Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma

Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed
                      or Refractory Mantle Cell Lymphoma

PR Newswire

RARITAN, N.J., May 6, 2013

RARITAN, N.J., May 6, 2013 /PRNewswire/ --Janssen Research & Development, LLC
(Janssen) today announced patients are now enrolling in a multicenter,
open-label expanded access program (EAP) in the United States for the
investigational oral Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib, which
is being jointly developed by Janssen and Pharmacyclics, Inc. Several EAP
sites are in the process of opening the clinical trial and information about
the program is posted on clinicaltrials.gov (NCT01833039). The mantle cell
lymphoma (MCL) EAP is available to eligible patients with relapsed or
refractory MCL, who could benefit from treatment with ibrutinib prior to U.S.
Food and Drug Administration (FDA) approval.

Interested patients with MCL should discuss the option of accessing ibrutinib
through the EAP with their physician to understand if this is an appropriate
option for them.

"We recognize there are immediate medical needs of certain individuals with
relapsed or refractory MCL," said Peter F. Lebowitz, M.D., Ph.D., Global
Oncology Head, Janssen. "Now that the ongoing U.S. clinical studies in
relapsed or refractory MCL have completed enrollment, the expanded access
protocol provides that opportunity."

The ibrutinib expanded access program was agreed upon in collaboration with
the FDA as part of ibrutinib's breakthrough therapy designation for
relapsed/refractory MCL granted by the FDA in February 2013. EAPs are allowed
by the FDA under certain circumstances even though the safety and
effectiveness of the drug have not been fully established. Expanded access
programs provide a mechanism for early access to an investigational drug in
the pre-approval period to treat patients with a serious or immediately
life-threatening disease or condition that has no comparable or satisfactory
alternative treatment options.^^[1]

About the Ibrutinib Expanded Access Protocol
The ibrutinib mantle cell lymphoma (MCL) EAP is for patients who meet specific
eligibility criteria, which includes patients 18 years of age or older with
relapsed or refractory MCL who may benefit from treatment with ibrutinib prior
to FDA approval.  The EAP has specific inclusion and exclusion criteria which
must be met in order to be eligible for enrollment in the program. Patients
should contact their physician to discuss the option of accessing ibrutinib
through the EAP. Information about the expanded access treatment protocol is
posted on clinicaltrials.gov (NCT01833039).

About Mantle Cell Lymphoma
Mantle cell lymphoma is an aggressive type of B-cell non-Hodgkin lymphoma
(NHL) that usually occurs in older adults. The disease typically begins in the
lymph nodes, but can spread to other tissues, such as bone marrow and the
liver. Ibrutinib targets the B-cell receptor pathway, an important pathway in
malignant B-cell growth and proliferation. In the United States, there are
approximately 5,000 new cases of MCL each year.

About Ibrutinib
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor. The effectiveness and
safety of ibrutinib alone or in combination with other treatments is being
studied in several B-cell malignancies.

Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license
agreement in December 2011 to co-develop and co-commercialize ibrutinib. The
regulatory filing for ibrutinib in MCL is expected to be made prior to the end
of 2013.

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] The U.S. Food and Drug Administration. Access to Investigational Drugs
Outside of a Clinical Trial (Expanded Access). Available at:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm.

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SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com