Genmab — Earnings Release 2009

Aug 26, 2009

News Details

Ad-hoc | 26 August 2009 16:55

Genmab Announces Positive Top-Line Results for Arzerra TM in Front Line NHL

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 announces positive top-line results from the Phase II study of
Arzerra in combination with CHOP in front line follicular NHL.

Copenhagen, Denmark; August 26, 2009 - Genmab A/S (OMX: GEN) announced today
positive top-line results from the Phase II study of Arzerra TM (ofatumumab) in
combination with cyclophosphamide, doxorubicin, vincristine and prednisone
(CHOP) in patients with previously untreated follicular non-Hodgkin's lymphoma
(NHL).

A total of 58 patients were treated in the study. The overall response rate
(ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including
24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In
patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including
38% CR, and 17% CRu.

There were no unexpected safety findings reported during treatment and within
30 days after last infusion. The most common adverse events of grade 3 or 4
(greater than 10 percent) were leucopenia and neutropenia. No events of sepsis
or pneumonia were observed, and no deaths reported in the trial.

'We are pleased with the positive results shown in this study and believe they
are indicative of the potential of ofatumumab in the treatment of front line
follicular non-Hodgkin's lymphoma,' said Lisa N. Drakeman, Ph.D., Chief
Executive Officer of Genmab.

Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline.

About the study
Patients in this open label study were randomized into two dose groups of 29
patients each. Patients were to receive 300 mg of ofatumumab at the first
infusion, followed by 5 infusions of either 500 or 1000 mg of ofatumumab every
3 weeks in combination with 6 cycles of CHOP. Disease status is measured prior
to the fourth cycle, at three months following the last treatment and then
every three months until month 12, and every six months thereafter until 24
months or initiation of alternative treatment. Treatment response was assessed
according to the 1999 standardized response criteria for NHL by an Independent
endpoints Review Committee.

The objective of the study is to determine the efficacy of two dose regimens of
ofatumumab in combination with CHOP in previously untreated follicular NHL
patients. The primary endpoint in the study was objective response from start
of treatment until 3 months after last administration of ofatumumab.

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 not yet approved in any country.

Conference Call
Genmab will hold a conference call to discuss the ofatumumab results on August
27, 2009, at

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

The conference call will be held in English.

The dial in numbers are as follows:
+1 888 504 7953 (in the US) and provide conference ID number 4575355
+1 719 457 2639 (outside the US) and provide conference ID number 4575355

To listen to a live webcast of the call, 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?;
HuMax-IL8?; HuMax-TAC?; HuMax-HepC?; HuMax-CD38?; HuMax-CD32b?; HuMax-TF?;
HuMax-Her2?; HuMax-VEGF? and UniBody(r) are all trademarks of Genmab A/S.
Arzerra? 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

News Source: NASDAQ OMX

26.08.2009 Financial News transmitted by DGAP

Language: English
Issuer: Genmab A/S

          Denmark

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

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