Medivir's partner Tibotec announced that final SVR24 results from phase IIb PILLAR study of TMC435 will be presented at the AASLD meeting today

Medivir's partner Tibotec announced that final SVR24 results from phase
IIb PILLAR study of TMC435 will be presented at the AASLD meeting today

Huddinge, Sweden - Medivir AB (OMX:MVIR), the research-based specialty
pharmaceutical company focused on the development of high-value
treatments for infectious diseases, notes that its development partner,
Tibotec Pharmaceuticals, has announced that safety and efficacy results
from the phase IIb PILLAR study of once-daily TMC435 in treatment-naïve
patients infected with hepatitis C will be presented as an oral
late-breaker at the AASLD meeting in San Francisco, USA today.

Tibotec released the following statement on 5th November 2011:

Tibotec to present final safety and efficacy results from phase 2b
PILLAR study of Once-daily TMC435 in late-breaker at AASLD

-- Data show high rates of virologic response and shortened treatment
duration; safety and tolerability comparable to placebo --

[San Francisco, CA. Saturday 5th November 2011] - Tibotec
Pharmaceuticals (Tibotec), one of the Janssen (Janssen) Pharmaceutical
Companies, today will present results of the final analysis of PILLAR, a
phase 2b study of the investigational hepatitis C virus (HCV) NS3/4A
protease inhibitor TMC435 in treatment-naïve patients with chronic
genotype 1 HCV, as part of a late-breaker oral presentation at the 62nd
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) in San Francisco, CA, USA.  

Results from the final PILLAR analysis showed that TMC435 administered
in combination with peginterferon α-2a and ribavirin (PR) resulted in
significantly higher sustained virologic response (SVR) rates compared
to placebo plus PR. In the two TMC435 treatment groups who received
TMC435 75mg, between 75 and 82 percent of patients achieved SVR24, and
in the two TMC435 treatment groups who received TMC435 150mg, between 81
and 86 percent of patients achieved SVR24. This is compared to 65
percent of patients in the placebo arm who achieved SVR24. In addition,
79 to 86 percent of patients in the TMC435 treatment arms had a
shortened treatment duration of 24 weeks, compared to a 48 weeks
treatment duration for patients who received placebo plus P/R. In TMC435
arms, 68 to 76 percent of patients achieved rapid virologic response
[RVR; HCV RNA<25 (undectectable)], of whom 88 to 95 percent achieved
SVR24. There were no significant differences for adverse events between
TMC435 treatment groups and placebo. TMC435 150mg administered once
daily (q.d.) is being investigated in phase 3 trials in treatment-naive
patients and in patients who experienced a viral relapse after being
treated with interferon-based therapy. TMC435 is being developed by
Tibotec Pharmaceuticals. Medivir AB has commercialization rights for
TMC435 for the Nordic countries, Janssen has commercialization rights
for TMC435 in the rest of the world.

The PILLAR study [Protease Inhibitor TMC435 trial assessing the optimaL
dose and duration as once daiLy Anti-viral Regimen] (TMC435-C205;
NCT00882908) was a five-arm, global phase 2b randomized, double-blind,
placebo controlled study in 386 treatment-naive patients. TMC435 was
administered in doses of 75mg or 150mg q.d. for either 12 weeks or 24
weeks in combination with 24 or 48 weeks of peg-interferon and ribavirin
(PR). Patients in the placebo arm receive 24 weeks of placebo plus
peg-interferon and ribavirin followed by 24 additional weeks of
peg-interferon and ribavirin treatment. The primary endpoint of the
study was sustained virologic response at Week-72 (SVR week 72). The
PILLAR study was conducted in 13 countries in Europe, North America, and
Australasia.
Patients receiving TMC435 were allowed to stop all treatment at week 24
if they met both response-guided criteria: a) detectable or undetectable
HCV RNA levels (< 25 IU/mL) at week 4 and b) undetectable HCV RNA at
weeks 12, 16 and 20. Patients who did not meet the above response-guided
criteria continued with peg-interferon and ribavirin until Week-48.

“HCV is a devastating problem worldwide and remains a leading cause of
cirrhosis, liver cancer, and liver transplantation,” said Dr. Michael W.
Fried M.D., lead clinical investigator and Professor of Medicine,
Director, UNC Liver Center, University of North Carolina at Chapel Hill.
“We are extremely encouraged by the success of once-daily TMC435 in
achieving significantly higher SVR compared to control group and look
forward to furthering its development in recently launched phase 3
trials.”

The goal of HCV treatment is to achieve SVR24, which means the virus is
undetectable in patients' blood six months after they have finished
treatment. Patients who achieve SVR are considered cured.

The most common adverse events (AEs) in the PILLAR study were headache
and fatigue, 46 percent and 42 percent in the TMC435 groups and 51
percent and 47 percent in the placebo group respectively. There were no
clinically significant differences in frequency of rash, anemia or
gastrointestinal events between the TMC435 groups and placebo. Most AEs
were mild to moderate in severity. AEs leading to treatment
discontinuation of TMC435/placebo were reported in 7.1 percent of
patients in TMC435 arms and 7.8 percent in placebo arm.

“Tibotec is pleased to present the final results of the phase 2b PILLAR
study at AASLD. The continued development of TMC435, which is currently
being investigated in registrational phase 3 studies, reinforces our
strong commitment to the development of new therapies that may reduce
treatment duration and improve the lives of those impacted by HCV,” said
Maria Beumont M.D., Global Medical Leader TMC435 at Tibotec.

In conjunction with the final sustained virologic response (SVR) results
from PILLAR, Tibotec is presenting virology analysis data from PILLAR
and two sets of early study results on the effects of co-administering
TMC435 and methadone and its interaction with the antidepressant
escitalopram, to be featured in 3 posters at AASLD:

  · “TMC435 in combination with peginterferon alpha-2a/ribavirin in
treatment-naïve patients infected with HCV genotype 1: virology analysis
of the PILLAR study.” O. Lenz.
  · “The pharmacokinetic interaction between the investigational NS3-4A
HCV protease inhibitor TMC435 and methadone.” M. Beumont-Mauviel.
  · “The pharmacokinetic interaction between the investigational HCV
NS3/4A protease inhibitor TMC435 and escitalopram.” M. Beumont-Mauviel.

Tibotec is currently conducting two global, phase 3 registrational
trials to examine TMC435 in treatment-naïve adults with chronic genotype
1 hepatitis C virus (HCV). A third global phase 3 trial is being
conducted in genotype 1 HCV patients who have experienced a viral
relapse after prior interferon-based treatment. All three studies are
fully randomized.

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)                               Mobile:
+46 708 537 292 
Rein Piir, EVP Corporate Affairs & IR
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

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/).