IMBRUVICA™ (ibrutinib) Capsules Now Approved in the U.S. for Mantle Cell Lymphoma Patients Who Have Received at Least One

   IMBRUVICA™ (ibrutinib) Capsules Now Approved in the U.S. for Mantle Cell
        Lymphoma Patients Who Have Received at Least One Prior Therapy

Single-agent oral therapy is one of the first medications to be approved via
the U.S. Food and Drug Administration's Breakthrough Therapy Designation
Pathway

PR Newswire

HORSHAM, Pa., Nov. 13, 2013

HORSHAM, Pa., Nov. 13, 2013 /PRNewswire/ -- Janssen Biotech, Inc. ["Janssen"]
today announced the U.S. Food and Drug Administration (FDA) has approved
IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy.^1 This indication
is based on overall response rate (ORR). An improvement in survival or
disease-related symptoms has not been established.

To view the multimedia assets associated with this release, please click:
http://www.multivu.com/mnr/62689-imbruvica-fda-approval-janssen

IMBRUVICA is one of the first medications to receive FDA approval via the
Breakthrough Therapy Designation pathway. Its approval comes just more
thanfour months after the New Drug Application (NDA) submission was completed
in late June 2013. IMBRUVICA is being jointly developed and commercialized by
Janssen and Pharmacyclics, Inc.

"Mantle cell lymphoma is a rare, aggressive type of B-cell lymphoma,"said
Michael Wang, M.D., Department of Lymphoma/Myeloma, The University of Texas MD
Anderson Cancer Center and lead investigator for the pivotal registration
trial PCYC-1104. "With IMBRUVICA, we now have a once-daily oral therapy that
has been shown to affect the disease. I'm proud to have been involved in this
study."

MCL is an orphan disease. Orphan diseases are characterized by high unmet need
and small patient populations affecting fewer than 200,000 people.^2 In the
U.S., approximately 2,900 new cases of MCL are diagnosed each year^3 with a
median age at diagnosis of 65.^4 MCL typically involves the lymph nodes, but
can spread to other tissues, such as the bone marrow, liver, spleen and
gastrointestinal tract.^5 This challenging disease is associated with poor
prognoses.^5

"The approval of IMBRUVICA is great news for MCL patients who have received
prior therapy and the physicians who treat them," said William Hait, M.D.,
Ph.D. global head, research and development, Janssen Research & Development,
LLC. "The Breakthrough Therapy Designation helped turbo-charge our timelines –
it's a remarkable process. It's an excellent example of collaboration between
the FDA, Janssen and Pharmacyclics."

"Breakthrough Therapy Designation is intended to speed up the development and
review of treatments to help address serious or life-threatening diseases. It
is gratifying to see this early example of the new Breakthrough Therapy
Designation pathway meeting its intention – getting promising treatments to
patients who are waiting for new options," said Dr. Ellen Sigal, chair and
founder of Friends of Cancer Research, a think tank and advocacy organization
based in Washington, DC.^**

IMBRUVICA was granted three Breakthrough Therapy Designations by the FDA,
including relapsed or refractory MCL. IMBRUVICA was approved under the FDA's
Subpart H regulation.^6 Janssen and Pharmacyclics are continuing an extensive
clinical development program for IMBRUVICA, including Phase 3 study
commitments in this patient population. Additionally, IMBRUVICA has been
submitted to the FDA for the treatment of previously treated patients with
chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase
(BTK).^1 Non-clinical studies have shown that blocking BTK inhibits malignant
B-cell survival.^1

The safety and efficacy of IMBRUVICA in patients with MCL who have received at
least one prior therapy were evaluated in an open-label, multi-center,
single-arm Phase 2 study of 111 treated patients. The primary endpoint was
investigator-assessed overall response rate (ORR). Based on investigator
assessment, the ORR was 65.8 percent (95% CI 56.2, 74.5%) and the median
duration of response was 17.5 months (95% CI 15.8, not reached).^1 This
endpoint was based on responses assessed according to the revised
International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.^1

The Warnings and Precautions for IMBRUVICA include hemorrhage, infections,
myelosuppression, renal toxicity, second primary malignancies and embryo-fetal
toxicity.

