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GlaxoSmithKline, Innoviva launch phase 3 study of asthma therapy

Theravance Biopharma Inc. reported that GlaxoSmithKline PLC and Innoviva Inc. have commenced a phase 3 study of a once-daily triple-combination therapy in patients with asthma.

Delivered as a single dose using GlaxoSmithKline's Ellipta inhaler, the once-daily triple-combination therapy consists of fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta-2-adrenergic agonist. The study will compare the triple-combination therapy against a fluticasone/vilanterol dual combination therapy, branded as Relvar/Breo.

The triple combination therapy is also being developed for the treatment of chronic obstructive pulmonary disease. GlaxoSmithKline and Innoviva recently filed for a new drug application in the U.S. and a marketing authorization application in the EU for the once-daily therapy to be used in this indication.

As part of an agreement with Innoviva, Theravance Biopharma is entitled to receive an 85% financial interest in royalties paid by GlaxoSmithKline if the triple-combination therapy is eventually approved and commercialized. The royalties are upward-tiering from 6.5% to 10%. Theravance Biopharma is also not responsible for any cost related to the triple-combination therapy.