Theravance and Mylan expand agreement for nebulised revefenacin

Theravance Biopharma Ireland and Mylan have expanded their existing development and commercialisation agreement for nebulised revefenacin.

The latest agreement will include distribution to areas such as China and its adjacent territories.

Marketed as YUPELRI in the US, revefenacin is a long-acting muscarinic antagonist (LAMA) that is approved for the treatment of chronic obstructive pulmonary disease (COPD) in China. COPD accounts for about 910,000 deaths a year in the country.

Theravance Biopharma and Mylan first began collaborating in 2015 for the development and commercialisation of nebulised revefenacin products for COPD and other respiratory diseases in markets around the globe, excluding China and adjacent territories.

Theravance Biopharma chairman and CEO Rick Winningham said: "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.

"Based on its deep experience with nebulised revefenacin, Mylan is well positioned to efficiently guide the compound through the development and regulatory approval process in China, as well as maximise its commercial potential in the partnered regions."

Under the expanded agreement, Mylan secured exclusive development and commercialisation rights from Theravance Biopharma to the inhalation solution in Hong Kong, S.A.R., China SAR, the Macau, S.A.R., China SAR and Taiwan, China.

Theravance Biopharma will receive an upfront payment of $18.5m in exchange, as well as a total of $54m in additional potential development and sales milestones with tiered royalties on net sales of the product once approved.

All aspects of development and commercialisation in the partnered regions will be handled by Mylan.

Mylan president Rajiv Malik said: "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 continuing meeting unmet needs for patients in China and the world over."

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