Takeda has entered a global licence and partnership agreement with Protagonist Therapeutics to develop and market rusfertide.

Rusfertide is an investigational injectable hepcidin mimetic peptide that mimics the natural hormone hepcidin. It is a potential treatment for polycythemia vera, a rare chronic blood disorder.

The asset is designed to normalise iron homeostasis and manage iron absorption, storage and distribution within the body.

Protagonist is eligible to receive $300m as an upfront payment from Takeda.

Takeda will also make global development, regulatory and commercial milestone payments, apart from royalty payments on net product sales outside the US, to Protagonist.

Protagonist retains responsibility for research and development up to the completion of the Phase III clinical trial and regulatory approval in the US.

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Takeda will manage the development of the asset outside the US and lead international commercialisation efforts.

Following US regulatory submission, the company will spearhead rusfertide’s marketing, with Protagonist holding an option to co-detail in the US market.

Protagonist may opt out of a 50:50 profit share arrangement. If they choose this path, they will receive opt-out payments, milestone payments and royalties. Takeda would retain full rights outside the US in both scenarios.

Rusfertide is undergoing a Phase III trial dubbed VERIFY.

The Phase II REVIVE trial results have shown promising outcomes, with the primary endpoint achieved in the randomised section.

Long-term follow-up results from the two-year, open-label extension indicated sustained hematocrit control, reduced need for phlebotomy and durable tolerability without any new safety concerns.

The new partnership leverages Takeda’s expertise in rare haematology, highlighted by the recent US Food and Drug Administration (FDA) approval of ADZYNMA for congenital thrombotic thrombocytopenic purpura.

Takeda US business unit president and country head Julie Kim stated: “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.”

The development comes after the US FDA approved Takeda’s GAMMAGARD LIQUID for chronic inflammatory demyelinating polyneuropathy in adults.