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.
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).
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.
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.
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Stock Exchange Release no. 29/2009