DGAP-Adhoc: GSK and Genmab Announce European Submission to Regulatory Authorities for Arzerra(r) (Ofatumumab) as 1st Line

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

Genmab A/S 

04.10.2013 09:58

Dissemination of a Adhoc News, transmitted by DGAP - a company of EQS Group
AG.
The issuer is solely responsible for the content of this announcement.

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Company Announcement

  -- Application to broaden label for Arzerra to include 1st line CLL submitted
     to the EMA
  -- First application to modify label indication for Arzerra since approval

Copenhagen, Denmark; October 4, 2013 - GlaxoSmithKline plc (LSE/NYSE: GSK) and
Genmab A/S (OMX: GEN) announced today the submission of a variation to the
Marketing Authorization to the European Medicines Agency (EMA) 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 submission is based primarily on results from an international,
multi-center, randomized Phase III study of ofatumumab 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 have been submitted for presentation 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. In Europe, the incidence
rate is 4.92 per 100,000 or approximately 11,019 new cases each year1. 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 commercialization
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
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. 

Genmab 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

GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley           +44 (0) 20 8047 5502     (London)
Simon Steel                  +44 (0) 20 8047 5502     (London)
David Daley                  +44 (0) 20 8047 5502     (London)
Catherine Hartley          +44 (0) 20 8047 5502     (London)

US Media enquiries:
Melinda Stubee             +1 919 483 2510            (North Carolina)
Catalina Loveman         +1 215 751 4958            (Philadelphia)
Anna Padula                 +1 215 751 4271            (Philadelphia)
Karen Collins                 +1 919 483 2527            (North Carolina)
Stephen Rea                 +1 215 751 4394            (Philadelphia)
Jennifer Armstrong        +1 215 751 5664            (Philadelphia)

Analyst/Investor enquiries:
Ziba Shamsi                  + 44 (0) 20 8047 3289    (London)
Tom Curry                     + 1 215 751 5419           (Philadelphia)
Gary Davies                  + 44 (0) 20 8047 5503    (London)
James Dodwell             + 44 (0) 20 8047 2406    (London)
Jeff McLaughlin             + 1 215 751 7002           (Philadelphia)
Lucy Singah                  +44 (0) 20 8047 2248     (London)



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); 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 GlaxoSmithKline. 

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. 

Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS



1Sant et al, Blood 2010; 116;3724-3734
2Teeling et al, J Immunol 2006; 177:362-371


Company Announcement no. 41
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

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News Source: NASDAQ OMX



04.10.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
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Language:     English
Company:      Genmab A/S
              
               
              Denmark
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         DK0010272202
WKN:          
 
End of Announcement                             DGAP News-Service
 
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