After mulling its options for the past few months, Protagonist Therapeutics has decided to pocket $475 million from Takeda rather than split the U.S. profits for a near-approval hematology asset.
The Japanese pharma paid $300 million back in 2024 to license rusfertide, an injectable hepcidin mimetic designed to treat a rare chronic blood disorder called polycythemia vera (PV). The deal terms included splitting U.S. profits for the drug equally between the two companies. Since then, rusfertide has scored a win in pivotal phase 3 study, leading the companies to submit the drug for FDA approval at the start of this year.
Rusfertide mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. Protagonist has touted the drug as a way for PV patients to reduce or even eliminate the need for regular phlebotomy.
The approval submission Jan. 6 started a window for Protagonist to decide whether to stick with the 50/50 U.S. profit split set out in the original agreement or to opt out.
Protagonist announced Tuesday that it will take the second route. It means the company will get $200 million now, with another $275 million due if the FDA approves rusfertide for PV. The regulator’s decision is expected in the third quarter.
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Even more cash could come Protagonist’s way, with the company eligible for up to $975 million in milestone payments as well as tiered royalties on worldwide net sales ranging from 14% to 29%.
Protagonist’s decision won’t have come as a surprise to Takeda. The California biopharma disclosed as far back as February that it expected to go down the opt-out route.
“Exercising our opt-out right reflects our conviction in rusfertide and secures what we believe is the most attractive risk-adjusted value outcome for Protagonist and its shareholders as the hepcidin mimetic peptide approaches a potential approval,” Protagonist CEO Dinesh Patel, Ph.D., said in an April 28 release.
“This election provides meaningful near-term non-dilutive cash, materially enhances our long-term economic participation through milestones and worldwide royalties, and further strengthens our ability to invest in our broader pipeline and return value to shareholders,” Patel added. “We value our partnership with Takeda and believe they are exceptionally well-positioned to maximize the global opportunity for rusfertide.”
