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


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

Huddinge, Sweden - MedivirAB (OMX: MVIR) is an emerging researchbased
specialty pharmaceutical company focused on infectious diseases.

Medivir 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-naïve
patients
  · TMC435-C216 or QUEST-2 includes approximately 375 treatment-naïve
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.”

For more information about Medivir, please contact:

Medivir (www.medivir.com (http://www.medivir.com/)):
Rein Piir, CFO & VP Investor Relations                                  
                    Mobile: +46 708 537 292
M:Communications:Peter Laing / Amber Bielecka
Medivir@mcomgroup.com (Medivir@mcomgroup.com)  +44(0)20 7920 2330
USA: Roland Tomforde                                                    
                     +1 212-232-2356

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 PegIFN/RBV and in
combination with Direct-acting Antiviral (DAA) agents without
peginterferon and with or without ribavirin (RBV).

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-naïve and in
G1 patients that failed previous IFN-based treatment. More safety and
efficacy data from the phase 2b trials will be presented at scientific
meetings later in 2011.

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

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 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.

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 have recently been sold to Meda AB.
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/)

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