Theravance Biopharma, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, central nervous system (CNS)/pain and gastrointestinal (GI) motility dysfunction, has just announced it has partnered with global generic and specialty pharmaceuticals company, Mylan Inc. The two companies will be collaborating on developing and commercializing TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases.
COPD is one of the most common lung diseases and a major cause of morbidity and mortality worldwide, being the third leading cause of death in the United States alone. It is a progressive disease in which individuals develop serious problems in breathing. Smoking is considered to be the leading cause of COPD. Patients with obstruction of the airways, shortness of breath (dyspnea) and acute exacerbations are usually prescribed inhalation therapy with bronchodilators and steroids.
Multiple Phase II clinical studies have demonstrated TD-4208’s favorable top-line findings in patients with COPD, prompting the US Food and Drug Administration to approve Theravance’s Phase III registrational study design, due to begin enrolment in 2015. Both companies are confident the drug will be a best-in-class, once-daily, single-agent, nebulized product for COPD patients who require or prefer nebulized therapy.
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“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.
“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,” 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.”
According to the agreement, Theravance will spearhead the registrational development program in the United States, with Mylan reimbursing the former’s incurred costs, until the FDA’s approval of a New Drug Application. From this point, all costs to get TD-4208 on the market will be shared. Additionally, Mylan will be leading commercial manufacturing.
Both companies will work together to promote the drug, as defined by several profit-sharing terms. In territories outside the US, Mylan will be handling development and commercialization, and subsequently pay Theravance royalties on net sales. The agreement retains Theravance’s international rights to TD-4208 administered through other methods, such as via metered dose inhaler, or dry powder inhaler.
According to the financial terms provided, Theravance will receive an upfront payment of $15 million in cash, and has consented to a $30 million equity investment in ordinary shares worth $18.92 each – equivalent to a 10% premium over the 5-day trailing volume-weighted average price ending January 30. Furthermore, Theravance will receive development and sales milestone payments expected to amount to $220 million, with $45 million reserved for potential combined therapeutics in the future.