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

Beerse, Belgium (ots/PRNewswire) -

- Research in haematological malignancies features VELCADE(R), 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 19th European Hematology
Association Congress (EHA) being held June 12-15, 2014 in Milan,
Italy.

Data include VELCADE(R) (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(R) (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
[http://www.investor.jnj.com/releasedetail.cfm?releaseid=788320 ],
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 negative or HHV-8 negative. The EMA has granted
Acceleration Assessment of the MAA. On March 20, 2014 [http://www.em
a.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_
authorisation/human/003708/WC500163475.pdf ] , 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(TM) was announced on April 23, 2014 [http://www.
jnj.com/news/all/SYLVANT-siltuximab-Receives-FDA-Approval-to-Treat-Mu
lticentric-Castlemans-Disease-MCD ] . 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
[http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=801510 ],
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(R) in the U.S., where it
received approval on November 13, 2013 [http://www.fda.gov/drugs/info
rmationondrugs/approveddrugs/ucm374857.htm ] 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 [http://www.fda.gov/newseven
ts/newsroom/pressannouncements/ucm385764.htm ] for the treatment of
patients with CLL who have received at least one prior therapy.

About Daratumumab

On August 30, 2012 [http://www.jnj.com/connect/news/all/janssen-b
iotech-announces-global-license-and-development-agreement-for-investi
gational-anti-cancer-agent-daratumumab ] , Genmab A/S granted
Janssen Biotech, Inc. an exclusive worldwide license to develop,
manufacture and commercialize daratumumab. Daratumumab is an
investigational human IgG1 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 [http://files.sha
reholder.com/downloads/JNJ/2326545610x0x659177/a8f5219f-2dae-4252-b57
8-e5baad03ff72/JNJ_News_2013_5_1_Financial_Releases.pdf ] ,
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&mid=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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