OLYSIO™ (simeprevir) receives marketing authorisation in the European Union for the treatment of adults with hepatitis C

  OLYSIO™ (simeprevir) receives marketing authorisation in the European Union
  for the treatment of adults with hepatitis C genotype 1 and 4 infection

  Simeprevir provides a new triple therapy treatment option, as well as the
    first ever 12-week interferon-free and ribavirin independent treatment
 regimen, in combination with sofosbuvir, for appropriate patients in Europe

Business Wire

BEERSE, Belgium -- May 16, 2014

Janssen-Cilag International NV today announced that its next generation
protease inhibitor (PI) OLYSIO^TM (simeprevir) has been granted marketing
authorisation by the European Commission (EC) for the treatment of adults with
genotype 1 and 4  chronic hepatitisC (CHC), in combination with other
medicinal products, which includes^1:

Patient population           Treatment           Duration
Patients with HCV
genotype 1 or
4,regardless                  Simeprevir +
of prior treatment history     sofosbuvir,
and who are                    with or without      12 weeks
intolerant to or               ribavirin
ineligible for                 (RBV)
interferon (IFN) treatment


Treatment-naïve and prior                           24 weeks
relapse patients with
genotype                                            Treatment with
1 or 4 with or without         Simeprevir +         simeprevir must be
cirrhosis                      pegylated            initiated in
and those co-infected with     interferon           combination with PegIFN
human immunodeficiency         (PegIFN) + RBV       + RBV and
virus (HIV)                                         administered for 12
                                                    weeks, followed by an
                                                   additional
                                                    12 weeks of PegIFN + RBV
                                                    48 weeks
Prior non-responder
patients                                            Treatment with
(including partial and                              simeprevir must be
null                           Simeprevir +PegIFN   initiated in
responders) with HCV           + RBV                combination with PegIFN
genotype 1 or 4 and those                           + RBV and
co-infected with HIV                                administered for 12
                                                    weeks, followed
                                                   by an additional 36
                                                    weeks of PegIFN + RBV
                                                                             

This marketing authorisation represents a significant milestone in the
development of new triple therapy hepatitis C (HCV) treatment options for
genotype 1 and 4 patients. It also includes simeprevir as part of an all oral
12-week IFN-free direct-acting antiviral (DAA) regimen with or without RBV, in
genotype 1 or 4 patients, who are intolerant to or ineligible for IFN
treatment.^1

“The EC marketing authorisation for simeprevir is a great milestone as it adds
an important new treatment option for patients, demonstrating the continued
role of triple therapy in the treatment of HCV. In addition, the introduction
of an all oral, 12-week interferon-free treatment regimen provides a new
option for sustained virologic response in HCV patients with genotypes 1 or 4
intolerant to or ineligible for interferon-based treatment,” said Thomas
Stark, Medical Director, Janssen EMEA.

HCV represents a major global public health concern. There are an estimated
nine million people^2 living with HCV in Europe which, if untreated, can cause
severe damage to the liver, including cirrhosis and hepatocellular carcinoma
(HCC). HCV represents a leading cause of liver transplantation in Europe.^3
Whilst the number of patients being newly diagnosed with HCV is declining, it
takes approximately 20 – 30 years for symptoms to appear, with HCV cases
expecting to peak between 2030 and 2035.^4,5

Dr Andrew Ustianowski, Chair of the British Viral Hepatitis Group and
Consultant in Infectious Diseases at North Manchester General Hospital,
commented: “The treatment environment in hepatitis C infection is evolving
rapidly. Simeprevir is a well-tolerated and efficacious addition to our
therapies against hepatitis C, and is a very welcome development for both
those with genotype 1 and those with genotype 4.”

The EC marketing authorisation for simeprevir with PegIFN + RBV is based on a
clinical trial programme involving three pivotal Phase 3 studies, with over
1000 patients. The trials, QUEST-1, QUEST-2^6 and PROMISE^7, explored the use
of simeprevir in combination with PegIFN + RBV in treatment-naïve patients and
patients who have relapsed after prior interferon-based treatment. All three
studies met their primary endpoints and demonstrated that simeprevir, in
combination with PegIFN + RBV, achieves significant sustained virological
response rates when compared with PegIFN + RBV alone.

The EC marketing authorisation for the combination of simeprevir and
sofosbuvir also contains results from the Phase 2 study, COSMOS, in
treatment-naïve patients. This was based upon prior null responder and
treatment-naïve patients.^8

Simeprevir is taken once-daily for 12 weeks, with treatment-naïve and
prior-relapser patients receiving pegylated interferon and ribavirin for 24
weeks, and for 48 weeks total by those shown to be prior non-responder
patients (including partial and null responders)^1. It is generally well
tolerated, with the most common adverse events reported in clinical trials
(incidence ≥ 5%) including nausea, rash, pruritus, dyspnoea, blood bilirubin
increase and photosensitivity reaction.^1

In March 2013, simeprevir was approved for the treatment of genotype 1 HCV in
Japan, in Canada in September 2013, and the U.S. in November 2013, with the
most recent approval occurring in Russia in March 2014. Following the EC
marketing authorisation, it is anticipated that simeprevir will be available
across a number of European Union countries, in conjunction with
reimbursement, in the second half of 2014.

