GSK and Genmab Announce Submission to US Regulatory Authorities for Arzerra(r)
(Ofatumumab) as 1st Line Treatment of Chronic Lymphocytic Leukemia (CLL)
*sBLA submitted to US FDA for Arzerra in 1st line CLL
*Follows recent EU application for expanded label of Arzerra
Copenhagen, Denmark; October 18, 2013 - GlaxoSmithKline (GSK) and Genmab A/S
(Copenhagen:GEN) announced today the submission of a supplemental Biologics
License Application (sBLA) to the US Food and Drug Administration (FDA) for
the use of Arzerra (ofatumumab) in combination with an alkylator-based
therapy, to be used for treatment of CLL patients who have not received prior
treatment and are inappropriate for fludarabine-based therapy.
The application is based on results from an international, multi-center,
randomized Phase III study of Arzerra in combination with chlorambucil versus
chlorambucil alone in more than 400 patients with previously untreated CLL.
Headline results from this trial were announced in May 2013 and the full study
results are scheduled to be presented in two oral presentations at the 2013
American Society of Hematology Annual Meeting in December.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. Based on estimates by the
American Cancer Society, CLL will account for more than 15,680 new cases and
more than 4,580 deaths in the United States of America alone in 2013.^1 At
present, no curative chemotherapy is available.
About Arzerra (ofatumumab)
Ofatumumab is not approved or licensed anywhere in the world for use in
patients who have not received treatment for CLL. For the approved
indication, please visithttp://us.gsk.com/html/medicines/index.htmlfor full
US Prescribing Information and http://health.gsk.com/for the EU Summary of
Product Characteristics (SPC).
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20
molecule encompassing parts of the small and large extracellular loops^2.
Ofatumumab is being developed under a co-development and collaboration
agreement between Genmab and GlaxoSmithKline.
One of the world's leading research-based pharmaceutical and healthcare
companies -- is committed to improving the quality of human life by enabling
people to do more, feel better, and live longer. For further information
please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company's first marketed
antibody, ofatumumab (Arzerra^(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future
product candidates. Partnering of innovative product candidates and
technologies is a key focus of Genmab's strategy and the company has alliances
with top tier pharmaceutical and biotechnology companies. For more
information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.com
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Forward Looking Statement for Genmab
This Company Announcement 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
pre-clinical and clinical development of products, 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 risk management sections in Genmab's most recent
financial reports, which are available on www.genmab.com . Genmab does not
undertake any obligation to update or revise forward looking statements in
this Company Announcement nor to confirm such statements in relation to actual
results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
Y-shaped Genmab logo^(r); Genmab in combination with the Y-shaped Genmab
logo^TM; the DuoBody(tm) logo; HuMax^(r); HuMax-CD20^(r); DuoBody^(r),
HexaBody^TM and UniBody^(r). Arzerra^(r) is a registered trademark of
Cautionary statement regarding forward-looking statements for GSK
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect GSK' s operations are described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
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^1American Cancer Society, Estimated Number of New Cancer Cases and Deaths by
Sex, US, 2013,
accessed September 18, 2013.
^2Teeling et al, J Immunol 2006; 177:362-371
Company Announcement no. 44
CVR no. 2102 3884
1260 Copenhagen K
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