Janssen to Exhibit Expanding Portfolio of Research at 2014 European Hematology Association (EHA) Annual Meeting

Janssen to Exhibit Expanding Portfolio of Research at 2014 European Hematology
                       Association (EHA) Annual Meeting

  PR Newswire

  BEERSE, Belgium, May 23, 2014

BEERSE, Belgium, May 23, 2014 /PRNewswire/ --

  *Research in haematological malignancies features VELCADE ^® , siltuximab,
    ibrutinib and daratumumab 
  *Note: This release corresponds to EHA abstracts S1345,  P958, P957, P369,
    P353, P960, P1211, P1209,  P461,  P356, P350, P434, P109 

Janssen Pharmaceutica NV announced data related to four compounds have been
selected for presentation at the 19 ^th European Hematology Association
Congress (EHA) being held June 12-15, 2014 in Milan, Italy.

Data include VELCADE ^® (bortezomib), a first-in-class proteasome inhibitor to
treat patients with multiple myeloma, which has also been investigated as a
treatment for newly diagnosed patients with mantle cell lymphoma (MCL);
siltuximab, an anti-interleukin-6 (IL-6) chimeric monoclonal antibody which
recently received a positive CHMP opinion for the treatment of multicentric
Castleman's disease (MCD). Data will also be presented for ibrutinib, an
investigational compound which targets and blocks a specific protein (Bruton's
tyrosine kinase) inhibiting cancer cell survival, in relapsed/refractory
chronic lymphocytic leukaemia (CLL), MCL and other B-cell malignancies, and
daratumumab, an investigational human CD38 monoclonal antibody being studied
in multiple myeloma and other B-cell malignancies.

"Janssen has had a momentous year in haematology and has made significant
progress across our portfolio since last year's EHA meeting. We are looking
forward to presentations this year, which highlight important clinical data
across our haematology compounds," said Jane Griffiths, Company Group Chairman
of Janssen Europe, the Middle East and Africa (EMEA). "At Janssen, we are
committed to pursuing compelling science, where the need, and opportunity for
impact, are greatest for patients."

List of Company-Sponsored Research to Be Presented 

VELCADE 

The following VELCADE data have been accepted for presentation at EHA and were
sponsored by Janssen or jointly sponsored by Janssen and its collaboration
partner Millennium: The Takeda Oncology Company, a wholly owned subsidiary of
Takeda Pharmaceutical Company Limited:

  *Phase  3  study  of  frontline  rituximab,  cyclophosphamide,
    doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib
    (VR-CAP) in transplantation-unsuitable mantle cell lymphoma (MCL) patients
     (Abstract S1345) Oral abstract session: Aggressive Non-Hodgkin lymphoma
    - Clinical. Sunday 15 June 2014, 10:30-10:45 CEST in Auditorium (NW -
    Level 3) Lead Author: Tadeusz Robak, M.D., PhD, Department of Hematology,
    Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland
  *Subcutaneous (SC) versus intravenous (IV) bortezomib in patients with
    relapsed multiple myeloma (MM): subanalysis of patients with renal
    impairment in the phase 3 MMY-3021 study. (Abstract P958)  Poster
    presentation session: Myeloma and other monoclonal gammopathies - Clinical
    3 (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in e-Poster Area (NW -
    Level 0) Lead Author: Philippe Moreau, M.D., University Hospital, Nantes,
    France
  *First-line therapy for multiple myeloma (MM): results from the second
    interim analysis of the real-world, international, non-interventional
    EMMOS study. (Abstract P957)  Poster presentation session: Myeloma and
    other monoclonal gammopathies - Clinical 3 (Poster). Saturday 14 June
    2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead Author:
    Mohamad Mohty, M.D., PhD, Saint-Antoine Hospital, Pierre & Marie Curie
    University, Paris, France
  *Randomized phase 2 study of bortezomib, thalidomide, and dexamethasone
    with or without cyclophosphamide as induction therapy in previously
    untreated multiple myeloma (MM): Long-term follow-up results. (Abstract
    P369)  Poster presentation session: Myeloma and other monoclonal
    gammopathies - Clinical 2 (Poster). Friday 13 June 2014, 17:45-19:00 CEST
    in Poster Area (NW - Level 0) Lead Author: Heinz Ludwig, M.D., Wilhelminen
    Cancer Research Institute, c/o First Department of Medicine, Center for
    Oncology, Haematology and Palliative Care, Wilhelminenspital, Vienna
  *Preliminary pre-randomization results from a phase 3 study of frontline
    subcutaneous (SC) bortezomib-based induction and consolidation in
    transplantation-eligible multiple myeloma (MM) patients (PTS). (Abstract
    P353)  Poster presentation session: Myeloma and other monoclonal
    gammopathies - Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST
    in Poster Area (NW - Level 0) Lead Author: Noemi Horvath, M.D., Division
    of Haematology, SA Pathology/Royal Adelaide Hospital, Adelaide, SA
  *Effects of single-agent bortezomib (BTZ) as post-transplant consolidation
    on multiple myeloma (MM)-related bone disease: First results from a
    multicenter, randomized phase 2 study. (AbstractP960)  Poster
    presentation session: Myeloma and other monoclonal gammopathies - Clinical
    3 (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in e-Poster Area (NW -
    Level 0) Lead Author: Orhan Sezer, M.D., PhD., Department of Hematology
    and Stem Cell Transplantation, Memorial Hospital, Istanbul

