Silver Spring-based United Therapeutics Corp. announced Tuesday that it will pay a California company $95 million to develop a new form and delivery method of its flagship Remodulin drug to treat pulmonary arterial hypertension.
United Therapeutics (NASDAQ: UTHR) is licensing a dry powder formulation of treprostinil, the active ingredient in Remodulin, in development by MannKind Corp. (NASDAQ: MNKD). The system is currently in the clinical trials stage.
The deal will expand the delivery methods for Remodulin, now available in intravenous, injectable and oral forms.
United Therapeutics will be responsible for the global development, regulatory and commercial activities of the drug's new form.
Westlake Village, California-based MannKind will manufacture clinical supplies and initial commercial supplies out of its Danbury, Connecticut, plant, while United Therapeutics will manufacture long-term commercial supplies of the product.
The deal provides for a $45 million upfront payment to MannKind and potential payments of another $50 million, dependent on certain development targets. MannKind will also be eligible for “low double-digit royalties” on net sales of the product, per a release. The announcement sent MannKind stock surging more than 40 percent in early morning trading. United Therapeutics was down about 2.5 percent.
United Therapeutics has a long history with treprostinil and MannKind. Exactly 21 years ago, UT CEO Martine Rothblatt said in a statement, the Maryland company combined one of its creations with a parenteral infusion pump called MiniMed 407c, invented by Alfred Mann, to create Remodulin.
Rothblatt said the new inhalation devices will be "revolutionary."
In late July, United Therapeutics received Federal Drug Administration approval for an implantable pump for Remodulin. The drug, perhaps soon-to-be-available as a generic, generated sales of $286.3 million in the first six months of the year for United Therapeutics.
The deal extends beyond treprostinil. MannKind granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension — subject to an additional $40 million payment per license. And the California company will get another $10 million immediately to conduct research “on behalf of United Therapeutics for products outside the scope of the licensing and collaboration agreement.”
Under the deal with MannKind Corp., Silver Spring's United Therapeutics will be responsible for global development, regulatory and commercial activities for the dry power formulation and inhalation delivery of treprostinil, the active ingredient in United Therapeutics' flagship product Remodulin.