Receives Orphan Drug Designation for Nodal T-cell Lymphoma
Summary: Genmab announced today it has amended the ongoing HuMax-CD4 pivotal
study to treat refractory CTCL and has received an orphan drug designation for
the treatment of nodal T-cell lymphoma.
Copenhagen, Denmark; October 11, 2007 - Genmab A/S (OMX: GEN) announced today it
has amended the design of the ongoing pivotal study of HuMax-CD4(R)
(zanolimumab) to treat refractory cutaneous T-cell lymphoma (CTCL) patients.
The study which previously only included patients with the Mycosis Fungoides
(MF) form of CTCL has been expanded to include patients with Sézary Syndrome as
well. Furthermore, due to higher response rates observed at the 14 mg/kg dose
level during the first part of the pivotal study, the 8 mg/kg dose level will
now be discontinued, with all patients to be treated with 14 mg/kg of HuMax-CD4
once a week for 12 weeks.
These study amendments have been agreed to by the FDA under the Special Protocol
Assessment agreement already in place.
In addition, HuMax-CD4 has received an orphan drug designation for the treatment
of refractory CTCL in Australia and for the treatment of refractory nodal T-cell
lymphoma in Europe. HuMax-CD4 previously received Fast Track Status from the
FDA and orphan drug status in the US and Europe for the treatment of refractory
CTCL.
“We believe expanding the HuMax-CD4 pivotal study to include a broader group of
CTCL patients will allow us to speed up patient enrollment, test at a more
effective dose level and potentially offer treatment for Sézary Syndrome
patients as well as MF patients,” said Lisa N. Drakeman, Ph.D., Chief Executive
Officer of Genmab. “The potential of HuMax-CD4 in treating T-cell lymphoma
patients with unmet medical needs continues to be recognized by the
international regulatory authorities.”
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.
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. 48/2007
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