Years after Pfizer passed on a buyout option, AM-Pharma finds a new partner for its kidney drug
A couple of years ago, Pfizer passed on an option to buy out AM-Pharma and its recombinant human alkaline phosphatase for kidney failure on the heels of some mixed Phase II data. Now, the program has attracted a new partner — and an approval could mean a big payout for AM-Pharma.
Tokyo-based Kyowa Kirin is putting down $23.6 million upfront for exclusive development and commercialization rights to ilofotase alfa in Japan. There’s another $148 million in biobucks on the line, adding up to a $290 million deal with “tiered double-digit royalties” and a drug supply fee.
AM-Pharma will be responsible for an ongoing Phase III study, which seeks to enroll up to 1,600 patients with sepsis-associated acute kidney injury and is expected to produce data in 2023. The company’s also on the hook for a Phase I PK, safety and tolerability study in Japan. After that, Kyowa Kirin will take the candidate to regulators.
Sepsis is a life-threatening organ dysfunction that’s caused by an improper host response to infection. The kidney is the most commonly affected organ, resulting in AKI, which occurs in 40% to 60% of critical-care admissions, according to the partners.
Ilofotase alfa works by dephosphorylating substances that can trigger the immune system into devastating the kidney, thus detoxifying them and reducing the inflammation. In a Phase II trial, a 1.6 mg/kg dose showed a 46% relative reduction in mortality compared to the placebo group (p=0.022). However, the drug missed its primary endpoint of improving kidney function in seven days.
“Short term kidney function improvement was really more a design for the Phase II study to be able to pick the most optimal dose,” CEO Erik van den Berg told Endpoints News back in 2019. “It’s kind of a biomarker if you like. For Phase III one has to choose hard clinical endpoints, and the most preferred endpoint by the regulators is the mortality in this setting.”
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 back in 2015. The pharma walked away from the deal following the Phase II readout, citing “internal strategic reasons.” But AM-Pharma pushed on with a Phase III trial anyway, enrolling the first patient in its pivotal REVIVAL study back in November. The trial was planned with the help of a small boost 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.