Theravance Biopharma, Mylan Report Initiation of Phase 3 Program for Revefenacin for the Treatment of COPD

Theravance Biopharma, Inc. TBPH ("Theravance Biopharma") and Mylan N.V. MYL ("Mylan") today announced the initiation of a Phase 3 program for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD). The Phase 3 program, designed to support the registration of the product in the U.S., includes two replicate three-month efficacy studies and a single 12-month safety study. "Despite the fact that once-daily LAMAs are the first-line therapy for patients with moderate-to-severe COPD, there still are no nebulized LAMA treatments available today. This unmet need is significant when one considers that approximately 9% of COPD patients in the U.S. currently use nebulizers for ongoing maintenance therapy, and a total of 41% of U.S. COPD patients use nebulizers for bronchodilator therapy at some time during the course of their disease,"(1) said Brett Haumann, MD, Senior Vice President, Clinical Development at Theravance Biopharma. "Based on data that we've generated to date, we believe that revefenacin possesses the product profile that could uniquely and effectively address this market need. We look forward to conducting this Phase 3 program in collaboration with our partner Mylan to generate the data required to support a regulatory filing for the product." "The initiation of this Phase 3 program is an important milestone for Mylan as we continue to further build out our global respiratory pipeline. Revefenacin is highly complementary to our currently marketed nebulized COPD product, Perforomist® Inhalation Solution, as well as other respiratory products in our pipeline. We are excited by the potential to offer healthcare professionals, and ultimately patients, an even more robust respiratory portfolio if revefenacin is approved," said Mylan President Rajiv Malik. "Theravance Biopharma has done an excellent job advancing revefenacin to this stage of development and we look forward to contributing our expertise and leadership in the area of nebulized respiratory therapy as we work together to bring this important product to market." The revefenacin development program includes two Phase 3 efficacy studies and one Phase 3 safety study, examining 2 doses (88 mcg and 175 mcg) of revefenacin inhalation solution administered once-daily via nebulizer in moderate to severe patients with COPD. The Phase 3 efficacy studies are replicate, randomized, double-blind, placebo-controlled, parallel-group trials designed to provide pivotal efficacy and safety data for once-daily revefenacin over a dosing period of 12 weeks, with a primary endpoint of trough forced expiratory volume in one second (FEV1) on day 85. The Phase 3 safety study is an open-label, active comparator study of 12 months duration. Together, the three studies will enroll approximately 2,300 patients. Theravance Biopharma expects the results to be available from the two efficacy studies in 2016, with the results of the safety study available in 2017. More information about the trials is available at www.clinicaltrials.gov.