Theravance Biopharma and Mylan announced that they have entered into a development and commercialization agreement for TD-4208, a novel nebulized LAMA for the treatment of COPD and other respiratory diseases that is currently in Phase 2 development. Theravance Biopharma will retain the rights to MDI and DPI formulations of the drug.
As part of the deal Mylan will pay $15 million in cash up front and will purchase $30 million worth of shares in Theravance Biopharma at $18.92 per share. Potential development and sales milestones of $220 million are included in the deal; of that $220 million, $45 million would be for potential combination products that would include TD-4208.
According to the announcement, a Phase 3 program for the once-daily inhalation solution is expected to start later this year. Mylan will pay for the US registrational development program, which will be conducted by Theravance Biopharma. If TD-4208 gets FDA approval, the companies will share costs from that point on, and Mylan will manufacture the product and distribute it in the US, with Theravance Biopharma potentially as a co-promoter. Outside the US, Mylan will develop and commercialize the product and will pay Theravance biopharma a royalty on sales. China is excluded from that agreement.
Mylan’s funding of TD-4208 will come at the expense of the development of another Mylan inhalation product, the announcement says: “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.”
Mylan CEO Heather Bresch commented, “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.”
Theravance Biopharma Chairman and CEO Rick E Winningham said, “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 Vibactiv (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. We look forward to working with Mylan to bring this potential first-in-class, once-daily nebulized therapy to COPD patients.”
Read the Theravance Biopharma and Mylan press release.
