Mylan, Theravance Biopharma Partner Up for $265 Million COPD Pact
Published: Feb 02, 2015
February 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Pittsburgh, Penn.-based Mylan Pharmaceuticals, Inc. announced today that it will partner with George Town, Grand Cayman-based Theravance Biopharma, Inc. on the development and commercialization of TD-4208 for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory illnesses.
TD-4208 is a once-daily nebulized long-acting muscarinic antagonist (LAMA). The compound has shown positive results in COPD patients in several Phase II studies. The U.S. Food and Drug Administration (FDA) recently granted approval to a Phase III registrational program expected to start this year.
“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,” said Heather Bresch, chief executive of Mylan in a statement. “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.”
Mylan has been very busy with acquisitions and partnerships in just the last couple weeks. The company also announced today that it will be acquiring certain business units of Mumbai, India-based Famy Care Limited, a specialty women’s health care company. The company also announced on Jan. 29, 2015 that it has approved the acquisition of Abbott Laboratories ’s non-U.S. developed markets specialty and branded generics business, which will involve a reorganization in the Netherlands.
The Theravance agreement has the two companies co-developing TD-4208 for COPD and other respiratory illnesses. Theravance will head the U.S. registrational development program. Mylan will handle reimbursement of Theravance’s costs up to the point of approval of the first new drug application. After that point costs will be shared.
Mylan will handle commercialization and manufacturing. In the U.S., Mylan will direct commercialization of the product and Theravance holds the right to co-promote the drug under a profit-sharing deal. In the rest of the world, except for the U.S. and China, Mylan will be in charge of development and commercialization, paying Theravance royalties on net sales. Theravance will retain global rights to TD-4208 for alternate dosage forms and delivery systems.
“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),” said Rick Winningham, chairman and chief executive of Theravance in a statement. “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.”