Summary: An IND has Been Filed With the FDA for the Fourth Genmab Antibody
Developed Under the Company's Collaboration with Roche.
COPENHAGEN, December 12 /PRNewswire-FirstCall/ -- 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,
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.
|SOURCE Genmab A/S|
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