Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S. Food and Drug Administration

 Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S.
                         Food and Drug Administration

Designation granted in the treatment of patients with chronic lymphocytic
leukemia or small lymphocytic lymphoma with a genetic mutation, del17p

Ibrutinib is an investigational oral Bruton's tyrosine kinase inhibitor being
studied in several B-cell malignancies

PR Newswire

RARITAN, N.J., April 8, 2013

RARITAN, N.J., April 8, 2013 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA)
has granted a third Breakthrough Therapy Designation for the investigational
oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib. Ibrutinib has been
granted Breakthrough Therapy Designation as a monotherapy in the treatment of
patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with
deletion of the short arm of chromosome 17 (del17p). Del17p is a genetic
mutation that occurs in some patients with CLL/SLL; it is associated with a
poor prognosis. Ibrutinib is jointly being developed by Janssen and
Pharmacyclics Inc.

"Ibrutinib continues to demonstrate promise for patients living with B-cell
malignancies, and we are pleased that the FDA has recognized its potential for
people living with CLL and the del17p mutation," said Peter F. Lebowitz, M.D.,
Ph.D., Global Oncology Therapeutic Area Head, Janssen. "This third
Breakthrough Therapy Designation reflects the potential importance of
ibrutinib for patients diagnosed with a 17p deletion chromosomal abnormality
in CLL/SLL, and we are committed to working with Pharmacyclics and the FDA to
expedite development and review of ibrutinib as quickly as possible."

The implications of Breakthrough Therapy Designation cannot be determined at
this time. Janssen and Pharmacyclics are working with the FDA to determine any
potential implications of the Breakthrough Therapy Designation to the ongoing
and planned development activities.

In February 2013, FDA granted Breakthrough Therapy Designations for ibrutinib
as a monotherapy for two B-cell malignancies: in patients with relapsed or
refractory Mantle cell lymphoma (MCL) who have received prior therapy, and in
patients with Waldenstrom's macroglobulinemia (WM). Enacted as part of the
2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy Designation
is intended to expedite the development and review time for a potential new
medicine "to treat a serious or life-threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed early in
clinical development."[1]

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia (CLL) is a slow-growing cancer of the white blood
cells (lymphocytes), most commonly B-cells. CLL is the most common adult
leukemia.[2] The genetic mutation 17p occurs when part of chromosome 17 has
been lost. CLL patients with 17p deletion have poor treatment outcomes.[3] 17p
deletion is reported in seven percent of CLL cases at diagnosis,[4] with
approximately 20 to 40% of relapsed or refractory patients harboring the
mutation.[5] Small Lymphocytic Lymphoma (SLL) is a slow-growing lymphoma in
which too many immature white blood cells cause lymph nodes to become larger
than normal.[6]

About Ibrutinib
Ibrutinib was designed to specifically target and selectively inhibit an
enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at
least three critical B-cell pro-survival mechanisms occurring in parallel –
regulating apoptosis, adhesion, and cell migration and homing. Through these
multiple actions, BTK helps to direct malignant B-cells to lymphoid tissues,
thus allowing access to a microenvironment necessary for survival.

The effectiveness and safety of ibrutinib alone or in combination with other
treatments is being studied in several B-cell malignancies, including chronic
lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse
large B-cell lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia
and multiple myeloma. To date, five Phase III trials have been initiated with
ibrutinib and a total of 30 trials are currently registered on
clinicaltrials.gov.

Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license
agreement in December 2011 to co-develop and co-commercialize ibrutinib.

About Janssen Research & Development
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, 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 Research & Development and Janssen Biotech are
part of the Janssen Pharmaceutical Companies. Please
visithttp://www.janssenrnd.comfor 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 Research &
Development, LLC, 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.)

[1] PUBLIC LAW 112–144—JULY 9, 2012. U.S. Government Printing Office.
Available at:
http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.

[2] How Common is CLL? Leukemia & Lymphoma Society.
http://www.lls.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/incidence/.
Accessed March 2013.

[3]Non-Hodgkin's Lymphomas. Version 1.2013. NCCN Clinical Practice Guidelines
in Oncology. http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.
Accessed March 2013.

[4]Non-Hodgkin's Lymphomas. Version 1.2013. NCCN Clinical Practice Guidelines
in Oncology. http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.
Accessed March 2013.

[5] Stilgenbaueer S and Zenz T. Understanding and Managing Ultra High-Risk
Chronic Lymphocytic Leukemia. Hematology. 2010: 481-488.

[6] Small Lymphocytic Lymphoma. National Cancer Institute.
http://www.cancer.gov/dictionary?cdrid=407751. Accessed March 2013.

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SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
 
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