Theravance, Mylan in COPD Development Pact

Theravance Biopharma, Inc. and Mylan Inc. have partnered for the development and commercialization of TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases. TD-4208 has shown positive results in COPD in multiple Phase II studies, and the design of the Phase III registrational program is underway and anticipated to begin this year.

Theravance will lead the U.S. registrational development program and Mylan will be responsible for costs for the program up until the approval of the first new drug application, after which costs will be shared. Mylan will be responsible for commercial manufacturing and will lead commercialization in the U.S. Theravance will retain the right to co-promote the product under a profit-sharing arrangement. Outside the U.S. (excluding China), Mylan will be responsible for development and commercialization and will pay Theravance a royalty on sales.

“This exciting development and commercialization collaboration leverages Mylan’s expertise in manufacturing and marketing complex respiratory products and Theravance Biopharma’s respiratory clinical development capabilities. The addition of TD-4208 to our pipeline is highly complementary with our existing respiratory portfolio, including our marketed nebulized COPD product, Perforomist Inhalation Solution, and reinforces Mylan’s leadership in nebulized respiratory therapy,” said Mylan chief executive officer Heather Bresch.

“Partnering with a world leader in nebulized respiratory therapies enables us to expand the breadth of our TD-4208 development program and extend our commercial reach beyond the acute care setting where we currently market VIBATIV (telavancin). Funding of the Phase III registrational program by Mylan strengthens our company’s capital position and enhances our financial flexibility to advance other high-value pipeline assets alongside TD-4208,” said Rick E Winningham, chairman and chief executive officer, Theravance Biopharma. “We look forward to working with Mylan to bring this potential first-in-class, once-daily nebulized therapy to COPD patients.”