Genmab Announces Start of Ofatumumab Phase III Head to Head Study in DLBCL

Mon Nov 9, 2009 2:40am EST
 
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COPENHAGEN, Denmark, Nov. 9, 2009 (GLOBE NEWSWIRE) -- Summary: Genmab has
initiated a Phase III study of Arzerra ofatumumab in diffuse large B-cell
lymphoma.

Genmab A/S (Copenhagen:GEN) announced today the initiation of a Phase III study
of Arzerra (TM) ofatumumab plus chemotherapy versus rituximab plus chemotherapy
to treat patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL).

"The start of this study marks an important milestone in the development of
ofatumumab. It is the first head to head study of ofatumumab against another
CD20 antibody," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

The study will include 380 patients who are refractory to or have relapsed
following first line treatment with rituximab in combination with a chemotherapy
regimen containing anthracycline and are eligible for autologous stem cell
transplant (ASCT). Patients in the study will be randomized to receive three
cycles of either ofatumumab or rituximab in addition to chemotherapy. After the
third treatment cycle patients who obtain a complete or partial response will
receive high dose chemotherapy followed by ASCT. The primary endpoint of the
study is progression free survival.

About ofatumumab

Ofatumumab is an investigational, fully human monoclonal antibody that binds
specifically to the small and large extracellular loops of the CD20 molecule
proximal to the cell membrane. The CD20 molecule is a key target in B-cell
malignancy therapy because it is expressed on most B-cells.

Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in
any country for DLBCL.

About Genmab A/S

Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.

This Stock Exchange Release 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 product discovery and development, 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
section "Risk Management" in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.

Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM);
HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(TM) is a trademark of GlaxoSmithKline.

Stock Exchange Release no. 43/2009

-0-
CONTACT:  Genmab A/S
          Helle Husted, Vice President, Investor Relations
          +45 33 44 77 30
          Cell: +45 25 27 47 13
          h.husted@genmab.com

 

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