Medivir: Primary efficacy and safety findings from phase III study of Simeprevir in treatment-experienced patients demonstrate

  Medivir: Primary efficacy and safety findings from phase III study of
  Simeprevir in treatment-experienced patients demonstrate sustained virologic
  response

Business Wire

STOCKHOLM -- May 21, 2013

Regulatory News:

Medivir AB (OMX:MVIR)(STO:MVIR-B) reports that its partner Janssen R&D Ireland
(Janssen) today announced primary efficacy and safety results from the global
phase III PROMISE study. Results demonstrated that use of the investigational
protease inhibitor simeprevir (TMC435) led to sustained virologic response 12
weeks after the end of treatment (SVR12) in 79 percent of
treatment-experienced genotype 1 chronic hepatitis C adult patients with
compensated liver disease, including all stages of liver fibrosis. Simeprevir
was administered once daily with pegylated interferon and ribavirin.

In the study, 37 percent of patients receiving pegylated interferon and
ribavirin (placebo) alone achieved SVR12. In the simeprevir arm, on-treatment
failure rates were 3 percent and relapse rates were 19 percent, compared to 27
percent and 48 percent in the placebo arm. All patients had previously
relapsed following pegylated interferon-based therapy.

The data were presented today as a late breaker oral presentation at Digestive
Disease Week 2013 in Orlando, Florida based on abstract number 869b,
“Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV
Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-Based
Therapy: Results From PROMISE, a Phase III Trial.”

“We are very pleased with these data from this phase III study in relapsers.
The data demonstrate high cure rates in these treatment-experienced patients.
Together with the very good safety profile and the fact that a large
proportion of the patients were eligible to end all treatments in a shorter
time frame as compared to current standard of care, should provide new hope
for large patient groups with this disease”, said Charlotte Edenius, EVP
Research and Development, Medivir AB.

Study design In PROMISE, patients were randomized to receive simeprevir or
placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 48
weeks. In findings related to a secondary endpoint, 93 percent of patients
receiving simeprevir were able to shorten therapy with pegylated interferon
and ribavirin to 24 weeks as a result of meeting response-guided therapy (RGT)
criteria. 83 percent of those patients meeting response-guided therapy
criteria to stop treatment at 24 weeks achieved SVR12.

Patients enrolled in PROMISE were stratified by hepatitis C virus (HCV)
genotype 1 subtype and IL28B genotype. SVR12 rates among patients treated with
simeprevir according to IL28B genotype were 89 percent for the CC allele, 78
percent for the CT allele, and 65 percent for the TT allele, compared to 53
percent for the CC allele, 34 percent for the CT allele and 19 percent for the
TT allele in the placebo arm.

Efficacy Among patients with METAVIR scores F0 to F2, 82 percent of patients
treated with simeprevir and 41 percent with placebo achieved SVR12. Among
patients with METAVIR scores F3 and F4, 73 percent and 74 percent of patients
treated with simeprevir and 20 percent and 26 percent treated with placebo
achieved SVR12, respectively. The METAVIR score is used to quantify the degree
of inflammation and fibrosis of the liver and patients are scored on a
five-point scale.

Safety The most common adverse events seen in patients receiving simeprevir in
PROMISE were fatigue (32 percent versus 42 percent for placebo), headache (32
percent versus 36 percent for placebo) and influenza-like illness (30 percent
versus 20 percent for placebo). In the simeprevir arm, rash (19 percent versus
14 percent for placebo), itching (24 percent versus 17 percent for placebo),
neutropenia (15 percent versus 17 percent for placebo), anemia (11 percent
versus 6 percent for placebo), increased bilirubin (6 percent versus 2 percent
for placebo), and photosensitivity conditions (4 percent versus none for
placebo) were also observed. One patient in the simeprevir arm and no patients
in the placebo arm discontinued treatment due to an adverse event.

About PROMISE

PROMISE is a global, phase III, randomized, double-blind, placebo-controlled
clinical trial assessing the efficacy, safety and tolerability of simeprevir
plus pegylated interferon and ribavirin versus pegylated interferon and
ribavirin alone in adult patients with genotype 1 chronic hepatitis C with
compensated liver disease, including all stages of liver fibrosis, who
relapsed after previous interferon-based therapy.

In the PROMISE trial, 393 patients were randomized to receive one 150 mg
capsule of simeprevir or placebo once daily plus pegylated interferon and
ribavirin for 12 weeks, followed by pegylated interferon and ribavirin alone
for either 12 or 36 weeks based on response-guided therapy criteria. Patients
in the simeprevir arm were considered to have met response-guided therapy
criteria if their HCV RNA levels were

About Simeprevir

Simeprevir is an investigational NS3/4A protease inhibitor jointly developed
by Medivir AB and Janssen R&D Ireland for the treatment of genotype 1 chronic
hepatitis C in adult patients with compensated liver disease, including all
stages of liver fibrosis. Simeprevir works by blocking the protease enzyme
that enables the hepatitis C virus to replicate in host cells. New drug
applications were recently submitted for simeprevir in Japan and the United
States for the treatment of genotype 1 hepatitis C, and a Marketing
Authorisation Application was submitted to the European Medicines Agency
seeking approval of simeprevir for the treatment of genotype 1 or genotype 4
chronic hepatitis C. The U.S. FDA has granted Priority Review to the New Drug
Application. Janssen Pharmaceutical K.K. also recently announced the
submission of a new drug application for simeprevir in Japan for the treatment
of genotype 1 hepatitis C.

Global phase III studies of simeprevir include PROMISE in adult patients who
have relapsed after prior interferon-based treatment, QUEST-1 and QUEST-2 in
treatment-naïve adult patients, and ATTAIN in prior null-responder adult
patients.In parallel to these trials, phase III studies for simeprevir are
ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected
patients and HCV genotype 4 patients.

Simeprevir is also 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 in
treatment-naive and previous null-responder genotype 1 HCV patients.

In addition, Janssen Pharmaceuticals, Inc. 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 Pharmaceuticals, Inc. is conducting
a drug-drug interaction (DDI) study with simeprevir and VX-135.

Janssen Pharmaceuticals, Inc. also has plans to initiate a phase II trial of
an investigational interferon-free regimen with simeprevir, TMC647055 and
Idenix’s IDX719, a once-daily, pan-genotypic NS5A inhibitor, with and without
ribavirin.

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

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 about 350,000
people per year die from the disease. When left untreated, hepatitis C can
cause significant damage to the liver including cirrhosis. Additionally,
hepatitis C may increase the risk of developing complications from cirrhosis,
which may include liver failure.

About Medivir

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.

(http://www.medivir.com)

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Contact:

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