United Therapeutics Amends Agreement With Arena Pharmaceuticals, Pfizer Subsidiary, Eliminating All Royalty Obligations Under Its Exclusive License Agreement Related to Ralinepag for an Upfront Payment of $525M
Benzinga Newsdesk 7 hours ago
Health CareGeneralBiotech
This transaction demonstrates our confidence in the revenue opportunity for oral ralinepag, which has a pending new drug application under review by the FDA for pulmonary arterial hypertension, as well as the new dry
This transaction demonstrates our confidence in the revenue opportunity for oral ralinepag, which has a pending new drug application under review by the FDA for pulmonary arterial hypertension, as well as the new dry powder inhalation formulation we are developing for a variety of pulmonary indications," said James Edgemond, Chief Financial Officer and Treasurer of United Therapeutics. "Ralinepag has the potential to bring substantial benefits to large patient populations spanning a number of difficult-to-treat conditions, and we expect it will transform our company in the process."
United Therapeutics has a new drug application (NDA) under review by the U.S. Food and Drug Administration (FDA) as a once-daily, oral form of ralinepag for the treatment of pulmonary arterial hypertension (PAH), with a user fee action date of June 24, 2027. The company is also developing an inhaled version of ralinepag utilizing the dry powder inhalation (DPI) technology licensed from MannKind Corp., and plans to study ralinepag DPI for one or more of the following indications: pulmonary hypertension associated with interstitial lung disease (PH-ILD), idiopathic pulmonary fibrosis (IPF), and progressive pulmonary fibrosis (PPF).
United Therapeutics acquired the rights to ralinepag in 2018 under an exclusive license agreement with Arena which was later acquired by Pfizer Inc. The agreement provided for a low double-digit royalty on United Therapeutics’ net sales of all formulations of ralinepag. Under the license agreement, United Therapeutics will remain obligated to make the following milestone payments to Arena: (1) a one-time payment of $250.0 million for the first, if any, marketing approval in the United States for an inhaled version of ralinepag to treat PAH; (2) a one-time payment of $150.0 million for the first, if any, marketing approval in any of Japan, France, Italy, the United Kingdom, Spain, or Germany for an oral version of ralinepag to treat any indication.
Ralinepag is an investigational-stage product not approved in any jurisdiction for any indication.