- Theravance Biopharma (TBPH -3.1%) and development/commercialization partner Mylan N.V. (MYL -1.2%) announce the filing of a New Drug Application (NDA) in the U.S. seeking approval for revefenacin (TD-4208) for the once-daily treatment of chronic obstructive pulmonary disease (COPD).
- The companies are collaborating on the development of the long-acting nebulized bronchodilator. Theravance is leading U.S. development while Mylan is responsible for ex-U.S. development and commercialization. Theravance is eligible to receive up to $220M in development- and sales-related milestones and double-digit royalties on ex-U.S. sales. Theravance retains global rights to revefenacin delivered through other dosage forms (e.g., metered dose inhaler or dry powder inhaler) as well as the rights to nebulized revefenacin in China.
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