Theravance Biopharma & Mylan Initiate Phase III Program

Theravance Biopharma, Inc. and Mylan N.V. recently announced the initiation of a Phase III 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 III program, designed to support the registration of the product in the US, includes two replicate 3-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 US currently use nebulizers for ongoing maintenance therapy, and a total of 41% of US COPD patients use nebulizers for bronchodilator therapy at some time during the course of their disease,” 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 III 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 III 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,” added 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 III efficacy studies and one Phase III safety study, examining two doses (88 mcg and 175 mcg) of revefenacin inhalation solution administered once-daily via nebulizer in moderate-to-severe patients with COPD. The Phase III 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 III 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.

Theravance Biopharma and Mylan N.V. and its affiliates have partnered to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Under the terms of the agreement, Theravance Biopharma is leading the US development program for the revefenacin inhalation solution product, with all costs reimbursed by Mylan up until the approval of the first new drug application, after which costs will be shared. Mylan is responsible for ex-US development and commercialization. Theravance Biopharma is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on US sales and double-digit royalties on ex-US sales. Additionally, Theravance Biopharma retains worldwide rights to revefenacin delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI), and the rights to nebulized revefenacin in China.