Summary: Recruitment of patients in the pivotal study of Arzerra in the
treatment of refractory CLL has been completed.
Copenhagen, Denmark; July 9, 2009 - Genmab A/S (OMX: GEN) announced today it has
completed recruitment of patients in the pivotal study of Arzerra™ (ofatumumab)
in the treatment of refractory chronic lymphocytic leukemia (CLL). A total of
220 patients have been enrolled in the study including 100 patients refractory
to fludarabine and alemtuzumab, 100 patients who are refractory to fludarabine
and considered inappropriate candidates for alemtuzumab and 20 patients who did
not qualify for either category.
Based on positive results from an interim analysis in this study, Genmab and
GlaxoSmithKline submitted a Biologics License Application (BLA) to the U.S. Food
and Drug Administration (FDA) in January and a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMEA) in February.
About the study
The study includes patients with CLL refractory to both fludarabine and
alemtuzumab, and patients who are refractory to fludarabine and considered
inappropriate candidates for alemtuzumab due to bulky tumor masses in their
lymph nodes. The study design calls for patients to receive eight weekly
infusions of ofatumumab, followed by four monthly infusions. Patients receive
300 mg of ofatumumab at the first infusion and 2,000 mg of ofatumumab at each
subsequent infusion. Disease status is assessed every four weeks until week 28
and then every three months until disease progression or month 24.
The primary endpoint of the study is objective response over a 24 week period
from start of treatment as assessed according to the National Cancer Institute
Working Group guidelines by an Independent endpoint Review Committee (IRC). The
secondary endpoints include duration of response, progression free survival,
time to next CLL therapy, overall survival and adverse events.
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.
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 Stock Exchange 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 Stock Exchange 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. 26/2009
###
