Copenhagen, Denmark; November 20,
2007 – Genmab A/S (OMX: GEN) and GlaxoSmithKline (LSE and NYSE:
GSK) announced today the initiation of the Phase III program with
ofatumumab to treat rheumatoid arthritis (RA). The program will commence
with two studies (GEN410/OFA110635 and GEN411/OFA110634) which will be
conducted outside the US, in two distinct patient populations. One study
will be in patients who have had an inadequate response to methotrexate
therapy and the other in patients who had an inadequate response to
TNF-alpha antagonist therapy. Further studies to support the program
are planned for 2008.
Each study will evaluate the efficacy of ofatumumab in reducing the
clinical signs and symptoms in RA patients after a single course of
ofatumumab and are comprised of a 24 week double-blind period followed by a
120 week open-label period during which re-treatment will be studied. The
primary endpoint in each study is ACR20 at 24 weeks.
“This brings us closer to our goal of broadening the treatment options for
patients with this painful and debilitating disease,” said Lisa N.
Drakeman, Ph.D., Chief Executive Officer of Genmab. “From the data to date,
we believe that ofatumumab has real potential. Now that Phase 3
studies are underway in multiple indications, we are moving closer to
realizing this potential and bringing this important treatment to
patients.”
“We are very pleased that our collaboration with Genmab has progressed so
that we can now move to the next step of the clinical trial program,” said
Dr. Moncef Slaoui, Chairman of Research and Development, GlaxoSmithKline.
Ofatumumab is an investigational, fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 receptor on the surface
of B-cells. This epitope is different than other anti-CD20 antibodies
currently available or in development.
About the trials
GEN410/OFA110635 - Clinical efficacy and safety of ofatumumab in
adult RA patients who had an inadequate response to methotrexate
A total of approximately 250 patients who had an inadequate response to
methotrexate therapy will be enrolled. In the double-blind period, patients
will be randomized to receive two 700 mg doses of ofatumumab or placebo two
weeks apart in addition to background methotrexate. Rescue treatment with
nonbiologic disease modifying anti-rheumatic drugs (DMARDs) will be allowed
from week 16 in the double-blind period. All patients who
complete the double-blind period without receiving rescue treatment will
continue into the open-label period of the study. Re-treatment will
be studied starting at week 24. Disease status will be measured every
4 weeks during the double-blind period and every 8 weeks during the
open-label period.
GEN411/OFA110634 - Clinical efficacy and safety of ofatumumab in
adult RA patients who have had an inadequate response to TNF-alpha
antagonist therapy
A total of approximately 250 patients who had an inadequate response to
TNF-alpha antagonist therapy will be enrolled. In the double-blind period,
patients will be randomized to receive two 700 mg doses of ofatumumab or
placebo two weeks apart in addition to background methotrexate.
Rescue treatment with nonbiologic disease modifying anti-rheumatic drugs
(DMARDs) will be allowed from week 16 in the double-blind period. All
patients who complete the double-blind period without rescue treatment will
continue into the open-label period of the study. Re-treatment will be
studied starting at week 24. Disease status will be measured every 4
weeks during the double-blind period and every 8 weeks during the
open-label period.
About Genmab A/S
Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for unmet medical needs.
Using unique, cutting-edge antibody technology, Genmab’s world class
discovery and development teams have created and developed an extensive
pipeline of products for potential treatment of a variety of diseases
including cancer and autoimmune disorders. As Genmab advances towards
a commercial future, we remain committed to our primary goal of improving
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.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For more information, visit GlaxoSmithKline on the World Wide Web
at www.gsk.com.
Genmab forward looking statements
This press 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. Genmab is not under an obligation to up-date statements
regarding the future following the publication of this release; nor to
confirm such statements in relation to actual results, unless this is
required by law.
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GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, 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 the Group's operations are
described under 'Risk Factors' in the Business and Prospects in the
company’s Annual Report on Form 20-F for 2006.
Contact:
Genmab
Helle Husted, Sr. Director, Investor Relations
T: +45 33 44 77 30; M: +45 25 27 47 13; E: hth@genmab.com
GlaxoSmithKline
UK Media
Claire Brough
T: +44 20 8047 5505
US Media
Nancy Pekarek
T: +1 919 483 2839