                                    -ENDS-

About Simeprevir

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D
Ireland and Medivir AB.

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 authorisation held by Janssen-Cilag International NV. Simeprevir
was approved for the treatment of genotype 1 hepatitis C in September 2013 in
Japan, in November 2013 in Canada and the U.S., and in March 2014 in Russia.

About Hepatitis C

HCV is a major global public health concern. It is a serious and complex
blood-borne virus which manifests itself through complications of the liver.
If left untreated, it can cause significant and potentially fatal damage to
the liver including cirrhosis, leading to eventual transplantation. In Europe
HCV is a leading cause of liver transplantation.^3

The World Health Organisation (WHO) and the European Association for the Study
of the Liver (EASL) estimate that 150 million people worldwide were
chronically infected with HCV in 2011.^9 The virus is responsible for 350,000
deaths globally^9 and 86,000 deaths in the European region each year.^10 As
the disease is often asymptomatic in its early stages it can be difficult to
diagnose and treat. Up to 90 percent of those with HCV do not clear the virus
without treatment and become chronically infected.^11 The WHO estimates that
20 percent of people with HCV will develop cirrhosis and, of those, up to 20
percent may progress to liver cancer.^12 Genotype 1 HCV is the most prevalent
form of the virus worldwide^13 and one of the most challenging to treat
successfully.

About Janssen Pharmaceutical Companies

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology, immunology, neuroscience, infectious disease, and
cardiovascular and metabolic diseases. Driven by our commitment to patients,
Janssen develops innovative products, services and healthcare solutions to
help people throughout the world.

More information can be found at www.janssen-emea.com

Janssen Forward Looking Statement

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 and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to:
economic factors, such as interest rate and currency exchange rate
fluctuations; competition, including 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; general industry
conditions including 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 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. Neither Janssen nor Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future events or
developments.

References

^1 Olysio SmPC. Accessed March 2014.

^2 Hatzakis A et. al. The state of hepatitis B and C in Europe: report from
the hepatitis B and C summit conference. Journal of Viral Hepatitis,
2011:18,1-16.

^3 European Association for the Study of the Liver. EASL The Burden of Liver
Disease in Europe. Available from
http://www.easl.eu/assets/application/files/54ae845caec619f_file.pdf. Accessed
April 2014.

^4 Menzin J et al. BMC Health Services Research 2012; 12(459).

^5 Rein DB et al. Forecasting the morbidity and mortality associated with
prevalent cases of pre-cirrhotic chronic hepatitis C in the United States.
Abstract Digestive and Liver Disease 2011. Available at:
http://www.sciencedirect.com/science/article/pii/S1590865810001702 Accessed
March 2014.

^6 Foster GR et al. Simeprevir (TMC435) with peginterferon/ribavirin for the
treatment of chronic HCV genotype 1 infection in treatment-naïve European
patients in the QUEST 1 and QUEST 2 Phase III studies. Abstract 1127. Poster
presentation at the European Association for the Study of the Liver 2014.

^7 Forns X et al. The PROMISE study, Simeprevir (TMC 435) with
peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in
European patients who relapsed after previous interferon-based therapy.
Abstract 013. Oral presentation the European Association for the Study of the
Liver 2014.

^8 Lawitz M et al. The COSMOS cohort 2 study, abstract presented at the
European Associate for the Study of the Liver (EASL) 2014.

^9 World Health Organisation. Hepatitis C. Fact sheet N. 164. Available at:
http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed March 2014.

^10 Muhlberger M et al. HCV-related burden of disease in Europe: a systematic
assessment of incidence, prevalence, morbidity, and mortality. BMC Public
Health 2009:9,34.

^11 World Health Organisations (WHO). “Hepatitis C: About HCV Infection.”
Available at:
www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html Accessed
March 2014.

^12 World Health Organisation. Hepatitis C. Available at:
http://www.who.int/csr/disease/hepatitis/Hepc.pdf. Accessed March 2014

^13 Zein NN. Clinical Significance of Hepatitis C Virus Genotypes. Clin.
Microbiol. Rev. April 2000:13(2),223-235.

Contact:

Janssen-Cilag
Media Contact: Hans Vanavermaete (Janssen EMEA)
Mobile: +32 (0) 478 447278
or
Media Contact: Rikki Jones (Team Chemistry)
Mobile: +44 (0) 75 9591 9643
or
Investor Contact: Stan Panasewicz
Office: +1 (732) 524 2524
or
Investor Contact: Louise Mehrotra
Office: +1 (732) 524 6491
 
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