Takeda and Protagonist Therapeutics have entered into a worldwide license and collaboration agreement worth over $300m to develop and commercialise an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin to treat polycythaemia vera (PV).
The treatment, rusfertide, is currently being evaluated in a phase 3 clinical trial, VERIFY.
Under the terms of the agreement, Protagonist will receive an upfront payment of $300m and will be eligible to receive additional worldwide development and regulatory milestone payments, as well as commercial milestones and tiered royalties on US net sales.
As part of the deal, Protagonist will continue to be responsible for the research and development of rusfertide through the completion of the VERIFY trial and US regulatory approval.
Takeda will gain the rights to the ex-US development of rusfertide and will be responsible for leading global commercialisation activities.
Following regulatory approval from the US Food and Drug Administration, Protagonist will have the option to co-detail in the US and would be eligible to receive opt-out payments as well as enhanced milestone and royalty payments, while Takeda would maintain full US rights.
Affecting around 160,000 patients in the US, PV is a rare chronic blood disorder which is caused by an excessive production of red blood cells.
Julie Kim, president, US business unit and US country head, Takeda, said that the agreement will help “to deliver a first-in-class therapy to PV patients, helping to address significant needs in the community”.
Rusfertide works to regulate iron homeostasis and control the absorption, storage and disruption of iron in the body.
The treatment for PV achieved its primary endpoint in the phase 2 REVIVE study, which showed durable haematocrit control, decreased phlebotomy use, long-term tolerability and no new safety signals in patients living with PV.
Dinesh Patel, president and chief executive officer, Protagonist, said: “This.. deal allows Protagonist to focus on [the] 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.”
Most recently, Takeda’s maintenance therapy, HyQvia, received approval from the European Commission to treat rare neuromuscular disorder chronic inflammatory demyelinating polyneuropathy.