Mylan Partners with Theravance to Develop an Investigational Treatment for COPD

Mylan announced that it has entered a partnership for a novel COPD treatment with Theravance Biopharma, a biopharmaceutical company focused on the discovery, development, and commercialization of small-molecule medicines for therapeutic treatments in respiratory disease, bacterial infections, central nervous system pain, and gastrointestinal motility dysfunction. As part of the partnership, the companies will develop and commercialize (pending FDA approval) TD-4208, a novel investigational treatment for chronic obstructive pulmonary disease (COPD).

The treatment, which is a nebulized long-acting muscarinic antagonist (LAMA), showed positive results during Phase II studies resulting in FDA approval for the design of the Phase III program. The once a day, single-agent product will be developed for COPD, as well as other respiratory diseases.

Mylan will pay Theravance $15 million in cash with an additional $30 million in equity investment by purchasing newly issued ordinary shares at $18.92 per share. Theravance could also receive up to $220 million in sales milestones payments, with $175 million associated with TD-4208 monotherapy and $45 million for future potential combination products.

Umer Raffat of Evercore ISI said in an analyst note that there are several LAMAs on the market, however there aren’t any nebulized forms available. Nebulizers are designed for patients that may have difficulties using typical inhalation devices, such as the elderly or young children. Raffat continued by explaining that the introduction of this novel drug could be substantial. Utilization of the nebulized form of drugs is approximately 9–10%, with an existing hand-held LAMA (Spiriva) doing approximately $5 billion in sales. A potential competitor not yet on the market is Sunovion’s twice a day nebulized LAMA, Sun-101 (glycopyrronium). However, Raffat comments that unlike Theravance’s TD-4208, which can be used in any nebulizer, Sun-101 has a nebulizer that is product-specific.

Source: Mylan