Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis C from GlaxoSmithKline

Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis
                            C from GlaxoSmithKline

PR Newswire

TITUSVILLE, N.J., Oct. 8, 2013

TITUSVILLE, N.J., Oct. 8, 2013 /PRNewswire/ --Janssen Pharmaceuticals, Inc.
(Janssen) announced today the acquisition of the investigational compound
GSK2336805, an NS5a replication complex inhibitor in Phase 2 development for
the treatment of chronic hepatitis C, from an affiliate of GlaxoSmithKline
plc. Janssen has acquired all rights to develop and commercialize GSK2336805,
including in combination with other drugs. Financial details of the agreement
have not been disclosed.

Janssen plans to initiate Phase 2 studies to evaluate the use of GSK2336805 in
interferon-free combinations with the investigational protease inhibitor
simeprevir (TMC435) and TMC647055, Janssen's non-nucleoside polymerase
inhibitor, for the treatment of chronic hepatitis C in adult patients with
compensated liver disease.

"We're excited to add GSK2336805 to our existing portfolio of direct-acting
antivirals (DAAs). This addition will broaden our clinical development program
as we continue to look for new investigational interferon-free treatment
combinations to combat the hepatitis C virus," said Gaston Picchio, Hepatitis
Disease Area Leader, Janssen. "Janssen is dedicated to working with the
hepatitis C community to investigate our portfolio of DAAs in a number of
different treatment combinations and hepatitis C patient populations." 

About GSK2336805
GSK2336805 is an investigational once-daily NS5a replication complex inhibitor
in Phase 2 development for the treatment of chronic hepatitis C in adult
patients with compensated liver disease, including all stages of liver
fibrosis.

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed
by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 and
genotype 4 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.

Janssen is responsible for the global clinical development of simeprevir and
has acquired exclusive, worldwide marketing rights, except in the Nordic
countries. Medivir will retain marketing rights for simeprevir in these
countries. Simeprevir has been submitted for regulatory approval in the United
States, Canada and Europe, and was approved in September 2013 in Japan. To
date, more than 3,700 patients have been treated with simeprevir in clinical
trials.

Additionally, simeprevir is being studied in combination with several DAAs
with different mechanisms of action, with and without ribavirin, as part of
interferon-free regimens. These include:

  oThe Phase 2 COSMOS study of simeprevir and Gilead's nucleotide inhibitor
    sofosbuvir (GS-7977) in treatment-naive and previous null-responder
    genotype 1 hepatitis C patients, including patients with cirrhosis;
  oA Phase 2 study of simeprevir and Bristol-Myers Squibb's NS5A replication
    complex inhibitor daclatasvir in treatment-naive and previous
    null-responder genotype 1 hepatitis C patients; and
  oThe Phase 2 HELIX-1 study of simeprevir and Idenix's once-daily
    pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naive
    genotype 1b and genotype 4 hepatitis C patients.

For additional information about simeprevir, please
visitwww.clinicaltrials.gov.

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 – including approximately 3.2 million people in the United States –
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
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in infectious diseases and vaccines,
oncology, immunology, neuroscience, 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
Pharmaceuticals, Inc. and Janssen R&D Ireland are 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. 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
Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies
and/or Johnson & Johnson. Risks and uncertainties include, but are not
limited to, general industry conditions and competition; economic factors,
such as interest rate and currency exchange rate fluctuations; technological
advances, new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory approvals;
challenges to patents; impact of business combinations; 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; trends toward health care cost
containment; and increased scrutiny of the health care industry by government
agencies. A further list and description of these risks, uncertainties and
other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form
10-K, as well as subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies nor Johnson & Johnson undertake to update any
forward-looking statements as a result of new information or future events or
developments.)

Media Contact: Daniel De Schryver
Mobile: +49 173 76 89 149

Media Contact: Craig Stoltz
Mobile: +1 (215) 325-3612

Investor Contact: Stan Panasewicz
Office: +1 (732) 524-2524

Investor Contact: Louise Mehrotra
Office: +1 (732) 524-6491

SOURCE Janssen Pharmaceuticals, Inc.

Website: http://www.janssenrnd.com
 
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