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§ Private Profile · Bunnik, The Netherlands
Clinical-stage biopharmaceutical company developing ilofotase alfa for acute kidney injury and severe inflammatory conditions.
AM Pharma has raised $499.5M across 9 funding rounds.
Key people at AM Pharma.
AM Pharma has raised $499.5M in total across 9 funding rounds.
AM-Pharma is a clinical-stage biopharmaceutical company based in Utrecht, Netherlands, that develops recombinant human alkaline phosphatase therapeutics for severe inflammatory conditions and acute kidney injury. The organization's lead candidate, ilofotase alfa, targets life-threatening medical conditions with high mortality rates, such as sepsis-associated acute kidney injury and cardiac surgery-associated renal damage. To support its late-stage clinical trials and ongoing research and development efforts, the enterprise has successfully raised over €250 million in total funding, which includes a €116 million financing round in 2019. The company is backed by a syndicate of corporate and venture capital investors, featuring recognizable institutional names such as Pfizer, Forbion, Gilde Healthcare, and the European Investment Bank. Following a strategic realignment after its Phase III clinical trial results, the firm is currently led by Chief Executive Officer Juliane Bernholz. AM-Pharma was founded in 2001.
AM Pharma has raised $499.5M across 9 funding rounds. Most recently, it raised $51.7M Debt / Other Equity in March 2020.
Key people at AM Pharma.
AM Pharma has raised $499.5M in total across 9 funding rounds.
AM Pharma's investors include Tim Anderson, European Investment Bank, Andera Partners, Forbion, Kurma Partners, Polaris Partners, Ysios Capital, Raphael WISNIEWSKI, martijn kleijwegt, Geert Jan Mulder, Idinvest Partners, Rémi Droller.
AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human alkaline phosphatase therapies, primarily ilofotase alfa, to treat acute kidney injury (AKI) in critical conditions like cardiac surgery-associated renal damage (CSA-RD, affecting 40% of cardiac surgeries), sepsis-associated AKI (SA-AKI), and the rare disease hypophosphatasia (HPP).[1][5][2] The company serves patients with severe organ injuries, healthcare providers, and hospitals facing high unmet needs in renal protection, where no approved preventive treatments exist despite billions in annual care costs.[1][4][5] Ilotase alfa has shown safety in trials with over 1,000 subjects, reno-protective effects, and potential as an enzyme replacement therapy, with recent completion of the Phase III REVIVAL trial for SA-AKI signaling strong growth momentum toward potential approval.[1][5]
Founded in 2001 and headquartered in Utrecht, the Netherlands, AM-Pharma began by developing a bovine form of alkaline phosphatase, successfully tested in Phase II trials for sepsis, AKI, and ulcerative colitis.[1][4] The company evolved to its proprietary fully human recombinant version, ilofotase alfa (recAP), after demonstrating its clean safety profile and favorable pharmacology in Phase I studies.[1][4] Key early traction included adaptive Phase II trials in SA-AKI with 301 patients, positive outcomes on renal function, and strategic funding from investors like LSP (led by Managing Partner Martijn Kleijwegt, involved in prior biotech exits) and partnerships such as with Kyowa Kirin and a minority investment from Pfizer granting purchase options.[2][7] This progression from startup to clinical-stage firm highlights expertise in AKI mechanisms and regulatory navigation.[2]
AM-Pharma rides the wave of precision biologics for critical care, targeting AKI—a leading hospital complication with no preventive drugs amid rising cardiac surgeries and sepsis cases driven by aging populations and post-pandemic organ failures.[1][4][5] Timing aligns with regulatory emphasis on adaptive trials and enzyme therapies, as seen in REVIVAL's design following feedback, amid a $10B+ US AKI care market hungry for interventions.[2][4][5] Market forces like biotech funding for rare diseases (HPP) and high-need AKI favor its progress, influencing the ecosystem by validating alkaline phosphatase as a novel detoxifying mechanism, potentially enabling follow-on indications and inspiring human-recombinant enzyme platforms in nephrology and beyond.[2][5][6]
With Phase III REVIVAL completed, AM-Pharma is primed for data readout, regulatory filings, and potential commercialization of ilofotase alfa in SA-AKI, followed by CSA-RD and HPP pursuits amid trends like AI-driven trial efficiency and enzyme replacement advances.[5][6] Investor options (e.g., Pfizer) could accelerate scaling, while broader AKI/sepsis pipelines position it for multi-indication dominance. Its evolution from bovine prototypes to human therapies underscores a biotech poised to transform renal critical care, delivering on the promise to save lives in severe conditions.[1][2][7]