Summary: The EMEA has confirmed the Marketing Authorization Application for
Arzerra is valid and that the review procedure has started.
Copenhagen, Denmark; February 26, 2009 - Genmab A/S (OMX: GEN) announced today
that the European Medicines Agency (EMEA) has confirmed the Marketing
Authorization Application (MAA) for Arzerra(TM) (ofatumumab) for the treatment
of chronic lymphocytic leukemia (CLL) is valid and that the review procedure
started on February 25, 2009. If approved, ofatumumab would be indicated for
the treatment of patients with CLL who have previously failed, or are
inappropriate for, standard therapies. The MAA was submitted on February 5,
2009.
The acceptance of the MAA will trigger a milestone payment from GlaxoSmithKline
to Genmab of DKK 58 million (approximately USD 10 million).
“We are excited to reach this important milestone so soon after submitting the
Arzerra(TM) MAA to the European regulatory authorities,” said Lisa N. Drakeman,
Ph.D., Chief Executive Officer of Genmab.
About ofatumumab
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. The CD20 molecule is a key target in CLL
therapy because it is expressed on most B-cells in CLL patients. In Europe,
ofatumumab has been granted orphan designation for CLL as it affects
approximately 3.5 in 10,000 persons in the European Union.
Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. It is not yet approved in any
country.
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.
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. For a
further discussion of these risks, please refer to the section “Risk Management”
in Genmab's Annual Report, which is available on www.genmab.com. Genmab does
not undertake any obligation to update or revise forward looking statements in
this press release nor to confirm such statements in relation to actual results,
unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM);
HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM); and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(TM) is a trademark of GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com
Stock Exchange Release no. 7/2009
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