Genmab — Regulatory Filings 2014

Aug 11, 2014

Company Announcement

-- Second Phase III study of daratumumab in front line multiple myeloma
-- Study expected to start in the first half of 2015

Copenhagen, Denmark; August 11, 2014 – Genmab A/S (OMX: GEN) announced today
that its collaboration partner, Janssen Biotech, Inc. (“Janssen”) plans to
start a new Phase III study of daratumumab in multiple myeloma. The study
(MMY3008) will compare daratumumab in combination with lenalidomide and
dexamethasone to lenalidomide and dexamethasone alone as front line treatment
for patients who are not considered candidates for stem cell transplantation
(SCT). The study is planned to start in the first half of 2015. The first Phase
III study in front line multiple myeloma was announced in July and is expected
to start towards the end of this year. Today’s news is the fourth daratumumab
Phase III study to be announced.

“This new study of daratumumab in front line multiple myeloma is part of the
extensive development plan created under our collaboration with Janssen Biotech
for our CD38 antibody daratumumab,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.

About the MMY3008 study
This Phase III study is a randomized, open-label, multicenter study and will
include approximately 700 newly diagnosed, chemotherapy naïve multiple myeloma
patients ineligible for stem cell transplantation (SCT). Patients will be
randomized to receive either daratumumab combined with lenalidomide (an
immunomodulatory agent) and dexamethasone (a corticosteroid) or lenalidomide
and dexamethasone alone. The primary endpoint of the study is progression free
survival (PFS).

About daratumumab
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing
activity. Daratumumab is in clinical development for multiple myeloma (MM).
Daratumumab targets the CD38 molecule which is highly expressed on the surface
of multiple myeloma cells. Daratumumab may 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. Daratumumab
has been granted Breakthrough Therapy Designation from the US FDA. In August
2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to
develop and commercialize daratumumab.

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 currently has one
marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications, a clinical pipeline with both late and early
stage programs, and an innovative pre-clinical pipeline. Genmab's technology
base consists of validated and proprietary next generation antibody
technologies - the DuoBody® platform for generation of bispecific antibodies,
and the HexaBody™ platform which creates effector function enhanced antibodies.
Genmab's deep antibody expertise is expected to provide a stream of future
product candidates. Partnering of selected 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®; the
Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™;
the DuoBody logo™; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody™
and UniBody®. Arzerra® is a registered trademark of the GSK group of companies.

Company Announcement no. 39
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark