New Marketing Authorisation Application Submitted to EMA for Ibrutinib for the Treatment of Two Forms of Blood Cancer

  New Marketing Authorisation Application Submitted to EMA for Ibrutinib for
  the Treatment of Two Forms of Blood Cancer

  The submission is for chronic lymphocytic leukemia (CLL)/small lymphocytic
leukemia (SLL) and mantle cell lymphoma (MCL), two difficult-to-treat diseases

Business Wire

BEERSE, Belgium -- October 30, 2013

Janssen-Cilag International NV (Janssen) announced today it has submitted a
Marketing Authorization Application (MAA) to the European Medicines Agency
(EMA) for ibrutinib for the treatment of adult patients with relapsed or
refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)
or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood
cancer.

Ibrutinib is administered orally, once-daily and is the first in a class of
medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data suggest
ibrutinib covalently bonds to BTK in malignant B cells, shutting down major
proliferation and survival pathways. Ibrutinib is being developed by Janssen
with Pharmacyclics, Inc. for the treatment of several forms of blood cancer.
If approved, ibrutinib will be the first commercially available therapy
targeting BTK.

“The EMA Marketing Authorisation Application is an important milestone in the
development of ibrutinib,” said Jane Griffiths, Group Company Chairman of
Janssen Europe, the Middle East and Africa (EMEA). "At Janssen, we are
dedicated to developing solutions that prolong and improve the lives of
patients. If approved, ibrutinib will address a great unmet need for patients
with CLL/SLL and MCL who have previously failed or become resistant to
previous treatment.”

The EMA filings follow the New Drug Application submission of ibrutinib to the
U.S. Food and Drug Administration which was announced on 10 July 2013, for its
use in the treatment of previously treated patients with CLL/SLL or MCL.

CLL/SLL and MCL belong to a group of blood cancers, known as B-cell
malignancies, originating from B cells, a type of white blood cell
(lymphocyte).^1 CLL/SLL and MCL, are complex diseases that can be challenging
to treat. As a result, many patients will relapse after a specific treatment
and may require multiple treatments over the course of their disease.

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About Ibrutinib

Ibrutinib is the first in a class of medicines called Bruton's tyrosine kinase
(BTK) inhibitors. BTK is an important protein involved in mediating the
cellular signaling pathways which control B cell maturation and survival. In
malignant B cells, there is excessive signaling through the B cell receptor
signaling (BCR) pathway, 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 the first in a new
class of drugs 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.^2,3,4,5,6

About Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL)

CLL is a usually slow growing blood cancer that most commonly originates from
B cells, a type of white blood cell (lymphocyte) that develops in the bone
marrow. B cells are part of the immune system and play an important role in
fighting infection in the body. CLL is the most common adult leukemia in the
Western world, with the median age at diagnosis being primarily those over 70
years old. The incidence rates among men and women in Europe are approximately
5.87 and 4.01 cases per 100,000 persons per year, respectively. CLL is a
chronic disease; median overall survival ranges between 18 months and more
than 10 years according to the stage of disease. When cancer cells are located
mostly in the lymph nodes, the disease is called small lymphocytic lymphoma
(SLL).^7,8,9,10,11,12

About Mantle Cell Lymphoma (MCL)

MCL is a rare and aggressive blood cancer that usually occurs in older adults,
with the median age at diagnosis being 65 years. The disease typically begins
in the bone marrow, but can spread to other tissues such as bone marrow, liver
and spleen. The incidence rates among men and women in Europe are
approximately 0.64 and 0.27 cases per 100,000 persons per year, respectively.
MCL patients generally have a poor prognosis. Median overall survival is
typically three to four years, and only one to two years in patients following
the first relapse. ^13,14,15,16

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, 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 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 tumor microenvironment.

Janssen and Pharmacyclics Strategic Partnership

Ibrutinib is being co-developed as part of a strategic partnership between
Janssen and Pharmacyclics, Inc. Both companies are responsible for the
development, manufacturing and commercialisation of ibrutinib. In Europe,
Janssen is the lead party for the commercialisation of ibrutinib, if approved.
Details about the complete ibrutinib clinical program are posted on
clinicaltrials.gov.

(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-Cilag
International NV, 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.)

                                    # # #

References

1. National Cancer Institute. Definition: B cell. Available from:
http://www.cancer.gov/dictionary?cdrid=45611. Accessed May 14, 2013.

2. Qiu Y, Kung HJ. Signaling network of the Btk family kinases. Oncogene
2000;19:5651-61.

3. Shaffer AL, Rosenwald A, Staudt LM. Lymphoid malignancies: the dark side of
B-cell differentiation. Nat Rev Immunol. 2002;2:920-32.

4. 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.

5. Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a
therapeutic target in CLL. Blood 2012;120:1175-84.

6. Akinleye A, Chen Y, Mukhi N, Song Y, Liu D. Ibrutinib and novel BTK
inhibitors in clinical development. J Hematol Oncol 2013;6:59.

7. Parker, T. Chronic lymphocytic leukemia: prognostic factors and impact on
treatment. Discovery Medicine. 2011; 57.

8. SEER Statistics. Fact Sheets: Chronic lymphocytic leukemia. Available from:
http://seer.cancer.gov/statfacts/html/clyl.html. Accessed March 6, 2013.

9. American Cancer Society. Detailed guide: what is chronic lymphocytic
leukemia. Available from:
http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll.
Accessed March 6, 2013.

10. Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic
malignancies in Europe by morphologic subtype: results of the HAEMACARE
project. Blood 2010;116:3724-34.

11. Cancer Research UK. The most common types of non-Hodgkins lymphoma.
Available from:
http://www.cancerresearchuk.org/cancerhelp/type/non-hodgkins-lymphoma/about/types/the-most-common-types-of-non-hodgkins-lymphoma#sll.
Accessed March 14, 2013.

12. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators in
chronic lymphocytic leukemia. Cancer Control 2012;19:18-25.

13. McKay P, Leach M, Jackson R, et al. Guidelines for the investigation and
management of mantle cell lymphoma. Br J Haematol 2012;159:405-26.

14. Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Available from:
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf.
Accessed May 14, 2013.

15. Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle cell lymphoma
and other non-Hodgkin lymphoma subtypes. Semin Cancer Biol 2011;21:293-8.

16. Goy A, Bernstein SH, Kahl BS, et al. Bortezomib in patients with relapsed
or refractory mantle cell lymphoma: updated time-to-event analyses of the
multicenter phase 2 PINNACLE study. Ann Oncol 2009;20:520-5.

Contact:

Janssen
Media Inquiries:
Satu Kaarina Glawe
Phone: +49 (0) 2638 947 9218
Mobile: +49 (172) 294 6264
Email: sglawe@its.jnj.com
Investor Relations:
Stan Panasewicz
Phone: +1 732-524-2524
Louise Mehrotra
Phone: +1 732-524-6491
 
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