The therapy is currently being evaluated in the REVIVAL Phase III clinical study as a potential disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI)
AM-Pharma, a developer of therapeutics for severe conditions, and Kyowa Kirin, a global specialty pharmaceutical company, have entered into an exclusive license agreement under which Kyowa will gain the rights to develop and commercialise ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. It’s currently being evaluated in the REVIVAL Phase III clinical study as a potential disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI). In July of this year, AM-Pharma announced the enrolment of the first patient in Japan as part of the trial.
“Kyowa Kirin is a leading Japanese specialty pharmaceutical company deeply rooted in science that shares our commitment to addressing high unmet medical needs. Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialisation of ilofotase alfa in Japan,” stated Erik van den Berg, CEO at AM-Pharma. “This is a significant milestone for AM-Pharma as this agreement will optimise the commercialisation of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.”
“As an organisation centred around research, development and partnerships with innovative drug discovery organisations around the globe, we are excited to initiate this relationship with AM-Pharma to potentially improve the lives of patients and families affected by sepsis-associated acute kidney injury,” added Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. “Ilofotase alfa has demonstrated its therapeutic potential in AM-Pharma’s Phase II STOP-AKI study, and we look forward to being a strategic partner supporting the commercialisation and thereby patient access of ilofotase alfa upon successful completion of the pivotal REVIVAL study.”
Under the terms of the agreement, AM-Pharma will receive €20m ($23.5m) upfront payment, and €30m ($35.3m) related to milestones prior to regulatory submission, and up to €195m ($229.7m) upon submission, NHI price listing and sales milestone payments. Kyowa will gain the exclusive right to develop and commercialise the therapy in Japan. AM-Pharma is responsible for the completion of the REVIVAL study as well as a Phase I pharmacokinetics, safety and tolerability study in Japan and drug supply, whereas Kyowa will be responsible for the therapy’s regulatory approval process and commercialisation in Japan.