Genmab Announces Ofatumumab Development Plans in RRMS and NMO
30 Mayo 2014 - 10:04AM
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
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changes and developments in technology which may render our
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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 3 Teeling et
al, J Immunol 2006; 177:362-371
Company Announcement no. 29 CVR no. 2102 3884
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