Theravance Biopharma Highlights Positive Top-Line Results From Pivotal Phase 3 FULFIL Study of the Closed Triple Announced by GlaxoSmithKline and Innoviva

DUBLIN, IRELAND--(Marketwired - Jun 20, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today announced that GlaxoSmithKline plc (GSK) and Innoviva, Inc. (Innoviva) have disclosed positive top-line results from the pivotal Phase 3 FULFIL study of the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol) in patients with chronic obstructive pulmonary disease (COPD). Data demonstrated superiority for the Closed Triple as compared to Symbicort^® Turbohaler^® in improving lung function and health-related quality of life in COPD patients. 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 on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%. Additionally, GSK is responsible for all development costs related to the Closed Triple with no costs being borne by Theravance Biopharma.

In an announcement made on June 20, 2016, GSK and Innoviva stated that the FULFIL study met its two co-primary endpoints, demonstrating statistically significant improvements compared with twice-daily Symbicort Turbohaler (budesonide/formoterol 400/12mcg) in both lung function as measured by trough FEV₁ (171mL, 95% confidence interval [148, 194] p < 0.001), and health-related quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) (-2.2 units, 95% confidence interval [-3.5, -1.0] p < 0.001), at the end of the 24-week study period. The proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on FF/UMEC/VI and 41% on budesonide/formoterol. Additionally, GSK and Innoviva announced that the safety profile for the Closed Triple at both 24 weeks and the 52-week extension was consistent with the known profile of the individual medicines and their combinations. GSK has indicated that findings from the FULFIL study support its plans to submit regulatory filings for the approval of the Closed Triple for the treatment of COPD in both the U.S. and EU by the end of 2016.