Summary: Genmab provides an update on the potential regulatory pathway for
zalutumumab.
- Genmab has received preliminary feedback from selected national European
regulatory authorities and FDA on zalutumumab
- Genmab believes a MAA for zalutumumab in second line head and neck cancer
could be pursued based on available clinical data
- Additional clinical study data would be required prior to a US regulatory
submission
Copenhagen, Denmark; October 18, 2010 - Genmab A/S (OMX: GEN) announced today an
update on the potential regulatory pathway for zalutumumab following
preliminary, non-binding discussions with a number of selected national European
regulatory authorities and the FDA. Based on overall feedback from regulatory
authorities in Europe, Genmab believes a Marketing Authorization Application
(MAA) for zalutumumab could be pursued based on the data from the Phase III
study in patients with recurrent or metastatic squamous cell carcinoma of the
head and neck (SCCHN) who failed standard platinum-based therapy, reported
earlier this year. Additional clinical study data would, however, be required
prior to submitting a regulatory application in the US.
“Our discussions with the regulatory authorities have been very productive and
we are encouraged by the overall feedback we have received,” said Prof. Jan van
de Winkel, Ph.D., Chief Executive Officer of Genmab. “We are advancing our
partnership discussions in earnest and feel confident that our potential future
development partner would be able to move forward with a European regulatory
filing for zalutumumab.”
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 and development 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-TF(TM);
HuMax-Her2(TM); HuMax-Wnt(TM); HuMax-cMet(TM) and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(R) 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. 40/2010
###
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