Mylan, Theravance Partner for New COPD DrugBy
Mylan Inc. and Theravance Biopharma, Inc. have formed a partnership for the development and, subject to US Food and Drug Administration approval, commercialization of TD-4208, an investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases.
Under the agreement, Mylan and Theravance Biopharma will co-develop nebulized TD-4208 for COPD and other respiratory diseases. Theravance Biopharma will lead the US registrational development program, and Mylan will be responsible for reimbursement of Theravance Biopharma’s costs for that program up until the approval of the first new drug application, after which costs will be shared. In addition, Mylan will be responsible for commercial manufacturing. In the US, Mylan will lead commercialization, and Theravance Biopharma will retain the right to co-promote the product under a profit-sharing arrangement. Outside the US (excluding China), Mylan will be responsible for development and commercialization and pay Theravance Biopharma a royalty on net sales. Theravance Biopharma retains worldwide rights to TD-4208 delivered through other dosage forms, such as a metered-dose inhaler or dry-powder inhaler (MDI/DPI).
In addition to funding the US registrational development program, Mylan will pay Theravance Biopharma an initial payment of $15 million in cash and has agreed to make a $30 million equity investment in Theravance Biopharma by purchasing newly issued ordinary Shares at a price of $18.92 per share. Under the agreement, Theravance Biopharma is eligible to receive potential development and sales milestone payments totaling $220 million in the aggregate, with $175 million associated with TD-4208 monotherapy and $45 million for future potential combination products.
Mylan and Theravance Biopharma said that they believe that TD-4208 has the potential to be the only FDA-approved once-daily nebulized LAMA product for COPD patients in the near term and that it may offer longer-term opportunities for combination with other nebulized products. In addition, the patent portfolio for TD-4208 is currently expected to provide a TD-4208 nebulized product with exclusivity in the US until at least 2025, which does not include any potential patent-term extensions. “Given the short- and long-term potential of this differentiated product, and in an effort to optimize its uses of capital, Mylan has decided to redeploy resources from the development of its combination nebulized ICS/LABA product (Combo) to TD-4208,” said Mylan in a statement.