Theravance Biopharma Highlights Acceleration of Timeline for Filing U.S. New Drug Application for the Closed Triple by GlaxoSmithKline and Innoviva

DUBLIN, IRELAND--(Marketwired - Jun 2, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today announced that GlaxoSmithKline plc (GSK) and Innoviva, Inc. (Innoviva) have accelerated the timeline for filing a New Drug Application (NDA) in the U.S. for the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol) for patients with chronic obstructive pulmonary disease (COPD). In an announcement made on June 2, 2016, GSK and Innoviva stated that following discussions with the U.S. Food and Drug Administration (FDA), they now plan to submit the U.S. regulatory filing by the end of 2016, as opposed to the previously expected first half of 2018. The announcement also noted that the companies continue to expect an EU regulatory submission of the Closed Triple combination therapy in COPD by the end of 2016. 

The Closed Triple is one of the drug development programs for which Theravance Biopharma has an economic interest in future payments that may be made by GSK or one of its affiliates pursuant to its agreements with Innoviva (formerly Theravance, Inc.). Should the Closed Triple be successfully developed and commercialized, Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK in worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%.

The Closed Triple combination therapy represents a unique approach to COPD treatment by seeking to combine the activity of three molecules with different mechanisms of action in a single delivery device. The combination treatment includes: fluticasone furoate (FF), an inhaled corticosteroid; umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta₂-adrenergic agonist (LABA). This combination has been formulated to be delivered once-daily in GSK's Ellipta^® dry powder inhaler.

The ongoing clinical development program for the Closed Triple in COPD consists of the FULFIL and IMPACT studies, two Phase 3 trials designed to evaluate the effectiveness and safety of the combination treatment compared to existing COPD therapies. Data from the FULFIL trial is expected later in 2016, with results from the IMPACT study anticipated in 2017¹.

Notes:
¹Regulatory and clinical milestones as reported by Glaxo Group Limited or one of its affiliates (GSK)

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