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Glaxosmithkline Plc and Theravance Inc's Relvar Ellipta Receives Marketing Authorization from European Commission


Monday, 18 Nov 2013 08:16am EST 

Glaxosmithkline Plc and Theravance Inc announced that the European Commission has granted marketing authorization for Relvar Ellipta, which is thus licensed across 31 European countries for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate; for patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting beta2-agonists; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. Under the terms of the 2002 LABA collaboration agreement, Theravance Inc is obligated to make a milestone payment to Glaxosmithkline Plc of USD 15 million following marketing authorization for Relvar Ellipta from the European Commission. A further USD 15 million payment to Glaxosmithkline Plc will follow the launch of Relvar Ellipta in Europe.