Siltuximab

Two Janssen-sponsored abstracts for siltuximab have been accepted for
presentation at EHA:

  *Inflammatory and anemia-related markers in a phase 2, randomized,
    double-blind, placebo controlled study of siltuximab (ANTI-IL 6 monoclonal
    antibody) in multicentric Castleman's disease patients. (Abstract P1211) 
    Poster presentation session: Non-malignant hematologic disorders (Poster).
    Saturday 14 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead
    Author : Corey Casper, M.D., MPH, Fred Hutchinson Cancer Research Center,
    Seattle, WA
  *Improvements in hemoglobin levels and fatigue in a randomized, double
    blinded, placebo controlled study (MCD3282001) of siltuximab in patients
    with multicentric Castleman's Disease (MCD). (Abstract P1209)  Poster
    presentation session: Non-malignant hematologic disorders (Poster).
    Saturday 14 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead
    Author: Frits van Rhee, M.D., Ph.D., Myeloma Institute for Research and
    Therapy, University of Arkansas for Medical Sciences, Little Rock, AR,
    United States

Ibrutinib 

Ibrutinib data will be featured in more than two studies selected for
presentation, and sponsored by either Janssen or its collaboration partner,
Pharmacyclics, Inc.:

  *Randomized comparison of ibrutinib versus ofatumumab in previously treated
    chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the
    phase III RESONATE (TM) trial.  Oral session: Presidential Symposium.
    Saturday 14 June 2014, 14:45-15:00 CEST in Room Gold (SW- Level 2) Lead
    Author: Peter Hillmen, MBChB, PhD, St. James University Hospital, Leeds,
    United Kingdom
  *Phase 2 study of ibrutinib in relapsed or refractory mantle cell lymphoma:
    Updated safety analysis on prevalence of infection, diarrhea, and bleeding
    over time. (Abstract P461)  Poster presentation session: Aggressive
    Non-Hodgkin lymphoma - Clinical 1 (Poster). Friday 13 June 2014,
    17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Simon Rule,
    M.D., Department of Haematology, Derriford Hospital, Plymouth, United
    Kingdom

Daratumumab 

Four daratumumab abstracts have been accepted for presentation and were
jointly sponsored by Janssen and Genmab A/S. Janssen licensed daratumumab from
Genmab A/S in 2012 and is working with the company to fully transition the
development programme to Janssen. The selected daratumumab abstracts at EHA
include:

