Arena Scores $800 Million Upfront in Deal with United Therapeutics for PAH Drug

Rare Daily Staff

Arena Pharmaceuticals entered into a global license agreement with United Therapeutics for Arena’s late-stage experimental drug ralinepag for the treatment of pulmonary arterial hypertension worth up to $1.2 billion.

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 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.

Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure and reduce life expectancy. The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress despite treatment.

Ralinepag is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of PAH. The company said ralinepag’s potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH.

“We believe ralinepag has the potential to transform the treatment of PAH,” said Amit 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.”

The effectiveness of the agreement is conditioned on expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.

“We have conducted extensive due diligence on ralinepag, applying our two decades of knowledge about PAH,” said Martine Rothblatt, chairman and CEO of United Therapeutics. “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.”

November 16, 2018
Photo: Amit Munshi, president and CEO of Arena