Summary: Genmab and GSK have announced the initiation of the Phase III program
with ofatumumab to treat rheumatoid arthritis.
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
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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
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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
Stock Exchange Release no. 53/2007
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Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
| Quelle: Genmab A/S