The most commonly occurring side effects (adverse reactions in 20 percent or
more of patients in the clinical trial) were thrombocytopenia*, diarrhea
(51%), neutropenia*, anemia*, fatigue (41%), musculoskeletal pain (37%),
peripheral edema (swelling of hands and feet, 35%), upper respiratory tract
infection (34%), nausea (31%), bruising (30%), dyspnea (shortness of breath,
27%), constipation (25%), rash (25%), abdominal (stomach) pain (24%), vomiting
(23%) and decreased appetite (21%). [*NOTE: Treatment-emergent decreases (all
grades) of platelets (57%), neutrophils (47%) and hemoglobin (41%) were based
on laboratory measurements and adverse reactions.]

The most common Grade 3 or 4 non-hematological adverse reactions (greater than
or equal to5%) were: pneumonia (7%), abdominal pain (5%), atrial
fibrillation, diarrhea (5%), fatigue (5%), and skin infections (5%).
Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients.
Ten patients (9%) discontinued treatment due to adverse reactions in the trial
(N=111).

The most frequent adverse reaction leading to treatment discontinuation was
subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred
in 14% of patients.

The recommended dose of IMBRUVICA is 560 mg (four 140 mg capsules) once
daily.^1

The IMBRUVICA MCL study was published online in The New England Journal of
Medicine in June 2013.^7

Access to IMBRUVICA
IMBRUVICA is commercially available immediately. Janssen Biotech is striving
to make the process of obtaining IMBRUVICA and navigating insurance benefits
easy for patients by offering comprehensive access services and support for
eligible patients. The YOU&i Access™ program is designed specifically for
patients who are prescribed IMBRUVICA and provides personalized attention
coupled with access services designed to make obtaining medication simple and
convenient for patients and those involved in their care.

This includes a YOU&i Access™ Instant Savings program, which provides co-pay
support and benefits information to eligible commercially-insured patients.
Patients can access the program by contacting 1-877-877-3536, option 1 or by
visiting www.IMBRUVICA.com.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage – Five percent (5%) of patients with MCL had Grade 3 or higher
bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria).
Bleeding events including bruising of any grade occurred in 48% of patients
with MCL treated with 560 mg daily. The mechanism for the bleeding events is
not well understood. Consider the benefit-risk of ibrutinib in patients
requiring antiplatelet or anticoagulant therapies and the benefit-risk of
withholding ibrutinib for at least 3 to 7 days pre and post-surgery depending
upon the type of surgery and the risk of bleeding.

Infections – Fatal and non-fatal infections have occurred. At least 25% of
patients with MCL had infectionsgreater than or equal toGrade 3, according
to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor
patients for fever and infections and evaluate promptly.

Myelosuppression – Treatment-emergent Grade 3 or 4 cytopenias were reported in
41% of patients. These included neutropenia (29%), thrombocytopenia (17%) and
anemia (9%). Monitor complete blood counts monthly.

Renal Toxicity – Fatal and serious cases of renal failure have occurred.
Treatment-emergent increases in creatinine levels up to 1.5 times the upper
limit of normal occurred in 67% of patients and from 1.5 to 3 times the upper
limit of normal in 9% of patients. Periodically monitor creatinine levels.
Maintain hydration.

Second Primary Malignancies – Other malignancies (5%) have occurred in
patients with MCL who have been treated with IMBRUVICA, including skin cancers
(4%), and other carcinomas (1%).

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause
fetal harm when administered to a pregnant woman. Advise women to avoid
becoming pregnant while taking IMBRUVICA. If this drug is used during
pregnancy or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to a fetus.

