Genmab Announces Results of Ofatumumab Phase II Study in Multiple Sclerosis

Genmab A/S 

10.09.2010 18:47

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Summary:  Genmab announces 48 week results from a Phase II study of ofatumumab  
in RRMS.                                                                        

Copenhagen, Denmark; September 10, 2010 - Genmab A/S (OMX: GEN) announced today 
encouraging results from an ofatumumab Phase II safety and pharmacokinetics     
study in patients with relapsing-remitting multiple sclerosis (RRMS).           

A total of 38 patients were included in this double-blind, dose escalation      
trial.  Patients were randomized to receive two infusions of 100 mg, 300 mg or  
700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to     
placebo were treated with ofatumumab and patients who were treated with         
ofatumumab received placebo.  All patients were then followed for an additional 
24 weeks.                                                                       

In the study, there were no dose limiting toxicities, no unexpected safety      
findings, and no patients tested positive for human anti-human antibodies.      
Efficacy was assessed by MRI (magnetic resonance imaging) as a secondary        
endpoint. Repeated MRI scans showed a sustained reduction in the number of brain
lesions up to week 48 in patients (n=26) who were treated with ofatumumab       
followed by placebo. Patients who received placebo followed by ofatumumab (n=12)
showed similar 24 week results to those who were treated with ofatumumab        
followed by placebo.                                                            

About RRMS                                                                      
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous       
system.  MS is twice as common in females as in males, occurs 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 characterized by           
unpredictable recurrent attacks where the symptoms usually evolve over days and 
are followed by either complete, partial or no neurological recovery. No        
progression of neurological impairment is experienced between attacks.          

About ofatumumab                                                                
Ofatumumab is a novel human monoclonal antibody.  It targets a part of the CD20 
molecule on B-cells encompassing an epitope in the small loop.                  
Ofatumumab is being developed under a co-development and commercialization      
agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in 
any country for RRMS.                                                           

About Genmab A/S                                                                
Genmab is a leading international biotechnology company focused on developing   
fully human antibody therapeutics for the potential treatment of cancer.        
Genmab's world class discovery and development teams are using cutting-edge     
technology to create and develop products to address unmet medical needs.  Our  
primary goal is to improve the lives of patients who are in urgent need of new  
treatment options.  For more information on Genmab's products and technology,   
visit www.genmab.com.                                                           

This Stock Exchange Release 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   
product discovery and development, 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 section   
'Risk Management' in Genmab's Annual Report, which is available on              
www.genmab.com.  Genmab does not undertake any obligation to update or revise   
forward looking statements in this Stock Exchange Release nor to confirm such   
statements in relation to actual results, unless required by law.               

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GlaxoSmithKline.                                                                

Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,  
M: +45 25 27 47 13, E: h.husted@genmab.com                                      
                                                                                
Stock Exchange Release no. 32/2010                                              

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News Source: NASDAQ OMX



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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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