Summary: Genmab announces that further development plans for ofatumumab in
oncology and autoimmune disease will be described today at GlaxoSmithKline's
Oncology Seminar.
Copenhagen, Denmark; June 18, 2007 - Genmab A/S (CSE: GEN) announced that
development plans for ofatumumab (HuMax-CD20(R)) will be described at
GlaxoSmithKline's (GSK) Oncology Seminar today. Ofatumumab is currently in late
stage development for chronic lymphocytic leukemia (CLL), follicular
non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA) and
is being developed under a worldwide co-development and commercialization
agreement between Genmab and GSK.
A clear demonstration of the efficacy and safety of ofatumuamb in two late stage
single-arm trials (CLL and follicular NHL), which are not routinely accepted as
registration studies, could provide the initial regulatory applications. Genmab
has received a Fast Track designation for the CLL study. Under these
circumstances, ofatumumab could potentially enter the market in 2008 first for
the treatment of refractory CLL and subsequently for rituximab-refractory
follicular NHL. We furthermore expect to expand the ofatumumab program into new
indications with the planned initiation of clinical studies in diffuse large
B-cell lymphoma (DLBCL) by the end of 2007 and randomized Phase III studies in
CLL and follicular NHL in the first half of 2008.
In the autoimmune disease setting, we expect to initiate Phase III studies of
ofatumumab in RA by the end of 2007. We also plan to expand the development
program with initiation of a Phase II study in relapsing remitting multiple
sclerosis (RRMS) in the first quarter of 2008. There is potential to pursue
indications in a wide range of autoimmune disease settings.
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-CD20(R);
HuMax-EGFr(TM); HuMax-Inflam(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
Stock Exchange Release no. 28/2007
