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

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 ~

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 - 2 November 2010 in Boston, USA. The abstracts
have been published today and can be accessed on the AASLD website
http://www.aasld.org (http://www.aasld.org/). In accordance with the
AASLD embargo policy, information about the studies and 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 α-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
α-2a and ribavirin in treatment-naïve 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.” 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 2-6.” 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).

For more information about Medivir, please contact:

Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations  Office:
+46 8 546 831 23
                                                                 Mobile:
+46 708 537 292 
M:Communications                                                
Medivir@mcomgroup.com (Medivir@mcomgroup.com)
Europe: Mary-Jane Elliott/Emma Thompson                         
+44(0)20 7920 2330
USA: Jason Marshall                                              +1 212
897 5497

About Medivir
Medivir is a 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. Medivir has a strong R&D portfolio and has
recently launched its first product Xerese™/Xerclear™. Medivir's key
pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical
development for Hepatitis C and is partnered with Tibotec
Pharmaceuticals.   

Xerese™/Xerclear™ is an innovative treatment for cold sores, which has
been approved in both the US and Europe. It is partnered with GSK to be
sold OTC in Europe and Russia and with Meda in North America. Medivir
has retained the Rx rights for Xerclear™ in Sweden and Finland. 

For more information about Medivir, please visit the Company's website:
www.medivir.se (http://www.medivir.se/)

About TMC435 clinical trial programs
TMC435 is a once daily protease inhibitor jointly developed by Medivir
and Tibotec Pharmaceuticals to treat hepatitis C virus
infections. TMC435 is currently being studied in three phase 2b clinical
trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naïve
and in G1 patients that failed previous IFN-based treatment. TMC435 is
planned to enter phase 3 studies early 2011.

PILLAR Study (TMC435-C205)
TMC435-C205 is an ongoing randomized double-blind global phase 2b study
in 386 genotype-1 treatment-naïve patients. It evaluates once daily
treatment of TMC435 with different doses and durations given in addition
to standard of care treatment, consisting of ribavirin and
pegIFNalpha-2A.

ASPIRE Study (TMC435-C206)
TMC435-C206 is an ongoing randomized double-blind global phase 2b study
in 463 genotype-1 treatment-experienced patients. It evaluates once
daily treatment of TMC435 in with different doses of given in addition
to standard of care treatment, consisting of ribavirin and
pegIFNalpha-2A.

TMC435-C215
TMC435-C215 is an ongoing Japanese phase 2b study in 92 genotype-1
treatment-naïve patients. It evaluates once daily treatment of TMC435
with different doses and durations given in addition to standard of care
treatment, consisting of ribavirin and pegIFNalpha-2A. 
Opera-2 (TMC435-C202)
TMC435-C202 is a completed phase 2a study in treatment-naïve genotype 2
to 6 HCV patients. It is a once daily treatment of TMC435 during seven
days, at 200 mg. Subsequently, patients could continue with SoC
treatment consisting of pegylated interferon and ribavirin upon
agreement with the study doctor.

 About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a
leading cause of chronic liver disease and liver transplants. The WHO
estimates that nearly 180 million people worldwide, or approximately 3%
of the world's population, are infected with hepatitis C virus (HCV).
The CDC has reported that almost three million people in the United
States are chronically infected with HCV.