Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in

 Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once
Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis
                                  C Patients

PR Newswire

AMSTERDAM, April 23, 2013

AMSTERDAM, April 23, 2013 /PRNewswire/ --Janssen R&D Ireland (Janssen) today
announced primary efficacy and safety results from two global Phase 3 studies
demonstrating that use of the investigational protease inhibitor simeprevir
(TMC435) led to sustained virologic response 12 weeks after the end of
treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naive
genotype 1 chronic hepatitis C adult patients with compensated liver disease,
including all stages of liver fibrosis, when administered once daily with
pegylated interferon and ribavirin. In both studies, 50 percent of patients
receiving pegylated interferon and ribavirin alone achieved SVR12.

The data will be presented this week at The International Liver Congress 2013
of the European Association for the Study of the Liver (EASL) in Amsterdam,
The Netherlands. The QUEST-1 and QUEST-2 data will be discussed in an official
EASL press conference on April 24 at 11:00 a.m. CEST.

"More than 390 treatment-naive genotype 1 hepatitis C patients in 39 countries
received simeprevir as part of the Phase 3 QUEST trials," said Michael Manns,
M.D., professor and chairman, Department of Gastroenterology, Hepatology and
Endocrinology, Medical School of Hannover. "I am pleased to be a part of these
robust studies and look forward to seeing the results from upcoming trials of
simeprevir in treatment-experienced patients later this year."

In QUEST-1 and QUEST-2, patients were randomized to receive simeprevir or
placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 36
weeks. In findings related to a secondary endpoint, 85 percent (QUEST-1) and
91 percent (QUEST-2) of patients receiving simeprevir were able to shorten
therapy with pegylated interferon and ribavirin to 24 weeks due to meeting
response-guided therapy (RGT) criteria. Of those patients meeting RGT criteria
to stop treatment at 24 weeks, 91 percent (QUEST-1) and 86 percent (QUEST-2)
of patients achieved SVR12.

"Given the long-term health risks associated with hepatitis C, it's important
that physicians and patients have multiple options to treat the disease," said
Ira Jacobson, M.D., chief of the Division of Gastroenterology and Hepatology,
Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical
College, and attending physician, New York-Presbyterian Hospital/Weill Cornell
Medical Center. "The results of these Phase 3 trials suggest that simeprevir
could represent an important new treatment option for people living with
genotype 1 chronic hepatitis C."

Patients enrolled in QUEST-1 and QUEST-2 were stratified by HCV genotype 1
subtype and IL28B genotype. In QUEST-1, SVR12 rates among patients treated
with simeprevir with IL28B genotype variations were 94 percent for the CC
allele, 76 percent for the CT allele, and 65 percent for the TT allele. In
QUEST-2, SVR12 rates among patients treated with simeprevir with IL28B
genotype variations were 96 percent for the CC allele, 80 percent for the CT
allele, and 58 percent for the TT allele. Among patients with METAVIR scores
F3 and F4, 70 percent of patients treated with simeprevir in QUEST-1 and 66
percent of patients treated with simeprevir in QUEST-2 achieved SVR12. Among
patients with METAVIR scores F0 to F2, 83 percent of patients treated with
simeprevir in QUEST-1 and 85 percent of patients treated with simeprevir in
QUEST-2 achieved SVR12. The METAVIR score is used to quantify the degree of
inflammation and fibrosis of the liver and patients are scored on a four-point
scale.

"Patient response rates to hepatitis C therapy can be variable, depending on
factors such as viral genotype and subtype, and liver fibrosis. Patients with
genotype 1a, IL28B genotype TT and METAVIR scores of F3 and F4 can be
particularly challenging to cure," said Maria Beumont, M.D., medical leader
for simeprevir, Janssen. "Janssen is committed to advancing hepatitis C
therapy for even the most difficult-to-cure patients."

The most common adverse events seen in patients receiving simeprevir in
QUEST-1 were fatigue (42 percent versus 41 percent for placebo), itch (26
percent versus 16 percent for placebo), and headache (33 percent versus 39
percent for placebo). The most common adverse events seen in patients
receiving simeprevir in QUEST-2 were fatigue (37 percent versus 42 percent for
placebo), itch (25 percent versus 25 percent for placebo), headache (39
percent versus 37 percent for placebo), fever (31 percent versus 40 percent
for placebo), and influenza-like illness (26 percent versus 26 percent for
placebo). In QUEST-1, in both the simeprevir and placebo arms, 3 percent of
patients discontinued treatment due to an adverse event. In QUEST-2, 2 percent
of patients in the simeprevir arm and 1 percent of patients in the placebo arm
discontinued treatment due to an adverse event.

About QUEST-1 and QUEST-2

QUEST-1 and QUEST-2 are global, Phase 3, randomized, double-blind, placebo
controlled clinical trials assessing the efficacy, safety and tolerability of
simeprevir plus pegylated interferon and ribavirin versus pegylated interferon
and ribavirin alone in treatment-naive adult patients with genotype 1 chronic
hepatitis C with compensated liver disease, including all stages of liver
fibrosis.

In the QUEST-1 and QUEST-2 trials, 394 and 391 patients, respectively, 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 RGT
criteria. Patients in the simeprevir arm were considered to have met RGT
criteria if their HCV RNA levels were <25 IU/mL (detectable or undetectable)
at week 4 and <25 IU/mL undetectable at week 12. In patients meeting RGT
criteria, HCV therapy was stopped at week 24. All other patients continued
treatment until week 48.

About Simeprevir

Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly
developed by Janssen and Medivir AB for the treatment of genotype 1 chronic
hepatitis C in adult patients with compensated liver disease, including all
stages of liver fibrosis. Simeprevir is believed to work by blocking the
protease enzyme that enables the hepatitis C virus to survive and replicate in
host cells. Janssen recently announced the submission of new drug applications
for simeprevir in Japan and the United States for the treatment of genotype 1
hepatitis C, and anticipates submitting simeprevir for regulatory
authorization in the EU in the first half of 2013.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in
treatment-naive adult patients, PROMISE in patients who have relapsed after
prior interferon-based treatment and ATTAIN in null-responder adult
patients.In parallel to these trials, Phase 3 studies for simeprevir are
ongoing in treatment-naive and treatment-experienced HIV-HCV co-infected
patients and HCV genotype 4 patients. To date, 1,846 patients have been
treated with simeprevir in clinical trials.

Simeprevir is also being studied in Phase 2 interferon-free trials with and
without ribavirin in combination with:

  oJanssen's non-nucleoside inhibitor TMC647055 and ritonavir in
    treatment-naive genotype 1a and 1b HCV patients;
  oGilead Sciences, Inc.'s nucleotide inhibitor sofosbuvir (GS-7977) in
    treatment-naive and previous null-responder genotype 1 HCV patients; and
  oBristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir
    (BMS-790052) in treatment-naive and previous null-responder genotype 1 HCV
    patients.

In addition, Janssen has entered into a non-exclusive collaboration with
Vertex Pharmaceuticals to evaluate in a Phase 2 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 is conducting a drug-drug interaction (DDI) study with
simeprevir and VX-135. Janssen also has plans to initiate a Phase 2 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, 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, HCV 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 R&D Ireland

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. 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,
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; 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.)



SOURCE Janssen R&D Ireland

Website: http://www.janssenrnd.com
Contact: Media Contact: Daniel De Schryver, Mobile: +49 173 76 89 149; or
Media Contact: Craig Stoltz, Mobile: +1 (215) 325-3612; Investor Contact: Stan
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