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Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
Date:5/6/2013

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 visit http://www.janssenrnd.com for 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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3. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
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