TMC435 for Hepatitis C Phase 3 Studies Fully Enrolled, Company Says

Medivir announced last week that Phase 3 clinical trials of its investigational hepatitis C virus (HCV) protease inhibitor, TMC435 (initially developed by Tibotec/Janssen), are have completed enrollment and participants have begun receiving randomized treatment.

Below is an edited excerpt from a Medivir press release describing the studies and their progress.

Completed Enrollment of Three Global Phase 3 Trials for TMC435 in Chronic Hepatitis C Genotype-1 Infected Patients

August 31, 2011 -- Huddinge, Sweden -- Medivir AB (OMX: MVIR), an emerging research-based specialty pharmaceutical company focused on infectious diseases, 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-naive patients
• TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive 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."

About TMC435

TMC435, an investigational CHC protease inhibitor currently in Phase 3 clinical development, is a highly potent, selective and safe once-daily (q.d.) drug jointly developed by Tibotec Pharmaceuticals to treat chronic hepatitis C virus infections.

TMC435 is being developed both in combination with [pegylated interferon/ribavirin] and in combination with Direct-Aacting Antiviral (DAA) agents without peginterferon and with or without ribavirin.

In June 2011 the combination study of TMC435 with TMC647055, a non-nucleoside NS5B polymerase inhibitor being developed by Tibotec Pharmaceuticals, was initiated and in July 2011 Medivir confirmed the intention to start a proof-of-concept oral, interferon-free Phase 2 trial, investigating the combination of TMC435 and Pharmasset's PSI-7977, a once daily nucleotide NS5B polymerase inhibitor. Phase 3 programs for TMC435 are also ongoing in Japan.

In parallel with the recent start of the global Phase 3 studies, TMC435 is currently in a follow up phase in three Phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous [interferon]-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is TMC435, a novel protease inhibitor is in phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals. In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialization of TMC435 in the Nordic markets, once approved.

For more information about Medivir, see www.medivir.com.

9/6/11

Source

Medivir. Completed Enrollment of Three Global Phase 3 Trials for TMC435 in Chronic Hepatitis C Genotype-1 Infected Patients. Press release. August 31, 2011.