A few years ago, Pfizer passed on an option to buy back AM-Pharma and its recombinant human alkaline phosphatase for kidney failure following some mixed Phase II data. Now the program has attracted a new partner – and an approval could mean a big win for AM-Pharma.
Tokyo-based Kyowa Kirin is investing $ 23.6 million initially for the exclusive rights to develop and commercialize ilofotase alfa in Japan. There’s still $ 148 million in biobucks at stake, which is a $ 290 million deal with “double-digit tiered royalties” and drug procurement fees.
AM-Pharma will be responsible for an ongoing Phase III study, which aims to enroll up to 1,600 patients with acute renal failure associated with sepsis and is expected to produce data in 2023. The company is also on the cusp of to obtain a phase I PK, safety and tolerance study in Japan. After that, Kyowa Kirin will bring the candidate to the regulators.
Sepsis is a potentially fatal organ dysfunction that is caused by an inappropriate host response to infection. The kidney is the most frequently affected organ, leading to ARI, which occurs in 40 to 60% of intensive care admissions, according to partners.
Ilofotase alfa works by dephosphorylating substances that can trigger the immune system by devastating the kidneys, thereby detoxifying them and reducing inflammation. In a phase II trial, a dose of 1.6 mg / kg showed a relative reduction in mortality of 46% compared to the placebo group (p = 0.022). However, the drug missed its primary endpoint of improving kidney function in seven days.
“Short-term improvement in kidney function was actually more of a design for the Phase II study so that the most optimal dose could be chosen,” said CEO Erik van den Berg. Terminal news in 2019. “It’s kind of a biomarker if you will. For phase III, strict clinical endpoints must be chosen, and the endpoint preferred by regulators is mortality in this context. “
Pfizer had paid $ 87.5 million for a minority stake in AM-Pharma and an exclusive option to buy out the rest of the company in 2015. The pharmaceutical company withdrew from the deal after reading Phase II, citing “internal strategic reasons”. But AM-Pharma still continued a phase III trial, enrolling the first patient in its pivotal REVIVAL study in November. The trial was planned with a little help from Cowen Healthcare Investments and a loan from the European Investment Bank last March.
“Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan,” van den Berg said of Kyowa Kirin in a statement.