Summary: An IND has been filed with the FDA for the fourth Genmab antibody
developed under the company's collaboration with Roche.
Copenhagen, Denmark; December 11, 2007 - Genmab A/S (OMX: GEN) announced today
that an Investigational New Drug application (IND) for a Genmab antibody
developed under the company's collaboration with Roche has been filed with the
FDA by Roche. Genentech and Roche are collaborating on development of the
antibody which selectively blocks the interaction of the OX40 ligand and its
receptor. The companies are evaluating the antibody for the treatment of
asthma. Genmab will receive a milestone payment from Roche which does not
influence Genmab's financial guidance for 2007.
In pre-clinical data published in a recent article and commentary in The Journal
of Clinical Investigation, treatment with the human OX40L blocking antibody led
to significant therapeutic effects in a nonhuman primate model of allergic
inflammation. The mechanisms of action of the human antibody include effective
blockade of OX40L binding to its receptor, and depletion of cells expressing
OX40L. Depletion of OX40L-expressing cells was shown to depend on interaction
of immune effector cells with the therapeutic antibody. The observed in vivo
efficacy of the OX40L-specific antibody may also involve restoration of
peripheral tolerance mechanisms. Breaking of tolerance promotes development of
autoimmune and allergic diseases.
Under the agreement with Roche, Genmab utilizes its broad antibody expertise and
development capabilities to create human antibodies to a broad range of disease
targets identified by Roche. Genmab receives milestone and royalty payments
based on successful products. In certain circumstances, Genmab may obtain rights
to develop products based on disease targets identified by Roche.
“Four of the antibodies developed by Genmab under our collaboration with Roche
have now entered the clinic. We believe this achievement is a testament to the
skill of Genmab's pre-clinical development team who work carefully to select the
best product candidates and Roche's dedicated focus on progressing them to
market,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
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-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
and UniBody(R) 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. 59/2007
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