Janssen Initiates Phase 3 OPTIMIST Trials of Once-Daily Simeprevir in Combination with Once-Daily Sofosbuvir for the Treatment

    Janssen Initiates Phase 3 OPTIMIST Trials of Once-Daily Simeprevir in
Combination with Once-Daily Sofosbuvir for the Treatment of Genotype 1 Chronic
                                 Hepatitis C

OPTIMIST represents the first Phase 3 studies of the two treatments in a
regimen without interferon and ribavirin

PR Newswire

CORK, Ireland, April 2, 2014

CORK, Ireland, April 2, 2014 /PRNewswire/ --Janssen R&D Ireland (Janssen)
announced today that two Phase 3 trials are recruiting patients to examine the
efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination
with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype
1 hepatitis C virus (HCV) infection in treatment-naive and
treatment-experienced patients with and without cirrhosis. Simeprevir is
approved in the U.S., Canada, Japan and Russia for the treatment of genotype 1
HCV as part of an antiviral treatment regimen in combination with pegylated
interferon and ribavirin and the Committee for Medicinal Products for Human
Use has adopted a positive opinion, recommending Marketing Authorisation in
the European Union for the use of simeprevir in combination with other
medicinal products for the treatment of chronic HCV. The combination of
simeprevir and sofosbuvir was previously evaluated in the Phase 2 COSMOS
trial.

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"The combination of simeprevir and sofosbuvir with and without ribavirin
demonstrated efficacy and safety in treatment-naive and treatment-experienced
patients, including those with cirrhosis, in the Phase 2 COSMOS study," said
Gaston Picchio, Hepatitis Disease Area Leader, Janssen. "The initiation of
these Phase 3 clinical trials is the latest fulfillment of Janssen's
commitment to investigate the utility of simeprevir for patients with chronic
hepatitis C infection."

The first trial, known as OPTIMIST-1 (Optimal Treatment with a simeprevir and
sofosbuvir Therapy) or TMC435HPC3017, is a Phase 3, multicenter, open-label,
randomized study investigating the efficacy and safety of simeprevir 150 mg in
combination with sofosbuvir 400 mg. The combination will be administered once
daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without
cirrhosis who are HCV treatment naive or treatment experienced. The second
trial, known as OPTIMIST-2 or TMC435HPC3018, is a Phase 3, multicenter,
open-label, single-arm study investigating the efficacy and safety of
simeprevir 150 mg in combination with sofosbuvir 400 mg. The combination will
be administered once daily for 12 weeks in HCV genotype 1 infected patients
with cirrhosis who are HCV treatment naive or treatment experienced. Ribavirin
will not be administered in the OPTIMIST trials.

The primary efficacy endpoint in each study is the proportion of patients
achieving sustained virologic response 12 weeks after the end of treatment
(SVR12). The studies will seek to enroll approximately 400 patients in the
U.S. and Canada.

The final cohort 1 study results (SVR12) and the interim cohort 2 study
results (SVR4) from the COSMOS study were presented as a late-breaker abstract
at the American Association for the Study of Liver Diseases (AASLD) Annual
Meeting 2013 in Washington, D.C. Final cohort 2 results (SVR12) have been
accepted for presentation at the International Liver Congress 2014™ of the
European Association for the Study of the Liver (EASL) on April 12. For
additional information, including inclusion and exclusion criteria for these
trials, please visit www.clinicaltrials.gov.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D
Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C
infection in combination with pegylated interferon and ribavirin in HCV
genotype 1 infected patients with compensated liver disease, including
cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and
has exclusive, worldwide marketing rights, except in the Nordic countries.
Medivir AB retains marketing rights for simeprevir in these countries under
the marketing authorization held by Janssen-Cilag International NV. Simeprevir
was approved for the treatment of genotype 1 hepatitis C in September 2013 in
Japan and in November 2013 in Canada and the U.S. A Marketing Authorisation
Application was submitted to the European Medicines Agency (EMA) in April 2013
by Janssen-Cilag International NV seeking approval of simeprevir for the
treatment of genotype 1 or genotype 4 chronic hepatitis C and the Committee
for Medicinal Products for Human Use (CHMP) has adopted a positive opinion,
recommending Marketing Authorisation in the European Union for the use of
simeprevir in combination with other medicinal products for the treatment of
chronic HCV. This application is under review by the EMA.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease, is the focus of a rapidly evolving treatment
landscape. Approximately 150 million people are infected with hepatitis C
worldwide and 350,000 people per year die from the disease globally. 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 Janssen Pharmaceutical Companies
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen R&D Ireland is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Please visit
http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995 regarding product research
and development. The reader is cautioned not to rely on these forward-looking
statements. These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from the
expectations and projections of Janssen R&D Ireland and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to: uncertainties
inherent in research and development, including the ability to carry out the
clinical trials as planned, the possibility of unfavorable clinical trial
results and challenges in obtaining regulatory approvals; competition,
including technological advances, new products and patents attained by
competitors; challenges to patents; changes in behavior and spending patterns
or financial distress of purchasers of health care products and services;
changes to governmental laws and regulations and domestic and foreign health
care reforms; and general industry conditions including trends toward health
care cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended December 29, 2013, including in
Exhibit 99 thereto, and our subsequent filings with the Securities and
Exchange Commission. Copies of these filings are available online at
www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the
Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future events or
developments.)

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SOURCE Janssen R&D Ireland

Website: http://www.janssenrnd.com
 
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