Genmab — Earnings Release 2009

Jul 29, 2009

News Details

Ad-hoc | 29 July 2009 22:07

GlaxoSmithKline and Genmab Announce Top-Line Results for Ofatumumab in Rheumatoid Arthritis

Genmab A/S /

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Summary: GSK and Genmab announced preliminary top-line results from a Phase III
study of ofatumumab in RA.

London, UK and Copenhagen, Denmark; July 29, 2009 - GlaxoSmithKline (GSK) and
Genmab A/S (OMX: GEN) announced today preliminary top-line results from a Phase
III study of ofatumumab administered intravenously for the treatment of
rheumatoid arthritis (RA) in patients who had an inadequate response to
methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which
indicates a 20 percent or greater improvement in the number of swollen and
tender joints, as well as improvements in other disease-activity measures.

In the study, 260 patients were treated and included in the analysis. At week
24, the ACR20 response rate was significantly greater for RA patients on
ofatumumab (n=129) than on placebo (n=131) with a 50 percent response rate in
the patients receiving ofatumumab, compared to 27 percent for patients on
placebo (p-value less than 0.001). All key secondary endpoints were significant
(p-value less than or equal to 0.001).

There were no unexpected safety findings. The most common adverse events in the
ofatumumab treated patients (greater than 5 percent) were rash, urticaria,
nasopharyngitis, pruritus, throat irritation and hypersensitivity. Other than
nasopharyngitis, these events generally occurred within 24 hours of the first
infusion. One death, judged by the investigator as unrelated to ofatumumab, was
reported in the study during the 24-week study period.

'We have always believed in ofatumumab's potential to make a difference in
patients' lives. We are pleased with the results of this study, supporting the
further investigation of this antibody's promise in the treatment of RA,' said
Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

'RA can be a highly debilitating disease. It is encouraging to see the
reduction in disease symptoms achieved with intravenous ofatumumab, and we look
forward to presenting the full study results,' said Carlo Russo, M.D., Senior
Vice President, Biopharm Development, GSK.?

About the study
In this 24 week double-blind study, patients with active RA were randomized to
receive two 700 mg doses of intravenous ofatumumab or placebo two weeks apart in
addition to background methotrexate. Disease status was measured every 4 weeks.
Patients for this non-IND study were recruited from Europe, South America and
Australia.

The primary objective of the study was to determine the efficacy of intravenous
ofatumumab in reducing the clinical signs and symptoms in RA patients after two
700 mg doses of ofatumumab compared to placebo. The primary endpoint of the
study was ACR20 at 24 weeks. Other key secondary objectives included safety,
patient reported outcomes, biomarkers and ACR 50 and ACR 70.

ACR Response
The ACR 20 response is defined as a 20 percent or greater improvement from
baseline in tender and swollen joint counts, and 20percent or greater
improvement in 3 of the 5 following assessments: patient and physician global
assessments, pain, disability, and an acute phase reactant (ESR or CRP).

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 for other indications 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 Thursday,
July 30, 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:
+1 877-941-1883 (in the US) and quote conference ID number 4129982
+1 480-629-9702 (outside the US) and quote conference ID number 4129982

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

About GlaxoSmithKline (GSK)
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better, and live longer. For company
information, visit GlaxoSmithKline at www.gsk.com.

GSK's BioPharm R&D division has a rich early pipeline based on cutting edge
molecular biology and genetic technology and a mature late-stage portfolio that
will provide important medicines to oncology.

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.

GSK Enquiries
UK Media enquiries: Philip Thomson +44 20 8047 5502
David Outhwaite +44 20 8047 5502
Stephen Rea +44 20 8047 5502
US Media enquiries: Mary A. Rhyne +1 919 699 1758
European Analyst/Investor enquiries: David Mawdsley +44 20 8047 5564
Sally Ferguson +44 20 8047 5543
Gary Davies +44 20 8047 5503
US Analyst/Investor enquiries: Tom Curry +1 215 751 5419
Jen Hill Baxter +1 215 751 7002

Genmab Enquiries
Helle Husted, Vice President, Investor Relations T: +45 33 44 77 30
M: +45 25 27 47 13
E: h.husted@genmab.com

Cautionary statement regarding forward-looking statements for GSK:
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s Annual
Report on Form 20-F for 2007.

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Forward Looking Statement for Genmab
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. 29/2009

News Source: NASDAQ OMX

29.07.2009 Financial News transmitted by DGAP

Language: English
Issuer: Genmab A/S

          Denmark

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ISIN: DK0010272202
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