Adverse Reactions – The most commonly occurring adverse reactions (greater
than or equal to20%) in the clinical trial were thrombocytopenia*, diarrhea
(51%), neutropenia*, anemia*, fatigue (41%), musculoskeletal pain (37%),
peripheral edema (35%), upper respiratory tract infection (34%), nausea (31%),
bruising (30%), dyspnea (27%), constipation (25%), rash (25%), abdominal pain
(24%), vomiting (23%) and decreased appetite (21%).

* Treatment-emergent decreases (all grades) of platelets (57%), neutrophils
(47%) and hemoglobin (41%) were based on laboratory measurements and adverse
reactions.

The most common Grade 3 or 4 non-hematological adverse reactions (greater than
or equal to 5%) were: pneumonia (7%), abdominal pain (5%), atrial
fibrillation, diarrhea (5%), fatigue (5%), and skin infections (5%).
Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients.

Ten patients (9%) discontinued treatment due to adverse reactions in the trial
(N=111).

The most frequent adverse reaction leading to treatment discontinuation was
subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred
in 14% of patients.

Drug Interactions:
CYP3A Inhibitors – Avoid concomitant administration with strong or moderate
inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the
IMBRUVICA dose.

CYP3A Inducers – Avoid co-administration with strong CYP3A inducers.

Special Populations – Hepatic Impairment – Avoid use in patients with baseline
hepatic impairment.

For the full prescribing information, visit
http://www.imbruvica.com/downloads/Prescribing_Information.pdf.

About IMBRUVICA
IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma
(MCL) who have received at least one prior therapy.^1 This indication is based
on overall response rate (ORR). An improvement in survival or disease-related
symptoms has not been established.^1

IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase
(BTK).^1 BTK is a signaling molecule of the B-cell antigen receptor (BCR)
pathway, which is emerging as a target in some B-cell malignancies.^8,9,10
BTK's role in signaling through the B-cell surface receptors results in
activation of pathways necessary for B cell trafficking, chemotaxis and
adhesion.^1

For more information, visit www.IMBRUVICA.com.

About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology,
urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen
Biotech has delivered on the promise of new treatments and ways to improve the
health of individuals with serious disease. Beyond its innovative medicines,
Janssen Biotech is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates and
health care professionals have access to the latest treatment information,
support services and quality care. For more information on Janssen Biotech,
Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson &
Johnson, which are dedicated to addressing and solving some of the most
important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we work together to bring innovative
ideas, products, services and solutions to people throughout the world. Follow
us on Twitter at www.twitter.com/JanssenUS.

^**Janssen and Johnson & Johnson have provided funding to Friends of Cancer
Research for educational and support initiatives benefiting cancer patients
and their families.

Media Inquiries:
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Phone: 1-908-218-7316
Mobile: 1-908-670-0363

Kellie McLaughlin
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Investor Relations:
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Phone: 1-732-524-2524

Louise Mehrotra
Phone: 1-732-524-6491

Medical Information:
Pharmacyclics Medical
Information: 1-877-877-3536

^1 IMBRUVICA Prescribing Information, November 2013
^2 National Organization for Rare Disorders. "Rare Disease Information". Available from:
http://www.rarediseases.org/rare-disease-information/rare-disease-information. Accessed September 2013.
^3 © 2013 DR/ Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is
prohibited. Reprinted with permission.
^4 Humala K,Younes A. Current and emerging new treatment strategies for mantle cell lymphoma. Leukemia & Lymphoma.
2013; 54(5): 912–921.
^5 Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Available from:
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf.
Accessed August 2013.
^6 The U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21. Available from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.8.
Accessed August 2013.
^7 Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N
Engl J Med 2013 Jun 19 [epub ahead of print].
^8 Buggy JJ and Elias L. Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol.
2012;31:119-132.
^9 Woyach JA, Johnson AJ, and Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood.
2012;120(6):1175-1184
^10 Davis RE, Ngo VN, Lenz G, et al. Chronic active B-cell receptor signaling in diffuse large B-cell lymphoma.
Nature. 2010;463(7277):88-92

SOURCE Janssen Biotech, Inc.

Website: http://www.janssenbiotech.com