Medivir completes enrollment of three TMC435 phase 3 trials on CHC genotype-1 infection

MedivirAB (OMX:MVIR) is an emerging researchbased specialty pharmaceutical company focused on infectious diseases.

Medivir today announced that its investigational protease inhibitor TMC435, developed by Tibotec Pharmaceuticals, has successfully completed enrollment of three ongoing global phase 3 trials and further reports that all patients are now on TMC435 or active control treatment. The trials are QUEST 1 and QUEST 2, in treatment naive patients, and PROMISE in the treatment experienced relapser patient population. In all three trials, the duration of total treatment is response guided and patients in the TMC435 arms are eligible to stop all treatment at week 24 if predefined response-guided criteria are met.

Medivir recently announced that TMC435 had received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of chronic HCV infection.

In parallel to these trials, phase 3 studies for TMC435 in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, have also completed enrollment.

Global Phase 3 Program in brief:

· TMC435-C208 or QUEST-1 includes approximately 375 treatment-naïve patients

· TMC435-C216 or QUEST-2 includes approximately 375 treatment-naïve patients

· TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment

Bertil Samuelsson, Chief Scientific Advisor at Medivir, comments - "We are extremely excited to have completed the enrollment and patient dosing in three large global phase 3 trials. It is a monumental milestone step for Medivir as a company and for TMC435 progress towards market registration. The completed enrollment of phase 3 studies for TMC435 in Japan represents another key project milestone achievement."