Medivir Notes that Partner Tibotec Announced Week 24 Interim Results from Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at AASLD

Medivir Notes that Partner Tibotec Announced Week 24 Interim Results
from Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at
AASLD

Huddinge, Sweden - Medivir AB (OMX:MVIR), the research-based speciality
pharmaceutical company focused on the development of high-value
treatments for infectious diseases, notes that its development partner,
Tibotec Pharmaceuticals, has announced the results of a Week-24 planned
interim analysis of the Phase 2 response-guided PILLAR study for TMC435,
Medivir's key pipeline asset, a hepatitis C protease inhibitor dosed
once-daily.  The study was conducted in treatment-naïve patients with
chronic genotype 1 Hepatitis C virus (HCV) and is part of a late-breaker
oral presentation at the 61st Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD) in Boston, MA., USA. 

Highlights of the data:

  · 79% to 86% of patients were able to stop all therapy at week-24
  · No relevant differences for adverse events between TMC435 treatment
groups and placebo  

Commenting on the announcement by Medivir's development partner,
Tibotec, Ron Long, Chief Executive of Medivir, said: “We are very
pleased to have such exciting TMC435 data presented by our partner,
Tibotec, at the AASLD. The data announced shows the significant impact
that TMC435 could have on the way we treat hepatitis C.”  

Please note that Medivir will be hosting meetings for Investors,
Analysts and the Media at the AASLD (see end of press release). 

Tibotec released the following statement on the results on Saturday 30th
October:  

Week 24 interim results from phase 2b PILLAR study to be presented as
late-breaker at AASLD

-- Data show high antiviral activity, safety and tolerability comparable
to placebo --  

Boston, MA. Saturday 30th October 2010 - Tibotec Pharmaceuticals
(Tibotec) today will present the results of a Week-24 planned interim
analysis of the phase 2 response-guided PILLAR study in treatment-naïve
patients with chronic genotype 1 hepatitis C virus (HCV) as part of a
late-breaker oral presentation at the 61st Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in Boston,
MA., USA.   

The results showed that in the four TMC435 treatment groups between 79
and 86 percent of patients were able to stop all therapy at Week-24,
according to the response criteria defined in the study protocol. There
were no relevant differences for adverse events between TMC435 treatment
groups and placebo. TMC435, a hepatitis C protease inhibitor, dosed once
daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and
Medivir.  

The PILLAR study [Protease Inhibitor TMC435 trial assessing the optimaL
dose and duration as once daiLy Anti-viral Regimen] (TMC435-C205;
NCT00882908) is an ongoing, 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 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 is sustained virologic response at Week-72 (SVR24). The PILLAR
study is being conducted in 13 countries in Europe, North America, and
Australasia. 

Patients receiving TMC435 were allowed to stop all treatment at week 24
when a) HCV RNA levels < 25 IU/mL at week 4  and b) HCV RNA < 25 IU/mL
levels 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. TMC435 demonstrated potent antiviral activity, at week 4
(rapid virologic response (RVR)) and at week 12 (complete early
virologic response (cEVR)) HCV RNA was undetectable (<25IU/ml) for the
majority of patients. The viral breakthrough rate was 4.9 percent in the
TMC435 treatment groups.  

“Chronic infection with HCV is a leading cause of cirrhosis, liver
cancer, and liver transplantation worldwide” said Dr Michael W. Fried
M.D., lead clinical investigator and Professor of Medicine, Director of
Hepatology, University of North Carolina at Chapel Hill. “We are
extremely encouraged by these data for TMC435."  

The goal of HCV treatment is to achieve SVR24, which means the virus
remains undetectable in patients' blood six months after they have
finished treatment. Patients who achieve SVR are considered cured. The
current standard of care for HCV, pegylated interferon combined with
ribavirin, may cause debilitating side effects[i] and cures only about
half of patients starting therapy for the first time.[1]

The most common adverse events 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 were reported in 7.1
percent of patients in TMC435 arms and 7.8 percent in placebo arm.  

In laboratory parameters, significant decreases in transaminases (ALT
and AST) were observed in all treatment groups. Small and transient
bilirubin elevations (direct and indirect) were seen in the TMC435 150mg
dose groups.

“With a strong heritage in virology, Tibotec is committed to improving
the lives of those impacted by HCV through the development of innovative
new treatment regimens,” said Greg Fanning PhD, head of hepatitis C
research and development at Tibotec. “TMC435 is an important component
of our growing HCV pipeline and we are encouraged by the results of the
interim analysis presented at the AASLD meeting.” 

