Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration

Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug
Administration

Company Announcement

  *Daratumumab receives Breakthrough Therapy Designation in double refractory
    multiple myeloma
  *Potential for expedited development

COPENHAGEN, Denmark, May 1, 2013 (GLOBE NEWSWIRE) -- Genmab A/S
(Copenhagen:GEN) announced today that the US Food and Drug Administration
(FDA) has 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.
Breakthrough Therapy Designation is a program intended to expedite the
development and review of drugs to treat serious or life-threatening diseases
in cases where preliminary clinical evidence shows that the drug may provide
substantial improvements over available therapy. In August 2012, Genmab
granted Janssen Biotech, Inc. an exclusive worldwide license to develop and
commercialize daratumumab.

"Breakthrough designation allows us to work together with our strategic
partner Janssen and the FDA to expedite the development of daratumumab in
multiple myeloma, so patients suffering from this devastating type of blood
cancer could potentially receive access to this medicine much sooner," said
Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Breakthrough Therapy Designation

The Breakthrough therapy Designation was enacted as part of the 2012 FDA
Safety and Innovation Act (FDASIA) and is intended to expedite development of
drugs to treat serious and life-threatening medical conditions when
preliminary clinical evidence demonstrates that the drug may have substantial
improvement on at least one clinically significant endpoint over available
therapies. Breakthrough Therapy Designation includes all the features of the
Fast Track Designation, as well as more intensive guidance from the FDA on a
drug's clinical development program.

About daratumumab

Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing
activity. Daratumumab is in Phase I/II clinical development for multiple
myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed
on the surface of multiple myeloma cells. Daratumumab could also have
potential in other cancers on which CD38 is expressed, including diffuse large
B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia,
plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle
cell lymphoma.

About Multiple Myeloma

Multiple myeloma is a cancer of plasma cells and accounts for approximately 1%
of all cancers and is the most prevalent blood cancer in the US and second in
Europe. According to American Society of Cancer estimates,
approximately21,700 new cases of multiple myeloma will be diagnosed and
approximately 10,710 deaths will occur in the US in 2012. At present, no cure
is available. The 5-year relative survival rate for multiple myeloma is around
40%. New treatment modalities might improve the survival.

About Genmab A/S

Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company's first marketed
antibody, ofatumumab (Arzerra^(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future
product candidates. Partnering of innovative product candidates and
technologies is a key focus of Genmab's strategy and the company has alliances
with top tier pharmaceutical and biotechnology companies. For more
information visit www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

This Company Announcement contains forward looking statements. The words
"believe", "expect", "anticipate", "intend" and "plan" and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to
the outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment
in relation to our business area and markets, our inability to attract and
retain suitably qualified personnel, the unenforceability or lack of
protection of our patents and proprietary rights, our relationships with
affiliated entities, changes and developments in technology which may render
our products obsolete, and other factors. For a further discussion of these
risks, please refer to the risk management sections in Genmab's most recent
financial reports, which are available on www.genmab.com . Genmab does not
undertake any obligation to update or revise forward looking statements in
this Company Announcement nor to confirm such statements in relation to actual
results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
Y-shaped Genmab logo^(r); HuMax^(r); HuMax-CD20^(r); DuoBody^(r), HexaBody^TM
and UniBody^(r). Arzerra^(r) is a trademark of GlaxoSmithKline.


Company Announcement no. 18
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
 
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