EC approves Relvar Ellipta

The European Commission approved an MAA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Relvar Ellipta fluticasone furoate/vilanterol to treat asthma and chronic obstructive pulmonary disease (COPD) in adults with a history of exacerbations. The approval triggers a $15 million milestone payment to GSK from partner Theravance Inc. (NASDAQ:THRX). The European launch of the product, which is slated for early next year, will trigger a second $15 million milestone payment to GSK from Theravance. The product -- a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and a long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler -- is approved in the U.S. and Canada as Breo Ellipta to treat airflow obstruction in patients with COPD and to reduce COPD exacerbations in patients with a history of exacerbations. The companies partnered to develop compounds to treat asthma and COPD in 2002.

Theravance is splitting into two publicly traded companies to separate its partnered late-stage respiratory assets from its R&D. One company -- Royalty Management Co. -- will manage all development and commercial responsibilities plus potential royalty revenues for LABA products partnered with GSK, including Relvar Ellipta (see BioCentury, April 29). ...