Theravance Biopharma Completes Enrollment in All Three Phase 3 Clinical Studies of Revefenacin (TD-4208) for Treatment of Chronic Obstructive Pulmonary Disease (COPD) - Seite 2

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.¹ An estimated 12.7 million American adults are diagnosed with COPD and an almost equal number are believed to be undiagnosed.² 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.²

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.³ 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.