Arena Pharmaceuticals and United Therapeutics Corporation announced that the companies have entered into a global license agreement for Arena’s Phase 3 investigational drug candidate, Ralinepag, a next-generation, oral, selective, and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH).

Under the terms of the agreement, Arena will grant United Therapeutics exclusive, worldwide rights to develop, manufacture, and commercialize Ralinepag. In return, Arena will receive up to $1.2 billion, including an upfront payment of $800 million and potential milestone payments totaling up to $400 million based on the achievement of certain regulatory events. Additionally, Arena will receive low double-digit tiered royalties on annual net sales of Ralinepag.

“We believe Ralinepag has the potential to transform the treatment of PAH,” said Amit D. Munshi, president and CEO of Arena. “We are thrilled to partner with United Therapeutics, based on their long-standing, deep commitment to the PAH community. 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.”

“We are very impressed with the clinical development plan and FDA coordination being managed by Arena,” said Martine Rothblatt, Ph.D., chairman and CEO of United Therapeutics. “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.”

(Source: Arena Pharmaceuticals, Inc.)