New inhaled therapy for pulmonary hypertension in development
United Therapeutics, Mannkind first worked together on Tyvaso DPI
United Therapeutics and Mannkind Corporation are teaming up to develop a new inhaled therapy for pulmonary hypertension.
The two companies worked together to develop Tyvaso DPI, a dry powder formulation that was approved in the U.S. in 2022 to improve exercise ability in people with pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (PH-ILD).
“Building on the success of Tyvaso DPI, we are proud to deepen our collaboration with United Therapeutics to bring innovative patient-centric inhaled therapies to patients living with pulmonary hypertension,” Michael Castagna, CEO of Mannkind, said in a company press release. “This next step highlights the strength of our partnership and the versatility of our dry powder formulations and inhalation devices in addressing serious respiratory conditions.”
United and Mannkind first entered into a license and collaboration agreement in 2018, which gave United the rights to what would become Tyvaso DPI. Under that deal, United secured the option to develop a second dry powder inhalation therapy.
Developing a new PH therapy
Tyvaso DPI is a formulation of treprostinil, a substance that reduces blood pressure by prompting blood vessels to relax and widen. Along with Tyvaso DPI, United also markets other treprostinil formulations, including inhaled Tyvaso, Orenitram, an oral medication, and Remodulin, which is given by infusion or injection.
All these therapies are approved in the U.S. for PAH, which is marked by high pressure in the blood vessels of the lungs. Tyvaso and Tyvaso DPI also are approved for PH-ILD, where scarring in the lungs leads to high blood pressure in lung blood vessels.
Under the new agreement, Mannkind will use its proprietary drug development platform to create a new inhaled therapy. The company said it plans to start formulation and development activities immediately. Once the therapy has been identified, United will be responsible for its preclinical and clinical development.
As part of the deal, United will pay $5 million up front to Mannkind, with the possibility for up to $35 million if development milestones are met, plus 10% royalties on net sales if the therapy is brought to market.
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