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Re: surf1944 post# 50

Friday, 05/10/2013 2:00:20 PM

Friday, May 10, 2013 2:00:20 PM

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12:38PM Theravance and GlaxoSmithKline (GSK) confirm BREO ELLIPTA gains U.S. approval for the treatment of COPD (THRX) 34.59 +3.28 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announced that the FDA has approved BREO ELLIPTA as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg). Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA.

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