Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adult...(ely 680 patients.To be eligible patients...),Health

Date:7/17/2008

ely 680 patients. To be eligible, patients must have a viral load greater than 5,000 copies/mL at screening and may not have taken any anti-HIV drugs prior to enrolling, as well as meet other screening criteria. The primary endpoint of the studies is to assess the proportion of patients with viral load < 50 copies/mL at week 48 on TMC278 vs. control (EFV). The studies will last for 104 weeks, which includes a four-week screening period, a 96-week treatment period and a four-week follow-up period.

Results from both of these studies will be submitted to the U.S. Food and Drug Administration (FDA) for consideration for approval of TMC278.

TMC278 is the third anti-HIV compound to be developed by Tibotec Pharmaceuticals. Tibotec Pharmaceuticals is also developing other investigational compounds for the treatment of hepatitis C and tuberculosis.

For additional information on inclusion and exclusion criteria for both of these studies, please see http://www.clinicaltrials.gov or email info@tibbe.jnj.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.

Forward Looking Statement

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 Tibotec's expectations and projections. Risks and uncertaint
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SOURCE Tibotec Pharmaceuticals Ltd. Copyright©2008 PR Newswire. All rights reserved

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