Theravance Biopharma Completes Enrollment in All Three Phase 3 Clinical Studies of Revefenacin (TD-4208) for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

DUBLIN, IRELAND--(Marketwired - Jun 1, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that enrollment has been completed in each of the three ongoing clinical trials comprising the Company's 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 revefenacin Phase 3 program, which includes two replicate efficacy studies and a single twelve-month safety study, is designed to support the registration of the product in the U.S.

More than 2,300 patients have been enrolled across the three studies in approximately eight months. Top-line data from the two efficacy studies are expected to be available in late-Q3 or early-Q4 2016, with the data from the twelve-month safety trial following in 2017. Should outcomes from these studies be positive, Theravance Biopharma expects to file a new drug application (NDA) for revefenacin with the United States Food and Drug Administration (FDA) by the end of 2017. Theravance Biopharma and its affiliates have partnered with Mylan N.V. and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases.

"We are very pleased with our clinical investigators' ability to identify appropriate patients to enroll in the Phase 3 program. We believe this may bode well for how readily physicians are able to identify suitable patients in the future, if revefenacin is successfully approved. We look forward to completing the studies so that we can analyze the results," said Brett Haumann, MD, Chief Medical Officer at Theravance Biopharma. "Based on its competitive advantages, including once-daily dosing and compatibility with any standard jet nebulizer, we believe that, if approved, revefenacin has the potential to benefit a significant number of COPD patients who require once-daily LAMA treatment but for whom handheld inhaler devices are not suitable."

The ongoing Phase 3 efficacy and safety studies are testing two doses (88 mcg and 175 mcg) of revefenacin inhalation solution administered once daily via nebulizer in moderate to severe COPD patients. 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 twelve weeks, with a primary endpoint of trough forced expiratory volume in one second (FEV₁) on day 85. The Phase 3 twelve-month safety trial is an open-label, active comparator study. More information about the trials is available at www.clinicaltrials.gov.