Summary: First presentation of data from a Phase II study with ofatumumab
scheduled for the 2007 Annual European Congress of Rheumatology.
Copenhagen, Denmark; April 25, 2007 - Genmab A/S (CSE: GEN) announced today that
the results of a Phase II study with ofatumumab (HuMax-CD20 (TM)) in patients
with rheumatoid arthritis (RA) have been accepted for oral presentation at the
2007 Annual European Congress of Rheumatology (EULAR). The oral presentation,
which will include new results from the double-blind, placebo controlled Phase
II study with ofatumumab, along with data from the previous interim analysis,
will be described by Professor Mikkel Østergaard, Department of Rheumatology,
Copenhagen University Hospital on June 16, 2007. The abstract for the
presentation will be available at www.eular.org in mid-May.
Genmab A/S and GlaxoSmithKline have a worldwide agreement to co-develop and
commercialize ofatumumab.
About the study
A total of 226 patients with active RA who have previously failed one or more
disease-modifying anti-rheumatic drugs (DMARDs) were enrolled in the Phase II
study. Patients were randomized to one of 4 treatment groups (300 mg, 700 mg or
1000 mg of ofatumumab or placebo). Patients were permitted to continue therapy
with stable doses of methotrexate and low dose prednisolone. ACR and EULAR
responses were assessed in the primary intention-to-treat efficacy population at
24 weeks.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases. Genmab has
numerous products in development to treat cancer, infectious disease, rheumatoid
arthritis and other inflammatory conditions, and intends to continue assembling
a broad portfolio of new therapeutic products. In addition, Genmab has developed
UniBody(TM), a new proprietary technology that creates a stable, smaller
antibody format. Genmab has operations in Europe and the US. For more
information about Genmab, visit www.genmab.com.
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.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-EGFr(TM);
HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM), HuMax-CD38(TM);
HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Investor News No. 05/2007
New Data on Genmab and GlaxoSmithKline's Ofatumumab: Phase II Study in Rheumatoid Arthritis to be Presented at EULAR
| Source: Genmab A/S
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