Theravance Biopharma Presents Additional Positive Phase 2b Study Data on TD-4208 for Treatment of COPD at American Thoracic Society 2015 International Conference

GEORGE TOWN, GRAND CAYMAN--(Marketwired - May 20, 2015) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced the presentation of additional positive data from its Phase 2b dose-ranging study of TD-4208, an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD). Previously released top-line study data demonstrated achievement of the study's primary and key secondary efficacy endpoints for doses of 88 mcg and above. Additional trial results presented today support the product's potential to offer patients rapid and sustained therapeutic benefit from once-daily administration and to reduce the requirement for short-acting rescue medication. These latest data are being presented at the American Thoracic Society (ATS) 2015 International Conference being held this week in Denver, Colorado.

The Phase 2b study evaluated four doses of TD-4208 (44, 88, 175 and 350 mcg) and placebo, administered once-daily for 28 days in a double-blind, parallel group study in a total of 355 patients with moderate-to-severe COPD. As previously reported, TD-4208 met the primary efficacy endpoint (change from baseline in trough FEV₁ [forced expiratory volume in one second] following the last dose on Day 28) at once-daily doses of 88, 175 and 350 mcg, with statistically significant changes versus placebo (p < 0 .001) in trough FEV₁ of 187 mL, 167 mL and 171 mL, respectively. TD-4208 was generally well tolerated in the study with headache (3.1%), shortness of breath (2.8%) and cough (2.0%) as the most common adverse events in the study.

In new data from the Phase 2b study reported at ATS, TD-4208 resulted in a rapid onset of action, with a median time to achieve a clinically relevant improvement in lung function (at least 100mL increase in FEV₁) of 30 minutes for doses of 88 mcg and above. TD-4208 also reduced the requirement for short-acting inhaled rescue medication in a dose-dependent manner, with a mean reduction of more than one puff a day compared to placebo for doses of 88 mcg and above (p < 0.001).