Arzerra Receives Approval in Japan
*Arzerra(r) approved in Japan for relapsed / refractory CLL
*Genmab to receive DKK 20 million milestone payment from GSK
COPENHAGEN, Denmark, March 25, 2013 (GLOBE NEWSWIRE) -- Genmab A/S
(Copenhagen:GEN) and GlaxoSmithKline (GSK) announced today the approval of
Arzerra (ofatumumab) by the Japanese Ministry of Health, Labor and Welfare
(MHLW) for use in patients with relapsed / refractory CD20-positive chronic
lymphocytic leukemia (CLL).The approval triggers a milestone payment of DKK
20 million from GSK to Genmab.
"We are pleased that patients in Japan will now have access to Arzerra. Japan
is another important market for Arzerra and commercialization continues on
track," said Jan van de Winkel, Ph.D. Chief Executive Officer of Genmab.
This milestone payment is included in Genmab's 2013 financial guidance.
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20
molecule encompassing parts of the small and large extracellular loops
(Teeling et al 2006). Ofatumumab is being developed under a co-development and
commercialization agreement between Genmab and GlaxoSmithKline.
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: firstname.lastname@example.org
This Company Announcement contains forward looking statements. The words
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identify forward looking statements. Actual results or performance may differ
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the outcome and conduct of clinical trials including unforeseen safety issues,
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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
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results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
Y-shaped Genmab logo^(r); HuMax^(r); HuMax-CD20^(r); DuoBody^(r), HexaBody^TM
and UniBody^(r). Arzerra^(r) is a trademark of GlaxoSmithKline.
Company Announcement no. 10
CVR no. 2102 3884
1260 Copenhagen K
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