Medivir Announces Final Results from TMC435 Phase IIb ASPIRE (C206) Study

Medivir Announces Final Results from TMC435 Phase IIb ASPIRE (C206)
Study

TMC435-Based Therapy Significantly Improved Viral Cure Rates in Patients
Who Failed Prior Treatment for Hepatitis C

- ASPIRE: All TMC435 subgroups achieved substantially higher viral cure
rates (SVR24) compared with control group (pegylated interferon and
ribavirin alone): 85% vs. 37% in prior relapsers, 75% vs. 9% in prior
partial responders and 51% vs. 19% in prior null responders -

- Once daily TMC435 was generally safe and well tolerated at all doses
and treatment durations -

Medivir AB (OMX: MVIR), a research-based speciality pharmaceutical
company focused on infectious diseases, today announces final results
from the ASPIRE study. This phase IIb study evaluated TMC435 once daily
in addition to pegylated interferon (PegIFN) and ribavirin (RBV) in
patients with genotype-1 chronic hepatitis C whose prior treatment with
PegIFN and RBV was unsuccessful either because they relapsed, had a
partial response or had a null response.

Data from the ASPIRE study showed that patients in each of these
subgroups who were treated with TMC435-based combination therapy
achieved superior rates of sustained virologic response (viral cure)
compared with those retreated with PegIFN and RBV alone.

Charlotte Edenius, Executive VP Research and Development, of Medivir
commented, "We are extremely pleased with the final results from the
ASPIRE study showing high viral cure rates and a favourable safety and
tolerability profile in these difficult to treat genotype-1 hepatitis C
patients whose prior treatment was unsuccessful. These results may
provide new optimism for people who have failed on previous therapy,
including those with advanced liver disease. We are highly committed to
the broad and rapid development of TMC435 and global pivotal phase III
clinical trials are currently well underway”

ASPIRE (C206) - Design
TMC435, a potent, once-daily, oral hepatitis C virus protease inhibitor,
is being developed by Tibotec jointly with Medivir. The randomized,
placebo-controlled, double-blind ASPIRE study evaluates the effect of
TMC435 in combination with pegylated-interferon and ribavirin in 462
patients infected with genotype-1 hepatitis C virus who have failed
prior treatment with PegIFN/RBV. The primary endpoint was proportion of
patients with undetectable HCV RNA 24 weeks after the planned end of
treatment (SVR24).

The study includes patients who have relapsed, achieved partial
response, or achieved no response (null responders) to PegIFN/RBV
treatment. 62 percent (287/462) of patients had advanced liver disease,
periportal or septal fibrosis or cirrhosis (scarring of the liver) upon
study entry (Metavir score F2-F4).

Patients were equally randomized to one of seven different treatment
arms, six TMC435 treatment arms and one placebo arm. TMC435 was
administered once daily at a dose of either 100 mg or 150 mg given for
either 12, 24, or 48 weeks in combination with 48 weeks of PegIFN/RBV.
The results are based on the intent-to-treat (ITT), population which
included all randomized patients who took at least one dose of the study
medication.

Results - Efficacy
In this final analysis, all subgroups of treatment-experienced patients
who failed previous PegIFN and RBV treatment, achieved substantially
higher virologic response rates following treatment with
TMC435-containing regimen at all doses and durations, compared with
PegIFN and RBV alone.

Regardless of treatment duration all TMC435 treatment arms showed
significantly improved effect on SVR24 versus PegIFN/RBV alone.

Sustained Virologic Response (SVR24) Rates in TMC435 Dose Groups (150 mg
q.d.) vs Placebo
% (n/N)             TMC435        TMC435        TMC435        All TMC435
   Placebo
                    12PR48        24PR48        48PR48        PR48      
   PR48
                    N=66          N=68          N=65          N=199     
   N=66
Relapsers           76.9 (20/26)  88.9 (24/27)  88.5 (23/26)  84.8
(67/79)  37.0 (10/27)
SVR24
Partial Responders  65.2 (15/23)  75.0 (18/24)  86.4 (19/22)  75.3
(52/69)  8.7 (2/23)
SVR24
Null Responders     52.9 (9/17)   41.2 (7/17)   58.8 (10/17)  51.0
(26/51)  18.8 (3/16)
SVR24

q.d.: once daily; PR: pegIFNalpha-2A and ribavirin; EoT: End of
Treatment,
SVR24: patients with undetectable HCV RNA (<25 IU/mL Undetectable) 24
weeks after planned EoT. All TMC435 groups: p<0.001 vs placebo.
Prior Relapser: undetectable HCV RNA at EoT and detectable within 24
weeks of follow-up
Prior Partial Responders: more than 2 log reduction in HCV RNA at W12
but not achieving undetectable at EoT
Prior Null Responders: less than 2 log reduction in HCV RNA at W12

