Summary: Genmab announces that the FDA has placed a partial clinical hold on
zalutumumab clinical trials.
Copenhagen, Denmark; June 3, 2009 - Genmab A/S (OMX: GEN) announced today that
the US Food and Drug Administration (FDA) has placed a partial clinical hold on
zalutumumab clinical studies being conducted under the US Investigational New
Drug (IND) application, as well as requests for new studies. The affected
studies are the Phase II study in patients with head and neck cancer considered
incurable with standard treatment and the Phase I/II front line study of
zalutumumab in combination with chemo-radiation.
The partial clinical hold does not affect the two ongoing Phase III studies of
zalutumumab in head and neck cancer or the Phase I/II study of zalutumumab in
combination with radiotherapy as these are conducted outside the US IND.
Results from the pivotal Phase III study in refractory head and neck cancer, for
which 264 patients have been recruited to date, are still expected by the end of
2009.
A partial clinical hold is a delay or suspension of only part of the clinical
work requested under an IND. Under the partial clinical hold on zalutumumab,
patients already enrolled in the Phase II and Phase I/II studies who are not
experiencing serious adverse events may continue to receive treatment, however,
no additional patients may be enrolled.
The FDA has requested an updated analysis of safety data since the company's
most recent annual report which covered the period through July 29, 2008.
Genmab is working to respond to the request and expects to make the required
submission shortly.
“Genmab is fully committed to working with the FDA to meet their requests for
additional information and to resume enrollment in the affected zalutumumab
clinical trials as quickly as possible,” said Lisa N. Drakeman, Ph.D., Chief
Executive Officer of Genmab.
About zalutumumab
Zalutumumab is a high-affinity human antibody that targets the Epidermal Growth
Factor receptor (EGFr), a molecule found in abundance on the surface of many
cancer cells, and is a well validated target. Zalutumumab is in development to
treat head and neck cancer and has received a Fast Track designation from the
FDA covering patients with head and neck cancer who have previously failed
standard therapies.
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.
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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
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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. 19/2009
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