DGAP-Adhoc

GSK and Genmab Announce Submission to US Regulatory Authorities for Arzerra(r) (Ofatumumab) as 1st Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Genmab A/S

18.10.2013 22:18

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Company Announcement

-- 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
(OMX: 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 visit http://us.gsk.com/html/medicines/index.html for 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 loops2.
Ofatumumab is being developed under a co-development and collaboration
agreement between Genmab and GlaxoSmithKline.

About 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