Genmab — Earnings Release 2009

Aug 11, 2009

News Details

Ad-hoc | 11 August 2009 21:21

Genmab Announces Preliminary Top-Line Results for Arzerra(TM) in Front Line CLL

Genmab A/S /

Release of a Adhoc News, transmitted by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

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Summary: Genmab announced top-line results from the Phase II study of Arzerra
in front line CLL.

Copenhagen, Denmark; August 11, 2009 - Genmab A/S (OMX: GEN) announced today
top-line results from the Phase II study of Arzerra(TM) (ofatumumab) in
combination with fludarabine and cyclophosphamide (FC) to treat chronic
lymphocytic leukemia (CLL) in previously untreated patients.

A total of 61 patients were treated in the study. Treatment response was
assessed using the 1996 National Cancer Institute Guidelines. The complete
remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and
50% in patients who received 1000 mg of ofatumumab (n=30). The overall response
rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment
group.

There were no unexpected safety findings reported during treatment and within 30
days after last infusion. The most common adverse event reported was neutropenia
at 48%. Other common adverse events (greater that 15 percent) were nausea,
leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number
of patients, who experienced adverse events, including serious adverse events,
was similar between the two dose groups. One death was reported and was judged
by the investigator as unrelated to ofatumumab.

'We are pleased to see the positive results of this first study investigating
ofatumumab for the treatment of front line CLL,' said Lisa N. Drakeman, Ph.D.,
Chief Executive Officer of Genmab. 'We look forward to presenting the full data
at a future medical meeting.'

About the study
Patients in this open label study were randomized into two treatment groups.
Each patient was to receive one infusion of 300 mg of ofatumumab in combination
with FC followed by 5 monthly infusions of either 500 or 1000 mg of ofatumumab
in combination with FC. Disease status was measured every 4 weeks until week 24
and every 3 months thereafter until disease progression or 24 months. Treatment
response was assessed according to the 1996 National Cancer Institute Working
Group guidelines by an Independent endpoints Review Committee. Patients not
having progressed on their disease at 24 months will be followed for disease
progression at 6 month intervals until 60 months.

The objective of the study was to determine the efficacy of ofatumumab in
combination with FC in previously untreated CLL patients. The primary endpoint
was complete remission rate from start of treatment until 3 months after last
infusion.

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. The CD20 molecule is a key target in CLL
therapy because it is expressed on most B-cells in CLL patients.

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

Conference Call
Genmab will hold a conference call to discuss the ofatumumab results August 12,
2009, at

3:00 pm CEST
2:00 pm BST
9:00 am EDT

The conference call will be held in English.

The dial in numbers are as follows:
+1 888-561-1799 (in the US) and provide conference ID number 4140340
+1 480-629-9869 (outside the US) and provide conference ID number 4140340

To listen to a live webcast of the call please visit www.genmab.com.

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. 30/2009

News Source: NASDAQ OMX

11.08.2009 Financial News transmitted by DGAP

Language: English
Issuer: Genmab A/S

          Denmark

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

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