GSK and Genmab Announce Start of Ofatumumab Phase III Combination Study in Non-Hodgkin's Lymphoma

Genmab A/S / 

08.09.2010 23:00

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Summary: GSK and Genmab announce the initiation of a Phase III study of         
ofatumumab in rituximab refractory patients with indolent B-cell non-Hodgkin's  
Lymphoma.                                                                       

London, UK, Copenhagen, Denmark; September 8, 2010 - GlaxoSmithKline (GSK) and  
Genmab A/S (OMX: GEN) announced today the start of a Phase III study in patients
with indolent B-cell non-Hodgkin's lymphoma (B-NHL) who did not respond to or   
progressed during, or within 6 months of a rituximab containing regimen.  Under 
the terms of Genmab's collaboration with GlaxoSmithKline (GSK), Genmab will     
receive a milestone payment of approximately DKK 116 million (approximately USD 
20 million), triggered by the treatment of the first patient in the study.      

About the trial                                                                 
A total of 338 patients in this open label study will be randomized to receive  
either ofatumumab in addition to bendamustine or bendamustine alone. The primary
endpoint of the study is progression free survival. Patients in the bendamustine
monotherapy group will have the opportunity to receive ofatumumab if their      
lymphoma progresses.                                                            

About Indolent B-Cell Non-Hodgkin's Lymphoma                                    
More than one-third of lymphoma patients have indolent B-cell non-Hodgkin's     
lymphoma, which includes follicular lymphoma and other typically slow growing   
lymphomas which initially respond to treatment but relapse with time.(1)        
Indolent B-NHL is defined by expression of the CD20 molecule, which is the      
target of monoclonal antibodies such as rituximab and ofatumumab.(2,3)          

About ofatumumab                                                                
Ofatumumab is a human monoclonal antibody which targets CD20. Ofatumumab is not 
approved in any country for indolent B-cell non-Hodgkin's lymphoma (B-NHL).     

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.                                                           

About GlaxoSmithKline                                                           
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 company           
information, visit GlaxoSmithKline at http://www.gsk.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  
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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                                      

References                                                                      
1. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review    
1975-2006, National Cancer Institute.                                           

2. McLaughlin, Peter. Mayo Clinic Hematology/Oncology Review: Part 1 Progress   
and Promise in the Treatment of Indolent Lymphomas. The Oncologist, June 2002   
Vol. 7, No. 3, 217-225.                                                         

3. Cheson, Bruce D. Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the   
Treatment of B-Cell Malignancies. Journal of Clinical Oncology. July 20, 2010   
vol.28 no. 21 3525-3530.                                                        
                                                                                
Stock Exchange Release no. 31/2010                                              

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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:          
 
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