Ralinepag is Arena’s investigational, oral, selective and potent agonist of prostacyclin receptor. The therapeutic is being developed to treat pulmonary arterial hypertension (PAH).
Under the agreement, United Therapeutics will gain exclusive, global rights to develop, manufacture and commercialise the drug candidate.
United Therapeutics chairman and CEO Martine Rothblatt said: “We have conducted extensive due diligence on ralinepag, applying our two decades of knowledge about PAH.
“We are confident that after achieving FDA approval via at least one of its several different potential regulatory pathways to success, this product will help greater than 10,000 patients annually from the 2020s and well into the 2030s, while complementing our existing portfolio of PAH therapies.”
As part of the deal, United will pay $800m upfront to Arena, which is also eligible for potential milestones of up to $400m based on achieving select regulatory events.
In addition, Arena will get double-digit tiered royalties on annual net sales of the drug candidate.
Arena Pharmaceuticals president and CEO Amit Munshi said: “This transaction represents a significant milestone in the development of ralinepag and will strategically position Arena to aggressively advance our best-in-class pipeline, anchored by etrasimod and olorinab, with the focus and resources essential for long-term success.”
Ralinepag had successfully completed a Phase II clinical trial and is currently being evaluated for safety and efficacy in Phase III ADVANCE programme.
The ADVANCE programme consists of Outcomes, Capacity and Endurance trials assessing for time to clinical event (TtCE), peak oxygen uptake (CPET) and six-minute walk distance (6MWD), respectively.