Protagonist Therapeutics, Takeda enter into license agreement for Rusfertide

Takeda (TAK) and Protagonist Therapeutics (PTGX) “announced the signing of a worldwide license and collaboration agreement for the development and commercialization of rusfertide, an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin, currently in a pivotal Phase 3 trial, VERIFY, for the treatment of Polycythemia Vera, or PV. PV is a rare chronic blood disorder characterized by excessive production of red blood cells that affects as many as 160,000 patients in the U.S.(i), with a similar prevalence in Europe(ii)(iii). The hallmark manifestations of PV are increased red blood cell count and iron deficiency(iv), putting patients at higher risk of cardiovascular and thrombotic events, such as heart attack and stroke(v)(vi), often impacting quality-of-life with symptoms such as fatigue and confusion(vii). Under the terms of the agreement, Protagonist will receive an upfront payment of $300 million and is eligible to receive additional worldwide development and regulatory milestone payments, as well as commercial milestones and tiered royalties on ex-U.S. net sales. Protagonist will remain responsible for research and development through the completion of the Phase 3 clinical trial and U.S. regulatory approval. Takeda has rights for ex-U.S. development and is responsible for leading global commercialization activities.”