Theravance achieves 50% enrollment in all three phase 3 studies of Revefenacin

The revefenacin Phase 3 program, which includes two replicate efficacy studies and a single twelve-month long-term safety study, is designed to support the registration of the product in the U.S.

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. Under terms of the agreement, the achievement of the safety study enrollment milestone triggers a $15 million payment to Theravance Biopharma from Mylan.

Theravance Biopharma senior vice president of clinical development Brett Haumann said: "We are very pleased with the enrollment rate that we are seeing in the ongoing revefenacin efficacy studies and long-term safety study, which we believe underscores the interest in a once-daily nebulized COPD treatment.

"With no nebulized LAMA treatments currently available and approximately 9% of COPD patients in the U.S. currently using nebulizers for ongoing maintenance therapy1, we believe that there is an opportunity for revefenacin to serve as an important and differentiated COPD therapy."

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.

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.

About Theravance Biopharma and Mylan Strategic Collaboration

Theravance Biopharma and Mylan N.V. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Under the terms of the agreement, Theravance Biopharma is leading the U.S. 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-U.S. 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 U.S. sales and double-digit royalties on ex-U.S. 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.

About COPD

COPD is a growing and devastating disease that is the third leading cause of death in the U.S.2 An estimated 12.7 million American adults are diagnosed with COPD and an almost equal number are believed to be undiagnosed.3 There were more than 700,000 hospital discharges in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly $50 billion in 2010, including $29.5 billion in direct healthcare expenditures, $8 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.3

About Revefenacin

Revefenacin (TD-4208), is a novel investigational LAMA in development for the treatment of COPD. Theravance Biopharma has completed a successful Phase 2b program with revefenacin, administered once-daily via nebulizer for up to 28 days in a moderate-to-severe COPD population. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the U.S. use nebulizers for ongoing maintenance therapy.

LAMAs are a cornerstone of maintenance therapy for COPD, but are only available in handheld devices that may not be suitable for every patient. Revefenacin has the potential to be a best-in-class once-daily single-agent product for COPD patients who require, or prefer, nebulized therapy. The product’s stability in both metered dose inhaler and dry powder device formulations, suggest that this LAMA could also serve as a foundation for novel handheld combination products.