Tibotec Pharmaceuticals Ltd.

Tibotec Begins Enrollment in Europe for Phase III Trial of Telaprevir in HCV Patients who Failed Prior Treatment

    Cork, Ireland, November 20 (ots/PRNewswire) -

    - Telaprevir Data Presented at AASLD

    Tibotec BVBA today announced that it has begun enrolling patients in its phase III study of telaprevir (VX-950), an investigational protease inhibitor (PI), in patients with chronic genotype 1 hepatitis C virus (HCV) for whom the current standard treatment has not been successful. Tibotec is managing the global trial, which is being conducted at more than 50 sites in Europe. In addition, nine presentations on telaprevir were presented recently at the American Association for the Study of Liver Disease's (AASLD) Liver Meeting 2008 in San Francisco, California, 31 October - 4 November, 2008. Tibotec presented interim findings from its exploratory phase II study, VX950-C208, evaluating telaprevir administered every eight hours or every 12 hours, in genotype 1 treatment-naïve HCV patients. Data showed that the majority of patients in four telaprevir-based treatment arms achieved an undetectable viral load by week four and week 12 of treatment. Telaprevir is being co-developed by Vertex Pharmaceuticals, Inc. and Tibotec.(i)

    The current standard of care for HCV, pegylated interferon (Peg-IFN) combined with ribavirin (RBV), is effective in thirty to fifty percent of patients with genotype 1 HCV, demonstrating a significant need for new therapeutic approaches.(ii)Currently, there are no effective treatment regimens for patients who have failed standard treatment.(iii) The REALIZE study (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes), which compares the efficacy, safety, and tolerability of telaprevir combined with Peg-IFN alfa-2a plus RBV, versus Peg-IFN alfa-2a and RBV alone, is the first phase III trial to study a direct antiviral treatment for HCV in patients who do not respond to standard of care therapy.(i)

    "The phase III trial will give us essential information about the safety and efficacy of a telaprevir-based regimen in patients who otherwise would have no recourse when standard treatment fails," said Roger Pomerantz, M.D., president of Tibotec Research and Development. "We also are proud to present phase II data that show a strong therapeutic response in treatment-naïve patients. We look forward to continuing to develop telaprevir and working with health authorities to make it available to patients."

    About Telaprevir Phase II Data in Treatment-Naïve Patients

    Interim data from Tibotec's exploratory phase II study, VX950-C208, of telaprevir in treatment-naïve patients with HCV genotype 1 were presented recently at AASLD. The ongoing, open-label, randomized study evaluated telaprevir administered every eight hours or every 12 hours in combination with Peg-IFN alfa-2a or -2b and RBV in treatment-naïve patients with genotype 1 HCV.(i) An interim analysis showed that the majority of patients in all four treatment arms achieved an undetectable viral load by week four and week 12.(i)

@@start.t1@@      Week four results(i):
      - Sixty-nine percent taking telaprevir 750 mg every eight hours with
         alfa-2b and RBV
      - Eighty percent taking telaprevir 750 mg every eight hours with alfa-2a
         and RBV
      - Sixty-seven percent taking telaprevir 1125 mg every 12 hours with
         alfa-2b and RBV
      - Eighty-three percent taking telaprevir 1125 mg every 12 hours with
         alfa-2a and RBV
      Week 12 results(i):
      - Ninety-three percent taking telaprevir 750 mg every eight hours with
         alfa-2b and RBV
      - Ninety-three percent taking telaprevir 750 mg every eight hours with
         alfa-2a and RBV
      - Eighty-five percent taking telaprevir 1125 mg every 12 hours with
         alfa-2b and RBV
      - Eighty-three percent taking telaprevir 1125 mg every 12 hours with
         alfa-2a and RBV@@end@@

    When the study reached week 12, patients on telaprevir-based therapy received either 12 or 36 additional weeks of Peg-IFN with RBV, depending on the patients' virological response.(i)

    Adverse events (AEs) reported in this trial were consistent with those observed in earlier studies.(i) Overall, the incidence of any AE reported in greater than 25 percent of subjects in any group (regardless of severity and causality) was comparable between the four treatment arms.(i) Serious AEs leading to permanent treatment discontinuation were mainly due to rash- and anemia-related events.(i) Rash and anemia events were reversible upon cessation of treatment.(i)

    Additionally, recent telaprevir data from studies led by Vertex were also presented at AASLD, including the final results of the PROVE 2 study. PROVE 2 is a phase 2b clinical trial that examined telaprevir in combination with Peg-INF-alfa-2a with or without RBV in treatment-naive genotype 1 HCV patients at 28 clinical centers throughout Europe.