TMC435 is also being studied in HCV genotype-1 treatment-experienced
patients who have failed treatment with peg-interferon and ribavirin.
The ASPIRE study (Antiviral STAT-C Protease Inhibitor Regimen in
Experienced patients; TMC435-C206; NCT00980330) is an ongoing global
phase 2b randomized, double-blind, placebo controlled study in 463
patients.  

In addition to the late-breaker oral presentation described above, data
on TMC435 has been presented in 4 posters at AASLD:

278. “In vitro studies investigating the mechanism of interaction
between TMC435 and hepatic transporters.” M.T. Huisman

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.” O. Lenz

895. “A Phase IIa, open-label study to assess the antiviral activity of
TMC435 monotherapy in patients infected with HCV genotypes 2-6.” C.
Moreno

1873. “Pharmacokinetic-pharmacodynamic analyses of TMC435 in patients
infected with Hepatitis C Virus (HCV) genotypes 2 to 6.” V. Sekar

About HCV
HCV is a blood-borne infectious disease that affects the liver.1 With an
estimated 170 million people infected worldwide1 and three to four
million people newly infected each year,2 HCV puts a significant burden
on patients and society. Chronic infection with HCV can lead to liver
cancer and other serious and fatal liver diseases, and is the most
common cause of liver transplant worldwide.3 Discovering and developing
new treatments is very important to improving the standard of care for
the millions of people living with this disease. 

About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals is a global pharmaceutical and research
development company. The Company's main research and development
facilities are in Beerse, Belgium with offices in Titusville, NJ and
Cork, Ireland. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for
diseases of high unmet medical need. Tibotec Pharmaceuticals is a
subsidiary of Johnson & Johnson. 

[1]World Health Organization (2002). Hepatitis C. Retrieved October 26,
2010 from http://www.who.int/csr/disease/hepatitis/Hepc.pdf

2 Hepatitis C: Global Prevalence. Weekly Epidemiological Record. 1997;72
: 341-8. Retrieved October 26, 2010
from http://www.who.int/docstore/wer/pdf/1997/wer7246.pdf (http://www.wh
o.int/docstore/wer/pdf/1997/wer7246.pdf). 

3 Roche B, Samuel D., Villejuif, France. Risk factors for hepatitis C
recurrence after liver transplantation.  J Viral Hepat. 2007 Nov;14.
Suppl 1:89-96. 

- Ends -

Medivir Activities for Investors, Analysts and the Media at the AASLD: 

Medivir will provide an update on the development of TMC435 and the data
presented at AASLD on Tuesday 2 November, 2010.  The meetings will be
hosted by Rein Piir (CFO/IR), Bertil Samuelsson, (CSO) and Åsa
Rosenquist, (Director). 

Medivir Conference Call For European Analysts and Investors:

Tuesday, November 2, 2010 at 6.30am EDT / 10.30am GMT / 11.30am CET
Please register for the conference call online at:
http://invite.taylor-rafferty.com/_Medivir/ConferenceCall (http://invite
.taylor-rafferty.com/_Medivir/ConferenceCall)
You will receive the dial-in and replay numbers for the conference call
following your online registration. 

Breakfast Meeting for US based Analysts, Investors and Media at AASLD: 

Tuesday November 2, 2010 at 7:00am - 8.30am EDT (breakfast will be
served between 7:00am - 7.30am EDT)

Venue: Colonnade Hotel, Braemore & Kenmore Room, 120 Huntington Avenue,
Boston
Please confirm your participation by registering on-line:
http (http://invite.taylor-rafferty.com/_Medivir/Breakfast/default.htm):
//invite.taylor-rafferty.com/_Medivir/Breakfast/default.htm (http://invi
te.taylor-rafferty.com/_Medivir/Breakfast/default.htm) 

For enquiries about the above briefings, please contact: Lindsey Neville
at M:Communications on +44 (0)20 7920 2333 or Jason Marshall on +1 212
889 4350 or email Neville@mcomgroup.com (Neville@mcomgroup.com) 

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:CommunicationsEurope: Mary-Jane Elliott / Emma Thompson / Amber
Bielecka   Medivir@mcomgroup.com (Medivir@mcomgroup.com)
                                                                        
    +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 genotype 1 (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 Standard of
Care treatment consisting of pegylated interferon and ribavirin upon
agreement with the study doctor.