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GSK and Genmab Announce Positive Top-line Results from Pivotal Study of ARZERRA(r) (ofatumumab) Combined with Chlorambucil in Previously Untreated Chronic Lymphocytic Leukemia

Genmab A/S

29.05.2013 19:05

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Company Announcement

-- Median 22.4 month progression free survival in patients treated with
ofatumumab plus chlorambucil, an improvement of 9.3 months compared to
chlorambucil alone
-- No unexpected safety findings

Copenhagen, Denmark and London UK; May 29, 2013 - Genmab A/S (OMX: GEN) and
GlaxoSmithKline plc (GSK) announced today that their Phase III study of
ARZERRA(r) (ofatumumab) in combination with chlorambucil versus chlorambucil
alone in patients with previously untreated chronic lymphocytic leukemia (CLL)
met its primary endpoint of progression free survival (PFS) as assessed by an
Independent Review Committee (IRC).

A total of 447 patients were enrolled in the study. A 9.3 month improvement in
the time a patient lived without worsening of their disease (median PFS) was
seen in patients randomized to ofatumumab and chlorambucil compared to patients
randomized to chlorambucil alone (22.4 months vs. 13.1 months; Hazard Ratio
0.57; p<0.001).

There were no unexpected safety findings. The most common (>=1%) serious
adverse events as reported by the investigator within 60 days of last treatment
were neutropenia [including febrile neutropenia] (5%), anaemia (4%), pneumonia
(4%), and pyrexia (2%). Infusion reactions were mild to moderate in severity
with 3% of infusion reactions reported as serious.

'We are delighted with the positive results from this trial which we believe
may lead to ofatumumab plus chlorambucil as an additional treatment option for
the care of patients with CLL,' said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. 'We look forward to submitting the study results, including
secondary endpoints, to the International Workshop on CLL (iwCLL) in Cologne,
Germany this September.'

'As the aim of treating CLL, particularly in the frontline setting, is to
maximize progression free survival while minimizing side effects, we are
therefore encouraged by these promising results,' said Dr. Kathy Rouan, Vice
President BioPharmaceutical Development, GlaxoSmithKline. 'We are planning
regulatory submissions in the EU, US, and other regions in the coming months.'

About the study
This Phase III study (NCT00748189) included patients with previously untreated
CLL considered inappropriate for fludarabine-based therapy. Patients in the
study were randomized 1:1 to treatment with up to twelve cycles of ofatumumab
in combination with chlorambucil or up to twelve cycles of chlorambucil alone.
The primary endpoint of the study was PFS according to the International
Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated 2008 National Cancer
Institute-sponsored Working Group (NCIWG) guidelines, using an independent
endpoints review committee.

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. 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 Full US Prescribing
Information, please visit: http://us.gsk.com/html/medicines/index.htmland visit
http://health.gsk.com/ for the EU SPC for the approved indication.

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 GSK
GSK is 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.

GSK Contact:

UK Media enquiries:
David Mawdsley [phone] (London)
David Daley [phone] (London)
Catherine Hartley [phone] (London)

US Media enquiries:
Bernadette King [phone] (Philadelphia)
Anna Padula [phone] (Philadelphia)
Melinda Stubbee [phone] (North Carolina)
Karen Collins [phone] (North Carolina)
Stephen Rea [phone] (Philadelphia)

Analyst/Investor enquiries:
Ziba Shamsi [phone] (London)
Lucy Budd [phone] (London)
Tom Curry [phone] (Philadelphia)
Gary Davies [phone] (London)
James Dodwell [phone] (London)
Jeff McLaughlin [phone] (Philadelphia)

Genmab Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: [phone]; M: [phone]; E: [e-mail]

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.

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); HuMax(r); HuMax-CD20(r); DuoBody(r), HexaBody(TM) and
UniBody(r). Arzerra(r) is a trademark of GlaxoSmithKline.

Company Announcement no. 24
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

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Language: English
Company: Genmab A/S


Denmark
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ISIN: DK0010272202
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