Results - Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of
adverse events (AEs) was similar across treatment groups. Most of the
AEs were grade 1 or 2 in severity. Serious AEs (SAEs) were reported in
6.1% subjects in the placebo and in 7.8% of the patients treated with
TMC435. AEs leading to treatment discontinuation were reported in 4.5%
of the placebo patients and in 7.8% of the TMC435 treated patients.
Patients in the TMC435 ASPIRE treatment groups had overall longer
treatment duration than patients in the placebo group due to a higher
frequency of early discontinuation in the placebo group due to treatment
failures (i.e. reaching viral stopping rules). The most common AEs
during the treatment period were headache, fatigue, pruritus and
influenza-like illness. Incidence was similar across treatment groups
and the level of AEs and frequency were consistent with the prior phase
IIb (PILLAR) study in treatment-naïve hepatitis C patients of TMC435.

In the safety analyses, special attention was given to the following AEs
of interest: hepatobiliary AEs, pruritus, rash and anemia. Most AEs of
interest were grade 1 or 2 in severity and infrequently led to treatment
discontinuation. For each category of AEs of interest the incidence was
similar for the TMC435 treatment arms and control arm.

Mild and reversible increases in bilirubin (total, direct and indirect)
were observed in TMC435 dose groups with no differences between 100 mg
and 150 mg. There were no meaningful differences between treatment
groups for any of the other laboratory parameters. There were no
clinically significant findings on vital signs. Mean alanine
aminotransferase (ALT) levels decreased in all treatment groups.

DRAGON (C215) - Update on recently published results
The final data from the phase II Dragon study in Japan was recently
published at the Japan Digestive Disease Week meeting, 20-23 October
2011 in Fukuoka, Japan. The DRAGON study is a phase II randomized,
open-label, response-guided study to evaluate the efficacy, safety, and
pharmacokinetics of TMC435 plus PegIFN/RBV in 92 Japanese
treatment-naïve patients infected with HCV genotype-1.

Addition of once daily TMC435 (100 mg) to PegIFN/RBV increased the viral
cure rate (SVR24) from 46% in the PegIFN/RBV only group to 82% (32/39)
in the TMC435 100mg groups. In these groups, 87% of patients were
eligible to complete all treatment at Week 24 if preset criteria on
virologic response were met. TMC435 was generally safe and well
tolerated with no apparent difference in the safety profile between
TMC435 treatment groups and the control group (PegIFN/RBV only).

About TMC435
TMC435 is a highly potent and selective once-daily (q.d.)
investigational drug that is being jointly developed by Tibotec
Pharmaceuticals and Medivir to treat chronic hepatitis C virus
infections.

TMC435 has 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. TMC435 is
currently being developed in three global phase III studies, QUEST-1 and
QUEST-2 in treatment-naïve patients and PROMISE in patients who have
relapsed after prior interferon-based treatment. In parallel with these
trials, phase III studies for TMC435 in Japan, in both treatment naive
and treatment experienced hepatitis C genotype-1 infected patients, are
ongoing.

For additional information from these studies, please see
www.medivir.com and
www.clinicaltrials.gov (http://www.clinicaltrials.gov/)

For more information about Medivir, please contact:
Medivir (www.medivir.se) Rein Piir, EVP Corporate Affairs & IR  Mobile:
+46 708 537 292 
M:Communications                                               
Medivir@mcomgroup.com (Medivir@mcomgroup.com)
Europe: Peter Laing, Amber Bielecka, Claire Dickinson           +44(0)20
7920 2330
USA: Roland Tomforde                                            +1 212
232 2356

Conference call for analysts and investors:
There will be a conference call today, 2 November 2011, for investors
and analysts at 11.00 (EDT) / 15.00 (GMT) / 16.00 (CET) to discuss the
data. To dial-in to the conference call please use the following
numbers:

Participant telephone numbers:                                        
Sweden                                                      +46
(0)200 884 518
Europe                                                       +44 (0)1452
569 335
USA                                                             +1
866 655 1591
Please quote participant code                        23849230

Soundbyte replay access numbers:             
Sweden                                                      +46 (0)200
899 157
Europe                                                       +44 (0)1452
55 00 00
USA                                                             +1
866 247 4222
Replay access code:                                            23849230#

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.

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 that is in phase III 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.

Medivir's first product, the unique cold sore product Xerese®/Xerclear®,
was launched on the US market in February 2011. Xerese®/Xerclear®, which
has been approved in both the US and Europe is partnered with
GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in
North America, Canada and Mexico were sold to Meda AB in June 2011.
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.com (http://www.medivir.com/).