More Than 80 Percent of HCV Genotype 1 Treatment-Naive Patients Achieved Sustained Virologic Response With Twice-Daily Telaprevir-Based Regimen

More Than 80 Percent of HCV Genotype 1 Treatment-Naive Patients Achieved Sustained Virologic Response With Twice-Daily Telaprevir-Based Regimen

http://www.jnj.com

Phase II telaprevir data from Tibotec featured in oral presentation at AASLD
Cork, Ireland (October 31, 2009) –Tibotec announced today results of a new study (VX950-C208), which showed that sustained virologic response (SVR) was achieved in more than 80 percent of treatment-naïve patients with chronic genotype 1 hepatitis C virus (HCV) who took telaprevir, administered either every 8 hours or every 12 hours, in combination with standard of care. Telaprevir, an investigational STAT-C (Specifically Targeted Antiviral Therapy for hepatitis C), is being co-developed by Tibotec in collaboration with Vertex Pharmaceuticals.

The study was presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting).In the phase II study, which enrolled 161 treatment-naïve genotype 1 patients, rates of SVR (defined as undetectable HCV RNA at 24 weeks after completion of treatment) ranged from 81 to 85 percent in patients treated with the every 8 hour telaprevir-based regimen, and 82 to 83 percent in patients treated with the every twelve hour regimen. Adverse events (AEs) were similar to those observed in other trials with telaprevir and were mainly haematologic (anaemia) and cutaneous (rash and pruritus) in nature.For the vast majority of patients, these high SVR rates were obtained with only 24 weeks of total treatment (half the duration of current standard of care).

Total duration of treatment was decided using a criteria based on treatment response. Subjects who achieved undetectable HCV RNA at week 4 (rapid virologic response or RVR) and maintained this through week 20, were allowed to stop all treatment at week 24.

Only 18% of subjects were required to continue standard treatment up to week 48.Approximately 180 million people worldwide are infected with HCV,1 the most common cause of liver transplant in Europe.2 People with HCV genotype 1 currently face treatment limitations, including a standard of care that cures just 40 to 50 percent of patients.3 Without effective treatment, HCV can lead to serious and fatal diseases of the liver, including liver cancer4. “The data presented today show that a significant number of treatment-naïve genotype 1 HCV patients achieved sustained virologic response with telaprevir, in combination with standard of care,” said professor Patrick Marcellin from Hôpital Beaujon in Clichy, France. “Telaprevir, which directly targets the virus by aiming to block its replication, could allow shortening treatment duration and increasing cure rates in people with HCV, [compared to standard of care] offering a new approach to treating HCV.”

About Telaprevir C208 study in Treatment-Naïve PatientsThe phase IIa, open-label, randomised study evaluated telaprevir administered every eight hours or every 12 hours in combination with standard of care Peg-IFN alfa-2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve patients with chronic genotype 1 HCV infection.

The objective of the trial was to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg every eight hours or 1125 mg every 12 hours in combination with Pegasys and Copegus or PegIntron and Rebetol. A total of 161 subjects were randomised to the following groups:

A: Telaprevir 750 mg q8h with Pegasys/Copegus (Tq8h/Peg2-a) (n=40)B: Telaprevir 750 mg q8h with PegIntron/Rebetol (Tq8h/Peg2-b) (n=42)C: Telaprevir 1125 mg q12h with

Pegasys/Copegus (Tq12h/Peg2-a) (n=40)D: Telaprevir 1125 mg q12h with PegIntron/Rebetol (Tq12h/Peg2-b) (n=39)

All subjects received 12 weeks of telaprevir treatment in combination with standard therapy. At the end of Week 12, telaprevir dosing was completed and subjects continued on standard therapy only. Most subjects achieved Rapid Virological Response (RVR) (undetectable at week

4) and remained undetectable until week 20 and were allowed to stop all treatment at week 24.

Only 18% of subjects were required to continue standard treatment up to week 48.Following are the efficacy findings, as measured by sustained viral response rates (SVRs):
85 percent of patients taking telaprevir 750 mg q8h with Tq8h/Peg2-a achieved SVR
81 percent of patients taking telaprevir 750 mg q8h with Tq8h/Peg2-b achieved SVR
82.5 percent of patients taking telaprevir 1125 mg q12h with Tq12h/Peg2-a achieved SVR
82.1 percent of patients taking telaprevir 1125 mg q12h with Tq12h/Peg2-b achieved SVR

The pharmacokinetic/pharmacodynamic analysis showed that total exposure to telaprevir (measured as AUC24h) was similar across all groups.AEs were similar to those observed in other trials with Telaprevir. Serious AEs leading to permanent treatment discontinuation of all drugs were mainly related to rash (3%, 4/161) and anemia (2%, 3/161).

“For too long, people with HCV have faced treatment limitations, necessitating a paradigm shift in HCV therapy,” said Roger Pomerantz, MD, President of Tibotec Research and Development. “Tibotec is proud to apply its expertise in virology to discover, develop and make available new therapies that target HCV in a different way.”

About TelaprevirThere are currently two fully enrolled, pivotal phase 3 clinical trials examining telaprevir in genotype 1 HCV-infected adults – REALIZE in treatment-experienced patients and ADVANCE in treatment-naïve patients. REALIZE is the only ongoing phase 3 study comparing the efficacy of a regimen containing a STAT-C to current standard of care in null responders, while ADVANCE is evaluating the potential for a 24-week duration of therapy in treatment-naïve HCV genotype 1 patients.

A third phase 3 study, ILLUMINATE, also fully-enrolled, will provide additional data on telaprevir in treatment-naïve patients. Tibotec has the right to develop and commercialise telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand; Vertex will commercialise telaprevir in the U.S., Canada, and Mexico and has a collaboration with Mitsubishi for commercialization in the Far East. About Tibotec BVBATibotec 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.