Recruitment Completed in Arzerra™ (ofatumumab) Phase II Study in Relapsed DLBCL


Summary:  Recruitment of patients in the Phase II study of Arzerra (ofatumumab)
in relapsed DLBCL has been completed. 

Copenhagen, Denmark; July 24, 2009 - Genmab A/S (OMX: GEN) announced today it
has completed recruitment of 75 patients in the Phase II study of Arzerra(TM)
(ofatumumab) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma
(DLBCL) in patients ineligible for or relapsed following a stem cell
transplant. 

About the study
In this open label trial, each patient will receive 8 weekly infusions of
ofatumumab.  The first infusion will be 300 mg and the 7 subsequent infusions
will be 1000 mg of ofatumumab.  Disease status will be assessed 4 weeks after
the last infusion and then every 3 months for a total of up to 24 months after
treatment start. After 24 months, patients will be followed until initiation of
alternative DLBCL treatment or month 60. 

The objective of the study is to determine the efficacy of ofatumumab in
patients with relapsed DLBCL ineligible for transplant or relapsed after
transplant.  The primary endpoint of the study is objective response over a 6
month period from start of treatment. 

About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that
targets a membrane-proximal (close to the cell surface) small loop epitope (a
portion of a molecule to which an antibody binds) on the CD20 molecule of
B-cells.  This epitope is different from the binding sites targeted by other
CD20 antibodies currently available. 

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

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. 

Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com 
 
Stock Exchange Release no. 28/2009

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28 arzerra dlbcl recruitment_240709_uk.pdf
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