Genmab — Regulatory Filings 2013

May 1, 2013

News Details

Ad-hoc | 1 May 2013 17:42

Daratumumab Receives Breakthrough Therapy Designation from US Food and Drug Administration

Genmab A/S

01.05.2013 17:42

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Company Announcement

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

Copenhagen, Denmark; May 1, 2013 - Genmab A/S (OMX: 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, approximately 21,700
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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Language: English
Company: Genmab A/S

          Dänemark

Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:

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