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Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
Date:11/1/2008

levels of TMC435 25 mg and 75 mg represented ~10 and >30-fold excess above the HCV replicon EC50 value, respectively.

Mean reductions of HCV RNA from baseline to day seven with TMC435 alone and in triple therapy were 2.63 and 3.47 log10 IU/mL, respectively, in the 25 mg arm, and 3.43 and 4.55 log10 IU/mL in the 75 mg arm. In the 75 mg four-week triple therapy arm, no viral breakthrough was observed; 9/9 patients achieved HCV RNA below lower limit of quantification (<25 IU/mL) and 8/9 patients achieved undetectable HCV RNA (<10 IU/mL) at day 28 (RVR=89 percent).

"These data provide important information about an emerging new approach to treating HCV," said Professor and Chairman Michael Manns, Hannover Medical School, Germany. "The discovery and development of new treatments is critical to improving the standard of care for the millions of people living with this disease."

As a global virology leader committed to patient care, Tibotec uses innovative science and expertise to research, develop, and manufacture, drugs for medical conditions with an unmet need. The company has successfully launched two antiviral medications for the treatment of HIV and is now building a portfolio of novel antiviral therapies for HCV with the goal of becoming a prominent leader in the treatment of this infectious disease.

TMC435 was discovered through a drug discovery collaboration between Medivir and Tibotec. Tibotec has the right to develop and commercialize the compound throughout the world, excluding the Nordic countries. In addition to TMC435, Tibotec has another PI in phase III development for the treatment of chronic HCV infection.

"Tibotec is committed to evaluating the safety and efficacy of TMC435 in clinical studies to determine its potential use in people with HCV," said Roger Pomerantz, M.D., president of Tibotec Research and Development. "This is an important step in our mission of addressing treatment challenges of infectious diseases, in
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SOURCE Tibotec BVBA
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