Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. Food and Drug

  Daratumumab Receives Breakthrough Therapy Designation in Double Refractory
           Multiple Myeloma from U.S. Food and Drug Administration

Second Janssen oncology compound to receive Breakthrough Therapy Designation

PR Newswire

RARITAN, N.J., May 1, 2013

RARITAN, N.J., May 1, 2013 /PRNewswire/ --Janssen Research & Development, LLC
(Janssen) announced the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy Designation for daratumumab for the treatment of patients
with multiple myeloma who have received at least three prior lines of therapy
including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or
who are double refractory to a PI and IMiD. Daratumumab is an investigational
human CD38 monoclonal antibody and was discovered by the Danish company Genmab
A/S. In August 2012, Janssen Biotech, Inc. and Genmab entered an agreement
which granted Janssen an exclusive worldwide license to develop and
commercialize daratumumab.

"We are honored that the FDA has granted Breakthrough Therapy Designation to
another compound in our pipeline," said Peter F. Lebowitz, M.D., Ph.D., Global
Oncology Therapeutic Area Head, Janssen. "Our team is looking forward to the
opportunity to work closely with the FDA on the development program of this
compound, which has the potential to make a difference in the lives of

This FDA designation marks the second oncology compound within the Janssen
pipeline to receive Breakthrough Therapy Designation in the last three months.
In April 2013 and February 2013, the company announced that the FDA granted
Breakthrough Therapy Designations for the investigational oral Bruton's
tyrosine kinase (BTK) inhibitor ibrutinib as a monotherapy for three B-cell
malignancies: in patients with chronic lymphocytic leukemia or small
lymphocytic lymphoma with deletion of the short arm of chromosome 17 (del17p),
in patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have
received prior therapy, and in patients with Waldenstrom's macroglobulinemia
(WM). Janssen and Pharmacyclics, Inc. are co-developing and will
co-commercialize ibrutinib.

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]

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

About Multiple Myeloma
Multiple myeloma is a cancer of plasma cells and according to the American
Cancer Society 2013 estimates, approximately 22,350 new cases of multiple
myeloma will be diagnosed and approximately 10,710 deaths will occur in the
U.S. in 2013.[2] At present, no cure is available. The 5-year relative
survival rate for multiple myeloma is around 40%.[3] New treatment modalities
might improve the survival.

About Daratumumab
Daratumumab is an investigational human monoclonal antibody (mAb) with broad
spectrum cytotoxic activity. It targets the CD38 molecule, which is highly
expressed on the surface of multiple myeloma cells and mayalso have potential
in other cancers on which CD38 is expressed. 

It is currently in Phase I/II trials for multiple myeloma and has potential
applicability against other malignancies on which CD38 is expressed.

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, Janssen Biotech, Inc., 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:

[2] How many people get multiple myeloma? The American Cancer Society.
Accessed March 2013.

[3] SEER Stat Fact Sheets: Myeloma. Surveillance Epidemiology and End Results,
National Cancer Institute. http://seer.cancer.gov/statfacts/html/mulmy.html.
Accessed March 2013.

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SOURCE Janssen Research & Development
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