BioCentury
ARTICLE | Company News

EC approves GSK's Anoro

May 9, 2014 12:03 AM UTC

The European Commission approved an MAA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Anoro umeclidinium/vilanterol as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). The approval triggers a $15 million milestone payment to GSK from Theravance Inc. (NASDAQ:THRX). GSK and Theravance are partnered under a 2002 deal to develop compounds to treat asthma and COPD, including Anoro. The European launch of Anoro will trigger another $15 million milestone payment; the partners plan to launch the product before the end of next quarter.

GSK and Theravance market the product in the U.S. as Anoro Ellipta. The product -- a fixed-dose inhaled dry powder formulation of a long-acting muscarinic antagonist (LAMA) and a long-acting adrenergic receptor beta 2 agonist (LABA) -- is also approved in Canada and under review in Japan. ...