United Therapeutics will pay Samumed $10 million up front and up to $340 million in milestones, plus royalties, for North American rights to Samumed’s SM04646, a Wnt signaling pathway inhibitor that in in Phase 1 development for the treatment of idiopathic pulmonary fibrosis (IPF).
A United Therapeutics subsidiary, Lung Biotechnology PBC, will take over and pay for all future US and Canadian development, regulatory, and commercialization activities.
In July 2017, Samumed reported positive Phase 1 results for SM04646. The FDA granted SM04646 orphan drug designation that same month.
Samumed CEO Osman Kibar said, “We are excited to partner with United Therapeutics because of its culture of integrity, level of commitment, and expertise in pulmonology and drug-device combinations. We look forward to delivering what could be a first-in-class, disease-modifying treatment option for IPF patients.”
Lung Biotechnology PBC Chairman and CEO Martine Rothblatt commented, “I’ve been impressed with Samumed’s exhaustive work on the pleiotropic Wnt pathway from the time I met Dr. Kibar at this year’s Cura Foundation conference on regenerative medicine, held at the Vatican. Our months of due diligence have energized our belief in SM04646’s fibrosis-modulating properties, and hence unique potential for addressing IPF.”
Read the United Therapeutics and Samumed press release.