Medivir Announces Publication of Five TMC435 Abstracts for Presentation at the 61st AASLD Meeting

Cision (English) - Oct. 01, 2010

Medivir Announces Publication of Five TMC435 Abstracts for Presentation at the 61st AASLD Meeting

 Including a Late-breaking Oral Presentation of 24-Week interim data of the TMC435 phase 2b PILLAR study Ë

Medivir AB (OMX: MVIR), a research-based speciality pharmaceutical company focused on infectious diseases, today announces that five abstracts related to its hepatitis C drug in development, TMC435, have been accepted for presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from 29 October â?? 2 November 2010 in Boston, USA. The abstracts have been published today and can be accessed on the AASLD website http://www.aasld.org  The accepted titles only are provided below. TMC435, a hepatitis C protease inhibitor, is being jointly developed by Medivir and Tibotec Pharmaceuticals.

At the meeting, in a late-breaking oral presentation, the results from a pre-planned Week 24 interim analysis of the ongoing Phase 2b PILLAR study of TMC435 will be presented. In this study, patients were dosed once-daily with TMC435 in combination with peg interferon a-2a (PegIFN) and ribavirin (RBV) in treatment naive patients infected with HCV genotype 1 (G1). 24-Week interim analysis data will be reported including rapid virologic response (RVR), complete early viral response (cEVR), sustained viral response rates after four weeks (SVR4), and twelve weeks (SVR12) respectively. Secondary endpoints, including the assessment of antiviral activity, viral breakthrough, safety and tolerability, and response rates in IL-28B genotypes, will also be presented.

Additionally, there will be four poster presentations shown at the meeting. Two poster presentations will describe the antiviral activity, safety, tolerability, and pharmacokinetics from a phase 2a open-label, proof-of-concept study of TMC435 in patients infected with HCV genotype 2 to 6.

The other two poster presentations will describe the virologic analysis of G1 infected patients following treatment with once-daily TMC435 in the phase 2a (OPERA-1) study and in vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters.

Accepted titles for Abstracts to be presented at the 2010 AASLD meeting are as follows:

Late Breaker Oral Presentation for presentation at Monday 1 Nov. 17:45 (EST): LB-5. Efficacy and safety of TMC435 in combination with peginterferon a-2a and ribavirin in treatment-naive genotype-1 HCV patients: 24-week interim results from the PILLAR study.

Poster Presentations: 278. In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters. To be presented: Saturday 30 Oct, 14:00 (EST). 812. Virologic analysis of genotype-1-infected patients treated with once-daily TMC435 during the Optimal Protease inhibitor Enhancement of Response to Therapy (OPERA)-1 study.â?? To be presented: Sunday 31 Oct, 08:00 (EST). 895. A Phase 2a, open-label study to assess the antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2a.  To be presented: Sunday 31 Oct, 08:00 (EST). 1873. Pharmacokinetic-pharmacodynamic analyses of TMC435 in patients infected with Hepatitis C Virus (HCV) genotypes 2 to 6. To be presented: Tuesday 2 Nov, 07:00 (EST).