29/07/2009 21:07:10

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

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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


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.

Registered in England and Wales

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex


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


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