Rusfertide is an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin, which is currently in the Phase 3 VERIFY trial for PV treatment, a rare chronic blood disorder
Takeda’s global hub in Cambridge, Massachusetts, US. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has entered into a worldwide license and collaboration agreement with Protagonist Therapeutics for the latter’s late-stage rare haematology asset, rusfertide, for an upfront payment of $300m.
Rusfertide is an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin.
Currently, the asset is in the Phase 3 VERIFY trial for the treatment of polycythemia vera (PV), a rare chronic blood disorder.
According to the terms of the agreement, Protagonist Therapeutics will be eligible to get additional global development and regulatory milestone payments, along with commercial milestones and tiered royalties on ex-US net sales.
Protagonist Therapeutics will continue to be responsible for research and development until the Phase 3 clinical trial is finished and receipt of regulatory approval in the US.
Takeda will oversee the international commercialisation efforts and holds rights to development outside the US.
Furthermore, the Japanese pharma firm will lead the commercialisation of rusfertide after the US regulatory filing, with Protagonist Therapeutics holding the option to co-detail in the US.
Additionally, Protagonist Therapeutics may choose not to participate in the 50:50 profit split as stipulated in the terms of the agreement.
The company will then be entitled to increased milestone and royalty payments as well as opt-out payments. Either way, Takeda would still have full ex-US rights.
Takeda US business unit president and US country head Julie Kim said: “The agreement with Protagonist represents an important step forward in our strategy of acquiring late-stage assets in the rare disease space to leverage our existing infrastructure and expertise.
“It combines the strength of their science with the reach of our commercial organisation, understanding of rare diseases, and most importantly, our focus on supporting patients through their journey.”
Rusfertide was discovered using Protagonist Therapeutics’ peptide technology platform. Its mode of action is expected to regulate iron homeostasis and control the absorption, storage, and distribution of iron in the body, according to Takeda.
The randomised part of the Phase 2 REVIVE study of rusfertide in polycythemia vera met its primary endpoint.
Protagonist Therapeutics president and CEO Dinesh Patel said: “This transformational deal allows Protagonist to focus on completion of Phase 3, while leveraging Takeda’s exceptional global commercialisation capabilities to immediately commence pre-commercial activities with a first-in-class new chemical entity.”