GlaxoSmithKline and Genmab A/S announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra™ (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL). If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. Ofatumumab targets a distinct binding site on the CD20 molecule of B-cells and it could become the first monoclonal antibody targeted to CD20 available for these patients. GSK and Genmab announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) on Friday 30 January 2009.
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\nGlaxoSmithKline and Genmab A/S announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra™ (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL). If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. Ofatumumab targets a distinct binding site on the CD20 molecule of B-cells and it could become the first monoclonal antibody targeted to CD20 available for these patients. GSK and Genmab announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) on Friday 30 January 2009.
\nCLL is the most common form of leukaemia in the Western world1,2 and patients have a high need for new therapy options. Currently fewer than 25 percent of patients with refractory CLL respond to current treatments resulting in much poorer clinical outcomes.3
\n“Ofatumumab is a new generation of monoclonal antibody that may provide an important new treatment for patients suffering from CLL and we plan additional studies to understand its potential in lymphomas and selected autoimmune diseases,” said Carlo Russo, Senior Vice President BioPharm, GSK. \"The filing of ofatumumab for refractory CLL represents the strong ongoing partnership between the GSK BioPharm and Oncology Units to develop therapies based upon novel biopharmaceutical platforms.”
\n“The submissions of ofatumumab to the FDA and EMEA within a seven day period exemplify our commitment to providing new therapeutic options for patients with CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We are also collaborating with GSK to study ofatumumab in other conditions with the goal of providing important new treatment options to patients suffering from debilitating and life threatening diseases.”
\nOfatumumab is a novel, investigational, fully-human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells.4 This epitope is different from the binding sites targeted by other CD20 antibodies currently available. 5 The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies. 6
\nOfatumumab is being developed under a co-development and commercialisation agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country. In Europe, ofatumumab has been granted orphan designation for CLL as it affects approximately 3.5 in 10,000 persons in the European Union.8
\nCLL is the most common adult leukaemia1,2 and one of the most common malignant lymphoid diseases.7 Based on 2007 worldwide estimates, leukaemia accounted for more than 330,000 new cases and more than 245,000 deaths.9
\nGlaxoSmithKline – 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.
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s revolutionary ‘bench to bedside’ approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.
GSK’s BioPharm R&D division has a rich early pipeline based on cutting edge molecular biology and genetic technology and a mature late-stage portfolio that will provide important medicines to oncology.
\nGenmab A/S is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world class discovery, development and manufacturing 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.
\nArzerra™ is the proposed registered trademark to be used in the United States and Europe.
\nTo access the latest GSK Oncology media materials, visit www.gskcancermedia.com
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\nGlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
This press 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 press release nor to confirm such statements in relation to actual results, unless required by law.
\n1 American Cancer Society. Cancer Facts and Figures 2008. http://cancer.org/. Accessed 28 January 2009
\n2 Eichhorst B. Chronic lymphocytic leukemia: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008. 19:60-62. doi:10.1093/annonc/mdn090.
\n3 Tam CS, O'Brien S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leukemia and Lymphoma 2007;48(10):1931-1939
\n4 Hagenbeek A, Gadeberg O, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood, 2008; 111: 5486-5495
\n5 Teeling JL, Mackus, W,J., et al. The Biological Activity of Human CD20 Monoclonal Antibodies Is Linked to Unique Epitopes on CD20. J Immunol 2006; 177: 362-371
\n6 Glennie MJ, French RR, et al. Mechanisms of killing by anti-CD20 monoclonal antibodies. Molecular Immunology, 2007;44 (16):3823-3837
\n7 Shanafelt TD, Byrd JC, et al. Narrative review: initial management of newly diagnosed, early-stage chronic lymphocytic leukemia. Ann Intern Med. 2006 Sep 19;145(6):435-47.
\n8 European Medicines Agency. Public Summary of Positive Opinion for Orphan Designation of Ofatumumab www.emea.europa.eu/pdfs/human/comp/opinion/48024408en.pdf Accessed 5 February 2009
\n9 American Cancer Society. Cancer Facts and Figures 2007. http://cancer.org/. Accessed 28 January 2009
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