    In addition to the REALIZE trial currently underway, telaprevir is now being studied in treatment-naïve patients in a phase III trial program called ADVANCE, led by Vertex.

    About the REALIZE Phase III Study

    REALIZE is a randomized, placebo-controlled, double-blind study that will compare the efficacy, safety, and tolerability of two regimens of 750 mg telaprevir every eight hours (with and without a delayed start) combined with Peg-IFN alfa-2a plus RBV, versus Peg-IFN alfa-2a and RBV alone. Six hundred fifty patients with genotype 1 HCV who have failed prior treatment with Peg-INF and RBV are enrolled in REALIZE, which will be conducted over 72 weeks. Patients belong to one of the three following groups:

@@start.t2@@      - Null responders (achieved less than a 2 log reduction in RNA at week 12
         of prior therapy)
      - Partial responders (achieved at least a 2 log reduction at week 12, but
         failed to achieve undetectable HCV RNA by week 24 of prior therapy)
      - Relapsers (achieved an undetectable HCV RNA at the completion of at
         least 42 weeks of prior treatment, but relapsed during follow-up)@@end@@

    The primary endpoint is sustained virologic response (SVR), defined as undetectable HCV genotype 1 RNA (<10 IU/mL) 24 weeks after the completion of treatment. SVR is considered a cure for people with HCV.

    For additional information on the inclusion and exclusion criteria for this study, please see http://www.clinicaltrials.gov.

    Tibotec has the right to develop and commercialize telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand. Vertex will commercialize telaprevir in the U.S., Canada and Mexico.

    About HCV

    According to the World Health Organization, about 170 million people around the world are infected with chronic HCV and 3 to 4 million people are newly infected each year.(ii) Chronic infection with HCV can lead to cirrhosis and liver cancer, and is the most common cause of liver transplant in Europe .(ii), (iv)

    About Tibotec BVBA

    Tibotec BVBA is a global pharmaceutical and research development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.

    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 BVBA'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 31, 2006. 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 Tibotec BVBA or Johnson & Johnson. Tibotec BVBA does not undertake to update any forward-looking statements as a result of new information or future events or developments.

    Tibotec is a member of the Johnson & Johnson family of companies.

    (i) Phase 2 Study of Telaprevir Administered q8h or q12h with Peginterferon Alfa-2a or Alfa-2b and Ribavirin in Treatment-naïve Subjects with Genotype 1 Hepatitis C: Week 12 Interim Results. Xavier Forns, Patrick Marcellin, Tobias Goeser, Peter Ferenci, Frederik Nevens, Giampiero Carosi, Joost P Drenth, Koen De Backer Rolf van Heeswijk, Tony Vangeneugden, Gaston Picchio, Maria Beumont-Mauviel. AASLD, Oct. 31-Nov. 4, 2008.

    (ii) World Health Organization (WHO). Fact sheet No. 164. Revised October 2000. http://www.who.int/mediacentre/factsheets/fs164/en/.

    (iii) Using Pegylated Interferon and Ribavirin to Treat Patients with Chronic Hepatitis C. American Family Physician. 2005 Aug. Volume 72, Number 4. Raymond P. Ward, M.D., PH.D., Marcelo Kugelmas, M.D.

    (iv) Risk factors for hepatitis C recurrence after liver transplantation. J Viral Hepat. 2007 Nov;14 Suppl 1:89-96. Roche B, Samuel D. Assistance Publique-Hopitaux de Paris, Hôpital Paul Brousse, Centre Hépato-Biliaire; and INSERM, Unité 785; and Université Paris-Sud, UMR-S 785, Villejuif, France.

ots Originaltext: Tibotec Pharmaceuticals Ltd.
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