Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Corporate Update (October 2016)
7 slides from Theravance Biopharma's corporate update, Oct 20, 2016
Slide 1: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company are subject to risks and uncertainties that m
Slide 2: Revefenacin: Phase 3 Efficacy Study Design and Patient Population
2 Replicate, 12-week, randomized, double-blind, placebo-controlled, parallel group studies Revefenacin: Phase 3 Efficacy Study Design and Patient Population More than 1,250 moderate to very severe COPD patients across 120 U.S. study sites Revefenacin 88 mcg QD Placebo QD Revefenacin 175 mcg QD R Run
Slide 3: Revefenacin: Robust Improvements in FEV1 as Monotherapy and Add-on Therapy
Revefenacin: Robust Improvements in FEV1 as Monotherapy and Add-on Therapy Primary Endpoint Achieved for Both Doses FEV1 = Forced expiratory volume in one second; Add-on therapy = Revefenacin added to LABA or LABA/ICS * P < 0.0001 versus placebo ** P <0.001 versus placebo * ** * * * **
Slide 4: Consistent Treatment Effect Maintained for 24 hours with Once-Daily Dosing
Revefenacin: Consistent Treatment Effect Maintained for 24 hours with Once-Daily Dosing PD = Pre-dose; Note: 24-hour spirometry was assessed at baseline and after 12 weeks’ treatment in a subset of subjects in both studies Dose Dependent Effect on FEV1 with 175 mcg Consistently Better than 88 mcg (N
Slide 5: Low Incidence of Serious Adverse Events and Comparable to Placebo
Revefenacin: Low Incidence of Serious Adverse Events and Comparable to Placebo n=1256; 1 subject was randomized but not dosed and is included in the safety population but not the efficacy population Description Placebo (N=429) 88mcg (N=425) 175mcg (N=402) Serious Adverse Events 21 (5%) 21 (5%) 15 (4
Slide 6: Positive Results in Replicate Studies
Revefenacin: Positive Results in Replicate Phase 3 Efficacy Studies Robust and sustained improvements in FEV1 Effective as monotherapy and as add-on to LABA or LABA/ICS Generally well tolerated FEV1 = Forced expiratory volume in one second LABA = Long-acting-beta-agonist; ICS – Inhaled corticosteroi
Slide 7: Positive Results in Replicate Studies
Revefenacin: Positive Results in Replicate Phase 3 Efficacy Studies Primary Endpoint Met in Both Studies and at Both Doses ” Robust and sustained improvements in FEV, A” Effective as monotherapy and as add-on to LABA or LABA/ICS A Generally well tolerated Theravance uv second Inhaled corticosteroid
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