Genmab Announces Ofatumumab Development Plans in RRMS and NMO

Genmab Announces Ofatumumab Development Plans in RRMS and NMO

Company Announcement

  *GSK plans to start additional pivotal studies of subcutaneous ofatumumab
  *Phase III studies in relapsing-remitting multiple sclerosis (RRMS)
    expected to start in 2015
  *IND filing planned for potential pivotal study in neuromyelitis optica
    (NMO)

COPENHAGEN, Denmark, May 30, 2014 (GLOBE NEWSWIRE) -- Genmab A/S
(Copenhagen:GEN) announced today its collaboration partner GlaxoSmithKline
(GSK) has taken the decision to start additional pivotal studies with the
subcutaneous formulation of ofatumumab. Phase III studies of subcutaneous
ofatumumab in RRMS are expected to begin in 2015, following encouraging data
from a Phase II study reported in October 2013.

In addition, GSK plans to file an IND for a potential pivotal study of
subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the
optic nerve and spinal cord, in 2014. Further details about the RRMS and NMO
programs will be available in due course. A Phase III study of subcutaneous
ofatumumab in pemphigus vulgaris, a rare autoimmune disorder of the skin, was
announced in 2013.

"We saw promising data in Phase II in relapsing-remitting multiple sclerosis
at the end of 2013 so we are very pleased that development of subcutaneous
ofatumumab will continue in this autoimmune disorder and look forward to
further development in NMO," said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.

About RRMS

Multiple Sclerosis (MS) is an inflammatory disease of the central nervous
system. MS is twice as common in females as in males, occurring with a peak
incidence at the age of 35 years and incidence varies widely in different
populations and ethnic groups. The etiology of MS remains unknown, but the
geographic variation points towards possible environmental and genetic
factors. The most common form of MS is relapsing-remitting MS (RRMS)
characterized by unpredictable recurrent attacks where the symptoms usually
evolve over days and are followed by either complete, partial or no
neurological recovery.^1

About NMO

Neuromyelitis optica, also known as Devic disease, is an autoimmune disorder
which leads to the loss of the protective covering (myelin) of the spinal cord
and optic nerves. Symptoms of NMO include eye pain, vision loss and transverse
myelitis which leads to numbness and paralysis of the arms and legs. Recovery
from relapses in NMO is incomplete, with accumulation of disability. NMO is a
rare disease with the highest reported incidence of four new cases diagnosed
per one million people annually.^1,2 There is currently no licensed therapy
for NMO.

About ofatumumab

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20
molecule encompassing parts of the small and large extracellular loops.^3
Ofatumumab is being developed under a co-development and collaboration
agreement between Genmab and GSK. Under the companies' agreement, GSK is
solely responsible for development of ofatumumab in autoimmune indications and
all related costs. Ofatumumab is not approved or licensed anywhere in the
world for RRMS or NMO.

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 currently has one
marketed antibody, Arzerra(r) (ofatumumab) for the treatment of certain
chronic lymphocytic leukemia indications, a clinical pipeline with both late
and early stage programs, and an innovative pre-clinical pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody(r) platform for generation of bispecific
antibodies, and the HexaBody(tm) platform which creates effector function
enhanced antibodies. Genmab's deep antibody expertise is expected to provide a
stream of future product candidates. Partnering of selected 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.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

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 logo(tm); HuMax^(r); HuMax-CD20^(r); DuoBody^(r);
HexaBody(tm) and UniBody^(r). Arzerra^(r) is a registered trademark of the GSK
group of companies.

^1 Noseworthy et al, N England J Med 2000; 343: 938-52
^2Marrie and Gryba, Int J MS Care 2013;15:113-118
^3Teeling et al,J Immunol2006; 177:362-371

Company Announcement no. 29
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
 
Press spacebar to pause and continue. Press esc to stop.