Takeda is paying Protagonist Therapeutics $300 million upfront to develop and commercialize a late-stage rare hematology asset, inking a pact that gives the California-based biotech the chance to write its own ending.
The main character of this tale is rusfertide, Protagonist’s investigational injectable hepcidin mimetic designed to treat polycythemia vera, a rare chronic blood disorder. The candidate is currently being assessed in a pivotal phase 3 trial dubbed VERIFY.
Rusfertide has had its share of hardships after the FDA yanked a breakthrough designation in 2022, citing “observed malignancies.” But every story needs a good underdog.
The new agreement means Takeda will help Protagonist co-develop and commercialize rusfertide both in the U.S. and globally. While Protagonist is responsible for R&D through the phase 3 trial and potential U.S. regulatory approval, Takeda will hold exclusive rights for all development and commercialization activities outside the U.S.
Takeda is paying Protagonist $300 million within 30 days of the deal closing and will give the company the chance to receive additional worldwide development and regulatory milestone payments as well as milestones and tiered royalties on ex-U.S. sales.
After U.S. regulatory filing, Takeda will launch commercialization activities and give Protagonist the chance to co-detail and split profits 50-50. If Protagonist opts out of the split, the company could receive opt-out payments and higher milestone and royalty payments.
“This transformational deal allows Protagonist to focus on completion of phase 3, while leveraging Takeda’s exceptional global commercialization capabilities to immediately commence pre-commercial activities with a first-in-class new chemical entity,” Protagonist CEO Dinesh Patel, Ph.D., said in a Jan. 31 release. “As we progress towards a fully integrated pharmaceutical company, this deal mitigates the inherent execution risks of a first-time commercial launch, optimizes the timing and enhances the scope for peak potential sales of rusfertide, while still allowing us to actively participate in the commercial experience and economics with a 50:50 profit split in the U.S. market.”
On Takeda’s side, the deal represents a fresh page in the company’s strategy to acquire late-stage assets in the rare disease space, said Julie Kim, president of Takeda’s U.S. business unit and U.S. country head.