| GLAXOSMITHKLINE AND HUMAN GENOME SCIENCES RECEIVE EUROPEAN AUTHORIZATION FOR BENLYSTA® (BELIMUMAB) | |
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LONDON, UK and ROCKVILLE, Maryland – July 14, 2011 – GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Commission (EC) has granted marketing authorization for BENLYSTA® (belimumab) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. “The European approval of BENLYSTA represents a significant milestone, and we are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease,” said Dr. Tony Hoos, Senior VP, European Medical Affairs, GSK. “We and GSK are committed to making BENLYSTA available in countries worldwide,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We are particularly honored to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development.” The European summary of product characteristics (SmPC) lists patient groups which have not been studied with belimumab, including severe active CNS lupus or severe active lupus nephritis. Use of belimumab is therefore not recommended to treat these conditions. Caution should be exercised if belimumab is co-administered with other B-cell targeted therapy or cyclophosphamide, as it has not been studied in combination with these agents. About BENLYSTA (belimumab)
Regulatory applications have been submitted and are currently under review in Australia, Switzerland, Russia, Brazil, The Philippines, Israel, Singapore, Taiwan and Colombia. Detailed recommendations for the use of belimumab are described in the SmPC, which will be published in the European public assessment report (EPAR http://www.emea.europa.eu). About the GSK/HGS collaboration
BENLYSTA is a registered trademark owned by Human Genome Sciences, Inc., used under license by the GlaxoSmithKline group of companies. 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. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease. Human Genome Sciences exists to place new therapies into the hands of those battling serious disease. For more information about HGS, please visit the Company’s web site at www.hgsi.com. HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners. GlaxoSmithKline cautionary statement regarding forward-looking statements
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