AM-Pharma Partners with Kyowa Kirin in $289m Deal for Kidney Drug

AM-Pharma is really committed to its drug, ilofotase alfa, which has shown promise in treating the highly fatal sepsis-related acute kidney injury (AKI). The Netherlands-based company and its drug candidate were on Pfizer’s menu back in 2015, until the drug giant lost its appetite following a mixed Phase 2 trial.

While the recombinant alkaline phosphatase drug did improve kidney function and survival over the study’s 28-day period, the primary endpoint required it to show benefit within a week, which it didn’t. Unconvinced, Pfizer walked away from the acquisition in 2018.

AM-Pharma though did not lose hope in its drug and forged ahead with plans for a global Phase 3 trial dubbed REVIVAL. The company attracted $131 million in a 2019 funding round co-led by LSP and Andera Partners, with support from a bevy of European investors, new and old. The REVIVAL study began in 2020 and will enroll 1,600 patients in North America, Europe, and Japan.

Two years later, AM-Pharma is rejoicing after signing a deal with Kyowa Kirin bagging a chance to earn in excess of $289 million.

The Deal: $23M Upfront, $266M In Biobucks

AM-Pharma will receive a $23 million payment upfront and stands to gain up to $35.5 million in milestone payments. Most of the money ($230.5 million) will flow only after the drug is submitted, the NHI price listed, and sales milestones are achieved. The deal gives the company the right to charge a drug supply fee and reap double-digit royalties on sales.

AM-Pharma though will need to complete their REVIVAL trial. Data on the trial’s primary endpoint — reducing mortality within 28 days — is expected to roll in by August 2023. They are also tasked with conducting a Phase I trial to test the drug dosage and safety in Japan and supplying the drug.

Kyowa Kirin will gain exclusive rights to develop and commercialize ilofotase alfa in Japan. They will also be in charge of securing regulatory approval for sales of the drug in Japan.

Sepsis-related AKI: An Unaddressed Market

Acute kidney injury (AKI) involves kidney inflammation, which could cause complete loss of renal function. It is a common complication in hospitalized patients. Every year, it affects around 3 million across the US, Europe, and Japan and causes the deaths of roughly 700,000. In the US alone, hospitals spend $10 billion every year trying to manage the condition.

When sepsis (an extreme reaction of the body to infection) triggers AKI, outcomes for patients drop. To date, there is no effective treatment for sepsis-related AKI.

Looking at the unmet need in this area, Kyowa Kirin must have seen potential in AM-Pharma’s drug. The Tokyo-based company has partnered with other firms to deliver drugs to treat a range of kidney diseases, but none were indicated for sepsis-related AKI until now.

Last week in the US, Sentien Biotechnologies announced a partnership with Biomedical Advanced Research and Development Authority (BARDA) to push a Phase 1/2 trial of SBI-101 to treat patients with sepsis-related AKI.

Author

Joy Lin

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