RESEARCH TRIANGLE PARK – United Therapeutics today announced that the life science firm  will enter into a global licensing and collaboration agreement to develop and commercialize a dry powder formulation of treprostinil, an investigational product currently under evaluation in clinical trials that will treat pulmonary arterial hypertension, with MannKind Corporation.

The deal is worth as much as $105 million.

“We are excited to partner with United Therapeutics, a company that shares our passionate focus on changing patients’ lives,” said Michael Castagna, CEO of MannKind in a press release.

Pulmonary arterial hypertension occurs when there is increased pressure in the vessels, caused by an obstruction in the small arteries in the lung, for a variety of reasons. In many cases of pulmonary arterial hypertension, according to the American Lung Association, the cause is unknown; other causes can be drug-related, HIV infection, connective tissue/autoimmune disorders, and others.

The partnership is exclusive collaboration agreement, and United Therapeutics could pay MannKind as much as $105 million, with $45 million in up front payments once the deal is approved.

Terms of the deal

United Therapeutics said it will be responsible for the global development, regulatory, and commercial activities. MannKind will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Danbury, Connecticut. Long-term commercial supplies will be manufactured by United Therapeutics.

Under the terms of the agreement, MannKind will receive $45 million in up front costs from United Therapeutics, and potential milestone payments of up to $50 million, conditional upon the achievement of specific developmental targets that neither company has shared publicly. The companies also reached an agreement for research by MannKind on behalf of United Therapeutics for products that are otherwise outside of the scope of the licensing and collaboration agreement, with MannKind receiving an immediate payout of $10 million.

MannKind is also expected to receive double-digit royalties of net sales on the product, which will treat high blood pressure in the lungs. Further, MannKind has granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension, with each optioned product subject to a distribution payment to MannKind for up to $40 million in additional option exercise and milestone payments and royalty of net sales.

The licensing deal is a “a further step toward a next generation of treprostinil drug-device systems that enhance options for patients, their families and their prescribers,” according to Martine Rothblatt, chairman and CEO of United Therapeutics. The company is focused on moving into the “second generation” of products, said Rothblatt in a statement.

Treprostinil (marketed under the trade names Remodulin for infusion, Orenitram for oral, and Tyvaso for inhalation) is a vasodilator that is used for the treatment of pulmonary arterial hypertension, according to Wikipedia.

 United Therapeutics’ busy year

This deal comes on the heels of United Therapeutics receiving approval from the United States Food and Drug Administration (FDA) for the use of Remodulin injection in its implantable system for treating pulmonary arterial hypertension in late July.

The company is based in Silver Spring, Maryland, with a large facility in Research Triangle Park. Earlier in the year, United Therapeutics acquired SteadyMed, whose lead product is Trevyent, a combination drug-device that combines PatchPump technology with Treprostinil.

Treprostinil is also marketed under the trade names Remodulin (for infusion), Orenitram (oral), and Tyvaso (for inhalation). The treatment is a synthetic analog of prostacyclin and is a vasodilator that is used for the treatment of pulmonary arterial hypertension.

With the new license agreement, the acquisition, and the recent approval from the FDA, the company is primed to treat pulmonary arterial hypertension. “We are extremely excited to offer this new option to patients suffering from PAH,” said Rothblatt.