Efficacy and Safety Data from Phase 2B Trials of Janssen's Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the

   Efficacy and Safety Data from Phase 2B Trials of Janssen's Simeprevir in
 Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual
     Meeting of the American Association for the Study of Liver Diseases

- Data from Post Hoc Analyses of the ASPIRE and PILLAR Studies in Patients
with Metavir Scores of F3 and F4 Show Sustained Viral Response Compared to
Placebo -

PR Newswire

BOSTON, Nov. 10, 2012

BOSTON, Nov. 10, 2012 /PRNewswire/ --Janssen Pharmaceuticals, Inc. (Janssen)
today announced that the use of one once-daily pill of the investigational
protease inhibitor simeprevir (TMC435) administered with pegylated interferon
and ribavirin led to higher rates of sustained viral response at 24 weeks
(SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who
were treatment naive and treatment experienced with genotype 1 hepatitis C.
Simeprevir was also generally well tolerated and the overall incidence of
serious adverse events (AEs) was similar across all treatment arms. The data
from the Phase 2b PILLAR and ASPIRE trials were presented at the Annual
Meeting of the American Association for the Study of Liver Diseases (AASLD).

In treatment-naive patients with a Metavir score of F3 (PILLAR), the primary
endpoint of SVR24 was achieved in 79 percent of patients in the simeprevir
group compared to 72 percent in the control group (pegylated interferon and
ribavirin alone). In treatment-experienced patients with a Metavir score of F3
(ASPIRE), SVR24 was achieved in 48 percent of patients in the simeprevir group
compared to 8 percent in the control group. In treatment-experienced patients
with a Metavir score of F4 (ASPIRE), SVR was achieved in 62 percent of
patients in the simeprevir group compared to 0 percent in the control group.
In both the PILLAR and ASPIRE trials, serious AEs occurred in 7.6 percent of
patients receiving simeprevir plus pegylated interferon and ribavirin compared
to 9.8 percent of patients receiving pegylated interferon and ribavirin alone.

"Hepatitis C patients with Metavir scores of F3 and F4 have advanced fibrosis
of the liver and are harder to cure than those with limited fibrosis," said
Fred Poordad, M.D., chief medical officer of Alamo Medical Research Center and
investigator in the ASPIRE and PILLAR studies. "The results presented at AASLD
suggest that simeprevir could represent an important new treatment option for
people living with advanced hepatitis C if proven in advanced trials."

Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by
Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment
taken in combination with pegylated interferon and ribavirin for the treatment
of genotypes 1 and 4 chronic hepatitis C.It is also being studied in separate
Phase 2 trials with other direct-acting antiviral agents as part of
interferon-free regimens, with and without ribavirin. This includes a recently
initiated Phase 2a trial of an interferon-free regimen with simeprevir and
TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in
development for hepatitis C.

"We are encouraged by these data, which show sustained viral response and
tolerability in both treatment-naive and more challenging-to-cure patients,"
said Maria Beumont, M.D., Medical Leader for simeprevir, Janssen Research &
Development. "We look forward to further evaluating the utility of simeprevir
in combination with other agents for the treatment of hepatitis C."

About the PILLAR & ASPIRE Trials
In the two international, Phase 2b, randomized, double-blind,
placebo-controlled studies, patients were either treatment naive (PILLAR) or
treatment experienced (ASPIRE), and received pegylated interferon and
ribavirin alone or in combination with once-daily simeprevir. In PILLAR, 309
treatment-naive hepatitis C patients received either 75 or 150 mg of
once-daily simeprevir for 12 or 24 weeks plus pegylated interferon and
ribavirin for 24 or 48 weeks depending on their response to treatment. In
ASPIRE, 396 treatment-experienced patients received either 100 or 150 mg of
once-daily simeprevir for 12, 24 or 48 weeks plus pegylated interferon and
ribavirin for 48 weeks.

The post hoc analyses of PILLAR and ASPIRE presented at AASLD (abstracts 83
and 769) evaluated only patients receiving 150 mg of simeprevir and reporting
a Metavir score of F3 (PILLAR), or F3 and F4 (ASPIRE). 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. An F3 score means the patient has
numerous septa (fibrous tissue bands that can decrease the flow of blood
through the liver) without cirrhosis, while an F4 score means the patient has
cirrhosis.

About Simeprevir
Simeprevir (TMC435) is a NS3/4A protease inhibitor jointly developed by
Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being
studied in combination with pegylated interferon and ribavirin, and in
combination with direct-acting antiviral agents in all-oral interferon-free
regimens, with and without ribavirin.

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

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

  oJanssen's TMC647055 and ritonavir in treatment-naive, relapser or
    null-responder HCV genotype 1 patients;
  oGilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV
    genotype 1 patients; and
  oBristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or
    previous null-responder HCV genotype 1 patients.

In addition, Janssen recently announced that it has entered into a
non-exclusive collaboration with Vertex Pharmaceuticals Incorporated 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 will
conduct a drug-drug interaction (DDI) study with simeprevir and VX-135.

For additional information about simeprevir, 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 170
to 210 million people are infected with hepatitis C worldwide, with three to
four million people newly infected each year.

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. 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
Pharmaceuticals, Inc. 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 or other intellectual
property rights; 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 January 1, 2012. Copies of this Form 10-K, as well as subsequent
filings, are available online at www.sec.gov, www.jnj.comor on request from
Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson
undertake to update any forward-looking statements as a result of new
information or future events or developments.)

SOURCE Janssen Pharmaceuticals, Inc.

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