  *Dose-dependent efficacy of daratumumab (DARA) as monotherapy in patients
    with relapsed or refractory multiple myeloma (RR MM).  (Abstract P356) 
    Poster presentation session: Myeloma and other monoclonal gammopathies -
    Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area
    (NW - Level 0) Lead Author: Henk Lokhorst, M.D., Ph.D., UMC Utrecht,
    Utrecht, Netherlands, Utrecht, Netherlands
  *Safety and efficacy of daratumumab with lenalidomide and dexamethasone in
    relapsed or relapsed, refractory multiple myeloma.  (Abstract P350) 
    Poster presentation session: Myeloma and other monoclonal gammopathies -
    Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area
    (NW - Level 0) Lead Author: Torben Plesner, M.D., Vejle Hospital, Vejle,
    Denmark
  *Daratumumab treatment in combination with CHOP or R-CHOP results in the
    inhibition or regression of tumours in preclinical models of non-Hodgkins
    lymphoma.  (Abstract P434)  Poster presentation session: Non-Hodgkin &
    Hodgkin lymphoma - Biology 1 (Poster). Friday 13 June 2014, 17:45-19:00
    CEST in Poster Area (NW - Level 0) Lead Author: Parul Doshi, M.D.,
    Oncology Translational Medicine and Early Development.
  *Daratumumab treatment alone or in combination with vincristine results in
    the inhibition of tumor growth and long term survival in preclinical
    models of acute lymphocytic leukemia.  (Abstract P109)  Poster
    presentation session: Acute lymphoblastic leukemia - Biology 1 (Poster).
    Friday 13 June 2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead
    Author: Parul Doshi, M.D., Oncology Translational Medicine and Early
    Development.

About VELCADE ^®  (bortezomib) ^[ ^1] VELCADE (bortezomib) is a medicine used
to treat the blood-based cancer known as multiple myeloma. It contains an
active substance called bortezomib and is the first in a specific class of
medicines known as proteasome inhibitors. Proteasomes are present in all cells
and play an important role in controlling cell function, growth and also how
cells interact with the other cells around them. Bortezomib reversibly
interrupts the normal working of cell proteasomes causing myeloma cancer cells
to stop growing and die.

VELCADE is the market leader in the treatment of frontline non-transplant
eligible multiple myeloma. It is co-developed by Millennium/Takeda and Janssen
Pharmaceutical Companies. Millennium is responsible for commercialisation of
VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for
commercialisation in Europe and the rest of the world. Takeda Pharmaceutical
Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan.
VELCADE is approved in more than 90 countries and has been used to treat more
than 550,000 patients worldwide.

About siltuximab Siltuximab is an anti-interleukin-6 (IL-6) chimeric
monoclonal antibody that binds to human IL-6. IL-6 is a multifunctional
cytokine produced by various cells such as T cells, B cells, monocytes,
fibroblasts and endothelial cells. Dysregulated overproduction of IL-6 from
activated B cells in affected lymph nodes has been implicated in the
pathogenesis of, or mechanism causing, MCD. ^[2] Information about ongoing
studies with siltuximab can be found at http://www.clinicaltrials.gov .

On September 3, 2013 , Janssen Research & Development, LLC announced
simultaneous submissions of a Biologic License Application (BLA) to the U.S.
FDA and a Marketing Authorisation Application (MAA) to the European Medicines
Agency (EMA) for siltuximab for the treatment of patients with MCD who are HIV
negativeor HHV-8 negative. The EMA has granted Acceleration Assessment of the
MAA. On March 20, 2014 , the Committee for Medicinal Products for Human Use
(CHMP) of the EMA adopted a positive opinion recommending the marketing
authorization of siltuximab for the treatment of adult patients with MCD who
are HIV negative or HHV-8 negative. The U.S. Food and Drug Administration's
approval of SYLVANT™ was announced on April 23, 2014 . Siltuximab has been
granted orphan drug status in MCD in the U.S. and European Union.

About Ibrutinib Ibrutinib is an investigational compound within a class of
medicines called Bruton's tyrosine kinase (BTK) inhibitors. BTK is an
important protein involved in mediating the cellular signalling pathways which
control B cell maturation and survival. In malignant B cells, there is
excessive signalling through the B cell receptor (BCR) and other signalling
pathways, which includes BTK. The malignant cell ignores the natural signal to
die and continues to develop and proliferate. Malignant cells migrate and
adhere to protective environmental areas such as the lymph nodes where they
proliferate and survive. Ibrutinib is specifically designed to target and
inhibit BTK. Ibrutinib forms a strong covalent bond with BTK, which inhibits
the excessive transmission of cell survival signals within the malignant B
cells and stops their excessive build up in these protected environmental
areas. The efficacy and safety of ibrutinib alone and in combination with
other treatments is being studied in several blood cancers including chronic
lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom's
macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), follicular
lymphoma (FL) and multiple myeloma (MM). ^[3-7]

On October 30, 2013 , Janssen-Cilag International NV submitted a New Marketing
Authorisation Application (MAA) to the European Medicines Agency (EMA) for
ibrutinib for the treatment of adult patients with relapsed or refractory
CLL/small lymphocytic lymphoma (SLL) or relapsed or refractory MCL.

