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news.Theravance Biopharma and Mylan are set to jointly develop and commercialize a new investigational once-daily nebulized long-acting muscarinic antagonist (LAMA), TD-4208, to treat chronic obstructive pulmonary disease (COPD) and other respiratory diseases.
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In multiple Phase II trials, TD-4208 has shown positive top-line results in COPD patients, and recently the FDA had agreed to the design of the Phase III registrational program that is scheduled to begin in 2015.
According to the firms, TD-4208 has the potential to be a best-in-class once-daily single-agent nebulized product for COPD patients who require, or prefer, nebulized therapy.
As part of the deal, Theravance will lead the US registrational development program, while Mylan will be responsible for reimbursement of Theravance’s costs for that program up until the approval of the first new drug application (NDA), after which costs will be shared.
Additionally, Mylan will be responsible for commercial manufacturing of the product.
In the US, Mylan will lead commercialization and Theravance will retain the right to co-promote the product under a profit-sharing arrangement.
Outside the US (excluding China), Mylan will be responsible for the product’s development and commercialization and pay Theravance a royalty on net sales.
Theravance retains worldwide rights to TD-4208 delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI).
Apart from funding the US registrational development program, Mylan will pay Theravance an initial payment of $15m in cash and has agreed to make a $30m equity investment by purchasing newly issued Ordinary Shares at a price of $18.92 per share.
Under the deal, Theravance is eligible to receive potential development and sales milestone payments totaling $220m in the aggregate, with $175m associated with TD-4208 monotherapy and $45m for future potential combination products.