Theravance Biopharma and Mylan have agreed to extend the development and commercialization of Yupelri (inhalation solution of revefenacin) — the first and only once-daily nebulized bronchodilator approved for chronic obstructive pulmonary disease (COPD) — to China and neighboring territories.
The agreement could make Yupelri available in the future to the nearly 100 million COPD patients living in China, where 43% have moderate to severe forms of the disease, and COPD is in one of the three top causes of death.
Under the deal, Theravance Biopharma has granted Mylan exclusive rights for developing and selling Yupelri in China and adjacent territories, including Hong Kong, Macau, and Taiwan. In turn, Theravance Biopharma is paid $18.5 million and remains eligible for additional payments and royalties on net sales, if the product is approved.
“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,” Rick E. Winningham, chairman and CEO of Theravance Biopharma, said in a press release.
“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,” he said.
Yupelri is a long-acting muscarinic antagonist (LAMA) administered once daily via a nebulizer and indicated for the maintenance treatment of adults with COPD. It acts as an anticholinergic bronchodilator to help keep the bronchial muscles in the lungs relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. The medicine is intended for COPD patients who require, or prefer, nebulized therapy.
Pill and liquid versions of LAMAs were available before Yupelri’s approval in the U.S. in 2018, when it became the first approved LAMA to be delivered as a mist, compatible with common nebulizers.
The stability of revefenacin, Yupelri’s active ingredient, in both metered dose inhaler and dry powder formulations also suggests the medicine could work in novel handheld combination products, Mylan said.
“Mylan has had a long-term, strategic focus on its growing presence in China, one of the world’s largest pharmaceutical markets,” said Rajiv Malik, president of Mylan. “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.”