Ibrutinib is marketed as IMBRUVICA ^® in the U.S., where it received approval
on November 13, 2013 from the U.S. Food and Drug Administration (FDA) for the
treatment of patients with MCL who have received at least one prior therapy,
followed by further indication approval on February 12, 2014 for the treatment
of patients with CLL who have received at least one prior therapy.

About Daratumumab 

On August 30, 2012 , Genmab A/S granted Janssen Biotech, Inc. an exclusive
worldwide license to develop, manufacture and commercialize daratumumab.
Daratumumab is an investigational human IgG [1] monoclonal antibody (mAb) that
binds with high affinity to CD38 on surface of multiple myeloma cells and
induces rapid tumor cell death through diverse mechanisms of action.
Daratumumab is in Phase 3 clinical development for multiple myeloma, and may
also have potential in other malignant and pre-malignant diseases on which
CD38 is expressed. On May 1, 2013 , daratumumab was granted Breakthrough
Therapy Designation by the FDA for the treatment of patients with multiple
myeloma who have received at least three prior lines of therapy including a
proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are
double refractory to a PI and IMiD.

About Janssen  

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology (e.g. multiple myeloma and prostate cancer), immunology
(e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain),
infectious disease (e.g. HIV/AIDS, hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes). Driven by our
commitment to patients, we develop sustainable, integrated healthcare
solutions by working side-by-side with healthcare stakeholders, based on
partnerships of trust and transparency. More information can be found on
http://www.janssen-emea.com . Follow us on http://www.twitter.com/janssenEMEA
for our latest news.

Janssen Pharmaceutica NV, Janssen Research & Development, LLC, Janssen
Biotech, Inc., and Janssen-Cilag International NV are part of the Janssen
Pharmaceutical Companies of Johnson & Johnson.

Janssen in Oncology

In oncology, our goal is to fundamentally alter the way cancer is understood,
diagnosed and managed, reinforcing our commitment to the patients who inspire
us. In looking to find innovative ways to address the cancer challenge, our
primary efforts focus on several treatment and prevention solutions. These
include a focus on hematologic malignancies, prostate cancer and lung cancer;
cancer interception with the goal of developing products that interrupt the
carcinogenic process; biomarkers that may help guide targeted, individualized
use of our therapies; as well as safe and effective identification and
treatment of early changes in the tumour microenvironment.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995 regarding product
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 any of the Janssen Pharmaceutical Companies 
or Johnson & Johnson. Risks and uncertainties include, but are not limited to:
challenges inherent in new product development, including obtaining regulatory
approvals; competition, including technological advances, new products and
patents attained by competitors; challenges to patents; changes in behaviour
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 http://www.sec.gov , http://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.)

References: 

1.VELCADE EPAR Available at:
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000539/human_med_001130.jsp&murl=menus/medicines/medicines.jsp∣=WC0b01ac058001d124
    . Accessed April 2014.
2.El-Osta HE, Kurzrock R. Castleman's disease: from basic mechanisms to
    molecular therapeutics. Oncologist. 2011;16:497-511.
3.Qiu Y, Kung HJ. Signaling network of the Btk family kinases. Oncogene .
    2000;19:5651-61.
4.Shaffer AL, Rosenwald A, Staudt LM. Lymphoid malignancies: the dark side
    of B-cell differentiation. Nat Rev Immunol . 2002;2:920-32.
5.Puri KD, di Paolo JA, Gold MR. B-cell receptor signaling inhibitors for
    treatment of autoimmune inflammatory diseases and B-cell malignancies. Int
    Rev Immunol. 2013;32:397-427.
6.Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a
    therapeutic target in CLL. Blood. 2012;120:1175-84.
7.Akinleye A, Chen Y, Mukhi N, Song Y, Liu D. Ibrutinib and novel BTK
    inhibitors in clinical development. J Hematol Oncol. 2013;6:59.

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