Ibrutinib Data Published in The New England Journal of Medicine Show 68 Percent Overall Response Rate in Patients with

   Ibrutinib Data Published in The New England Journal of Medicine Show 68
Percent Overall Response Rate in Patients with Relapsed/Refractory Mantle Cell
                                Lymphoma (MCL)

A second study in relapsed/refractory chronic lymphocytic leukemia (CLL) also
published in the online edition

PR Newswire

RARITAN, N.J., June 19, 2013

RARITAN, N.J., June 19, 2013 /PRNewswire/ -- Janssen Research & Development,
LLC (Janssen) today announced that a study published online in The New England
Journal of Medicine (NEJM) demonstrates treatment with ibrutinib, an
investigational oral Bruton's tyrosine kinase (BTK) inhibitor, resulted in an
overall response rate of 68%, with 47% of patients achieving a partial
response and 21% achieving a complete response, or the disappearance of all
signs of cancer, in patients with relapsed/refractory mantle cell lymphoma
(MCL). The response to ibrutinib did not vary based on prior exposure to
bortezomib.

A separate study was published in the same online edition, examining the
safety and efficacy of ibrutinib for the treatment of relapsed/refractory
chronic lymphocytic leukemia (CLL). Ibrutinib is being jointly developed by
Janssen and Pharmacyclics, Inc. who also sponsored the studies.

"The safety and efficacy results of ibrutinib as observed in the mantle cell
lymphoma study have not been seen before with a single agent," said lead
author Michael Wang, M.D., Department of Lymphoma/Myeloma, The University of
Texas MD Anderson Cancer Center. "I am excited to see data demonstrating an
increasing response to ibrutinib without an associated increase in adverse
events over time."

The primary endpoint of the study was overall response rate. Secondary
endpoints included: duration of response, progression free survival, overall
survival and frequency and severity of adverse events.

Progression-free survival for patients in the study was 13.9 months and while
the median overall survival for this study has not been reached, it is
estimated to be 58% at 18 months. The estimated median duration of response
for those patients who responded (n=75) was 17.5 months. The overall-survival
analysis was performed at the time of the primary analysis of progression-free
survival, when 70% (63.1%) of patients were alive; the median overall survival
had not yet been reached.

The most common non-hematologic events regardless of causal relationship
(occurring in >30% of patients) being reported were diarrhea (50%), fatigue
(41%) and nausea (31%). Adverse hematologic events were relatively infrequent.
Eight patients experienced an adverse event (AE) leading to treatment
discontinuation. The most common non-hematologic Grade 3 or greater AE was
pneumonia (6%). Grade 3 or greater hematological toxicities were neutropenia
(16%), thrombocytopenia (11%) and anemia (10%) as the leading AEs.

This Phase 2 multicenter, open-label, study included 111 patients with
relapsed/refactory MCL treated with ibrutinib at 18 sites internationally and
was designed to determine the safety and efficacy of ibrutinib in patients
with relapsed/refractory MCL. Patients were enrolled into two cohorts based on
prior bortezomib exposure – either no prior bortezomib (n=63) or prior
bortezomib (n=48) – with both groups receiving 560 mg of ibrutinib orally,
once a day, and had received a median of three prior therapies.  The data were
presented in part at the annual meeting of the American Society of Hematology
in December 2012, the European Hematology Association annual meeting in June
2013 and are being presented at the 12th International Conference on Malignant
Lymphoma in Lugano, Switzerland this week.



                Bortezomib-naive Bortezomib-exposed All evaluated patients
                (n=63)           (n=48)             (n=111)
Complete
response,       12 (19)          11 (23)            23 (21)
n (%)
Partial         31 (49)          21 (44)            52 (47)
response, n (%)
Overall         43 (68)          32 (67)            75 (68)
response, n (%)

"The results of this study add to the growing body of evidence supporting the
safety and efficacy of ibrutinib in patients with MCL," said Peter Lebowitz,
M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen. "It's positive
news to have a compound like ibrutinib in development, especially as it
continues to show promise as a much needed option for patients with
relapsed/refractory MCL."

About Mantle Cell Lymphoma
MCL is a B-cell malignancy, an aggressive type of B-cell non-Hodgkin lymphoma
(NHL) that usually occurs in older adults.^1 The disease typically begins in
the lymph nodes, but can spread to other tissues, such as bone marrow and the
liver.^2 Ibrutinib targets the B-cell receptor pathway via inhibiting BTK, a
critical mediator in malignant B-cell growth and proliferation. In the United
States, there are approximately 5,000 new cases of MCL each year.^2

About Ibrutinib

Ibrutinib is an investigational, oral 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 the third quarter of 2013. Details about the complete ibrutinib clinical
program is posted on clinicaltrials.gov.

To date, ibrutinib has been granted three Breakthrough Therapy Designations by
the U.S. Food & Drug Administration (FDA) as a monotherapy for the treatment
of patients with CLL or small lymphocytic lymphoma (SLL) with deletion of the
short arm of chromosome 17 (del17p); patients with relapsed/refractory MCL who
have received prior therapy, and in patients with Waldenstrom's
macroglobulinemia (WM). The implications of Breakthrough Therapy Designation
cannot be determined at this time.

About Janssen Research & Development, LLC

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
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current expectations of future events. If underlying assumptions prove
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Development, LLC and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to, general industry conditions and competition; economic
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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
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Johnson undertake to update any forward-looking statements as a result of new
information or future events or developments.)

[1] Cancer.net. "Lymphoma – Non-Hodgkin".
http://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. Accessed
April 2013.

[2] Know Cancer. "Mantle Cell Lymphoma". Available at:
http://www.knowcancer.com/oncology/mantle-cell-lymphoma/. Accessed April 2013.

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SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com/
 
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