Theravance, Mylan expand commercial pact to China, adjacent areas

Theravance Biopharma Ireland Limited, a subsidiary of Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced the expansion of the companies’ current development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories. Revefenacin, marketed as YUPELRI^® in the U.S., is a long-acting muscarinic antagonist (LAMA), which is the first and only once-daily, nebulized bronchodilator approved for the treatment of chronic obstructive pulmonary disease (COPD) in the U.S.

It is estimated that COPD affects nearly 100 million individuals in China¹ with approximately 43 percent of those patients suffering from moderate to very severe forms of the disease². COPD is one of the top three causes of mortality in China, accounting for approximately 910,000 deaths annually³. COPD presents a significant financial burden to the healthcare system in China, contributing up to $266 billion in costs annually².

In 2015, Theravance Biopharma and Mylan, and their affiliates, established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases in all global markets with the exception of China and adjacent territories. Under terms of the new agreement, Theravance Biopharma has granted Mylan exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories, which include Hong Kong SAR, the Macau SAR and Taiwan. In exchange, Theravance Biopharma will receive an upfront payment of $18.5 million and will be eligible to receive additional potential development and sales milestones totaling $54 million together with tiered royalties on net sales of nebulized revefenacin, if approved.  Mylan will be responsible for all aspects of development and commercialization in the partnered regions, including pre- and post-launch activities and product registration and all associated costs.

https://www.prnewswire.com/news-releases/theravance-biopharma-and-mylan-expand-yupelri-revefenacin-development-and-commercialization-agreement-to-include-china-and-adjacent-territories-300867648.html