Theravance Biopharma and Mylan have expanded their 2015 development and commercialization agreement for nebulized revefenacin (formerly TD-4208) to include China, Hong Kong, Macau, and Taiwan. The 2015 agreement included all markets except for China and the additional territories that have now been added.
Mylan will pay Theravance $18.5 million up front and up to $54 million in development and sales milestones along with tiered royalties on net sales if the revefenacin inhalation solution is approved in the additional markets. Mylan will be also take responsibility for all development and commercialization activities and costs in those regions.
Theravance Biopharma Chairman and CEO Rick E Winningham said, “We are pleased to expand our ongoing revefenacin development and commercialization collaboration with Mylan to include China, as we believe that this novel compound has the therapeutic profile to provide key benefits to the country’s large and underserved COPD patient population. Our companies share the belief that revefenacin can play a critical role in COPD treatment, particularly for those patients who require or prefer nebulized therapy. Mylan is a global leader in nebulized respiratory therapies and has been a valued and trusted partner since we entered our original collaboration in 2015. Based on its deep experience with nebulized revefenacin, Mylan is well positioned to efficiently guide the compound through the development and regulatory approval process in China, as well as maximize its commercial potential in the partnered regions.”
Mylan President Rajiv Malik commented, “Mylan has had a long-term, strategic focus on its growing presence in China, one of the world’s largest pharmaceutical markets. Our expanded partnership on revefenacin represents a natural next step, and together with Theravance Biopharma we look forward to making a meaningful difference for the millions of patients living with COPD in China. Through our continued investment in a comprehensive portfolio of products across the value chain, our deep understanding of the evolving Chinese healthcare landscape, our scientific excellence and innovation, and our industry-leading pipeline, we look forward to continue meeting unmet needs for patients in China and the world over.”
Read the Theravance Biopharma and Mylan press release.
