Mylan, Theravance ink deal for COPD therapy

GEORGE TOWN, Grand Cayman & PITTSBURGH—Mylan Inc. and Theravance Biopharma Inc. have announced a partnership to develop and, pending U.S. Food and Drug Administration approval, commercialize TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases.

"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 3 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," Rick E Winningham, chairman and CEO of Theravance Biopharma, said in a press release. "We look forward to working with Mylan to bring this potential first-in-class, once-daily nebulized therapy to COPD patients."

Per the agreement, Mylan and Theravance Biopharma will co-develop nebulized TD-4208 for COPD and other respiratory diseases, with Theravance Biopharma leading the U.S. registrational development program while Mylan will be responsible for reimbursing Theravance's costs for that program up until approval of the first new drug application, after which point the costs will be shared. Mylan will also assume responsibility for commercial manufacturing, and will lead commercialization in the U.S., while Theravance Biopharma will retain the right to co-promote the product under a profit-sharing arrangement. Outside of the U.S., excluding China, Mylan will be responsible for development and commercialization, and Theravance will receive a royalty on net sales. Theravance will retain worldwide rights to TD-4208 delivered via other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI).

In addition, Mylan will also make an initial payment to Theravance of $15 million in cash, as well as a $30-million equity investment by purchasing newly issued ordinary shares at $18.92 per share. Theravance is eligible to receive potential development and sales milestone payments totaling $220 million in the aggregate, with $175 million linked to TD-4208 monotherapy and $45 million for future potential combination products.

"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 CEO Heather Bresch.

COPD is the third leading cause of death in the United States, according to the American Lung Association, with some 12.7 million Americans estimated to have COPD in 2011.

SOURCE: Mylan press release