Theravance Biopharma Inc and Mylan Inc have announced a partnership for the development and commercialization of respiratory disease drug TD-4208. The drug is an investigational once daily-nebulized long-acting muscarinic antagonist (LAMA) for COPD and other respiratory diseases, according to RTT News.
Under the terms of the agreement, RTT News reports that Theravance will lead the US registrational development program and Mylan will be liable for reimbursement of costs until approval of the first new drug application. In addition, Mylan will be responsible for commercial manufacturing of TD-4208.
According to Mylan, once-daily LAMAs are currently used in maintenance therapy for patients with COPD, but available only in handheld devices. TD-4208 has shown positive top-line results in COPD patients in multiple Phase 2 studies, the Phase 3 registrational program might be started this year, as indicated on the RTT News report.
The RTT News report notes that Mylan has agreed to pay $15 million in cash and a $30 million equity investment in Theravance Biopharma by purchasing newly issued Ordinary Shares at a price of $18,92 per share. Theravance Biopharma will be eligible to receive possible milestone payments of $220 million in the aggregate, with $175 million associated with TD-4208 monotherapy and $45 million for future potential combination products.
Source: RTT News