, Ireland, June 27 /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.
About etravirine
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 authorisation.
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
+32(0)-15-461-017 (office)
+32(0)-478-44-72-78 (mobile)
Web site: http://www.tibotec.com
Hans Vanavermaete of Tibotec Pharmaceuticals, +32(0)15-461-017 (office), or +32(0)478-44-72-78 (mobile)
