Genmab — Regulatory Filings 2013

Oct 10, 2013

News Details

Ad-hoc | 10 October 2013 19:47

Genmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple Sclerosis

Genmab A/S

10.10.2013 19:47

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The issuer is solely responsible for the content of this announcement.

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Company Announcement

-- Treatment with ofatumumab showed significant reduction in the cumulative
number of new brain lesions
-- No unexpected safety findings

Copenhagen, Denmark; October 10, 2013 - Genmab A/S (OMX: GEN) announced today
top-line results from a Phase II study of the subcutaneous formulation of
ofatumumab in relapsing-remitting multiple sclerosis (RRMS).

A total of 232 subjects with RRMS were randomized in the study. There was a
clear separation from placebo on the cumulative number of new gadolinium
enhancing lesions (active brain lesions) over a period of 12 weeks in subjects
treated with all doses of ofatumumab compared to subjects treated with placebo
[p < 0.001]. For the primary endpoint, analysis of data from weeks 0-12
estimated a 65% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all doses [p < 0.001]. In weeks 4-12, analyses of data
estimated a >= 90% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all cumulative doses of ofatumumab >= 30 mg [p < 0.001].

There were no unexpected safety findings in the study. From weeks 0-12,
injection related reactions were the most common adverse reaction and were
observed in 52% of subjects receiving ofatumumab compared to 15% of subjects
receiving placebo. There were five serious adverse events (SAEs) reported, all
subjects received a 60 mg dose of ofatumumab and none of these subjects
withdrew from the study. Twelve subjects withdrew during this time period; 10
of these subjects were receiving ofatumumab. To date, no cases of progressive
multifocal leukoencephalopathy (PML) or opportunistic infections have been
observed.

'We are encouraged by the results from this study, which we believe underline
the potential of subcutaneous ofatumumab for treatment of relapsing-remitting
multiple sclerosis,' said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.

About the study
This multi-center, randomized, double-blind, placebo controlled Phase II study,
conducted by GlaxoSmithKline (GSK), included subjects who had RRMS. The
primary objective of the study was to determine whether 3, 30 or 60 mg of
ofatumumab given subcutaneously reduces the number of new T1-weighted
gadolinium-enhancing brain lesions (active brain lesions) over a period of 12
weeks, as compared with placebo, in subjects with RRMS.

Subjects in the study were randomized to one of the following treatment arms: 3
mg, 30 mg, or 60 mg of subcutaneous ofatumumab every 12 weeks or 60 mg of
subcutaneous ofatumumab every 4 weeks, or placebo followed by 3 mg of
subcutaneous ofatumumab at week 12. The treatment period for all subjects was
24 weeks; subjects were then followed until B-cell repletion for at least an
additional 24 weeks. Currently, all subjects have completed the 24-week
treatment period; some subjects continue to be followed as per protocol.

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.

About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20
molecule encompassing parts of the small and large extracellular loopsi.
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.

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.

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

iTeeling et al, J Immunol 2006

Company Announcement no. 42
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

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Language: English
Company: Genmab A/S

          Dänemark

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Internet:
ISIN: DK0010272202
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