Medivir: First interim results from a phase IIa study evaluating an all-oral regimen of Simeprevir and Sofosbuvir in prior null

  Medivir: First interim results from a phase IIa study evaluating an all-oral
  regimen of Simeprevir and Sofosbuvir in prior null responder Hepatitis C
  patients

Business Wire

STOCKHOLM -- March 4, 2013

Regulatory News:

Medivir AB (STO:MVIR-B) today announced first interim results from the cohort
1 of a Phase IIa study of the investigational protease inhibitor simeprevir
(TMC435) administered once daily with Gilead’s investigational nucleotide
inhibitor sofosbuvir (GS-7977) with and without ribavirin for 12 and 24 weeks
in genotype 1 prior null-responder hepatitis C patients with mild to moderate
fibrosis (METAVIR F0-2). Simeprevir is jointly developed by Medivir AB and
Janssen R&D Ireland, an affiliate of the Janssen Pharmaceutical Companies.

Further data will be presented this week at the 20th Conference on
Retroviruses and Opportunistic Infections (CROI) on March 6 in Atlanta,
Georgia, USA.

Cohort 1 of the phase IIa open-label COSMOS study randomized 80 genotype 1
patients into one of four arms including 150 mg of once-daily simeprevir plus
400 mg of sofosbuvir for 24 weeks with or without ribavirin or for 12 weeks
with or without ribavirin.

Summary of data available at the time of the interim analysis when submitted
to CROI:

Virologic response rates with 150 mg simeprevir (SMV) and 400 mg sofosbuvir
(SOF) q.d. with or without ribavirin (RBV).

               SMV + SOF +RBV   SMV + SOF   SMV + SOF +RBV   SMV + SOF
Patients n/N  24 weeks        24 weeks   12 weeks        12 weeks
               (n=24)           (n=15)      (n=27)           (n=14)
EoT            4/4              5/5         7/7              3/3
SVR4           3/3              3/3         5/5              3/3
SVR12          2/2              1/1         5/5              2/2

q.d.: en gång om dagen; EoT: behandlingsslut; SVR4 och SVR12: patienter med
odetekterbara nivåer HCV RNA ( HCV RNA (

The regimen of once-daily simeprevir and sofosbuvir with or without ribavirin
was generally well tolerated and no serious adverse events occurred during the
treatment period for the patients involved in the study.

The COSMOS (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1
infected patientS) study will also include a second cohort that will
investigate similar treatment regimens and durations in HCV genotype 1 prior
null-responder and treatment-naïve patients with METAVIR scores of F3-F4.

About the COSMOS Trial

COSMOS is a randomized, open-label study investigating the efficacy and safety
of 12 or 24 weeks of simeprevir and sofosbuvir with or without ribavirin in
HCV genotype 1 patients who are treatment naïve or have prior null response to
pegylated interferon and ribavirin therapy.

Cohort 1 of the COSMOS study enrolled 80 genotype 1 prior null-responder HCV
patients with METAVIR scores of F0-F2, who were stratified by IL28B status and
genotype 1 subtype, into one of four arms including once-daily simeprevir (150
mg) plus sofosbuvir (400 mg) for 24 weeks with or without ribavirin, or
once-daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks with or
without ribavirin.

Cohort 2 of the study will investigate similar treatment regimens and
durations in genotype 1 prior null-responder and treatment-naïve patients with
METAVIR scores of F3-F4. The Metavir score is used to quantify the degree of
inflammation and fibrosis of the liver. Liver fibrosis is scored on a
four-point scale.

About Simeprevir

Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB, is currently in late phase III studies as
a once-daily capsule (150 mg) taken in combination with pegylated interferon
and ribavirin for the treatment of genotypes 1 and 4 HCV.

Global phase III studies of simeprevir include QUEST-1 and QUEST-2 in
treatment-naïve patients, PROMISE in patients who have relapsed after prior
interferon-based treatment and ATTAIN in null-responder patients. In parallel
to these trials, phase III studies for simeprevir are ongoing in
treatment-naïve and treatment-experienced HIV-HCV co-infected patients, HCV
genotype 4 patients and Japanese HCV genotype 1 patients. Janssen
Pharmaceutical K.K. recently announced the submission of a new drug
application for simeprevir in Japan for the treatment of genotype 1 hepatitis
C.

Simeprevir is being studied in phase II interferon-free trials with and
without ribavirin in combination with:

· Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in
treatment-naïve genotype 1a and 1b HCV patients;

· Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in
treatment-naïve and previous null-responder genotype 1 HCV patients; and

· Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir
(BMS-790052) in treatment-naive and previous null-responder genotype 1 HCV
patients.

In addition, Janssen Pharmaceutical Inc. recently announced that it has
entered into a non-exclusive collaboration with Vertex Pharmaceuticals to
evaluate in a phase II study the safety and efficacy of an all-oral regimen of
simeprevir and Vertex’s investigational nucleotide analogue polymerase
inhibitor VX-135 for the treatment of HCV. As a first step, Janssen
Pharmaceutical Inc. will conduct a drug-drug interaction (DDI) study with
simeprevir and VX-135.

Janssen Pharmaceutical Inc. also recently announced plans to initiate a phase
IIa trial of an investigational interferon-free regimen with simeprevir,
TMC647055 and Idenix’s IDX719, a once-daily NS5A inhibitor, with and without
ribavirin.

For additional information about simeprevir clinical trials, please visit
www.clinicaltrials.gov.

About Sofosbuvir

Sofosbuvir (formerly referred to as GS-7977) is a once-daily nucleotide analog
polymerase inhibitor for the treatment of HCV infection being developed by
Gilead Sciences. Sofosbuvir is being evaluated as part of multiple therapeutic
regimens, including programs with RBV alone and in combination with peg-IFN
and RBV.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease and liver transplants, is a rapidly evolving
treatment area with a clear need for innovative treatments. Approximately 150
million people are infected with hepatitis C worldwide, and 350,000 people per
year die from the disease.

About Medivir AB

Medivir is an emerging research-based pharmaceutical company focused on
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 simeprevir, a novel protease
inhibitor in late phase III clinical development for hepatitis C that is being
developed in collaboration with Janssen R&D Ireland. Medivir has also a broad
product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website:
www.medivir.com

Medivir is a collaborative and agile pharmaceutical company with an R&D focus
on infectious diseases and a leading position in hepatitis C. We are
passionate and uncompromising in our mission to develop and commercialize
innovative pharmaceuticals that improve people’s lives.

This information was brought to you by Cision http://news.cision.com

Contact:

Medivir
Rein Piir
EVP Corporate Affairs & IR
Mobile: +46 708 537292.