ICC Arbitral Tribunal Issues Quantum Award for AOP Health in BESREMi® Proceedings

Dr. Rudolf Widmann, Founder of AOP Health, Photo credit: AOP Health/Studio Koekart Business Wire

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The decision follows the partial final award received in February 2025, in which the ICC Arbitral Tribunal found, among other things, that PharmaEssentia had intentionally breached its contractual obligations and was liable for several claims arising out of the parties’ licensing agreement. The quantum award now determines the amounts due in relation to these claims.

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Tribunal confirms PharmaEssentia’s excessive pricing of up to 900%

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Applying the Tribunal’s reasoning in the quantum award to the product deliveries for the years 2023-2025, PharmaEssentia has overcharged AOP Health by another ca. EUR 65 Mio. After set-off with profit sharing amounts for these years, PharmaEssentia will still owe a substantial amount to AOP Health. In short, AOP Health owes no payment to PharmaEssentia. Meanwhile, PharmaEssentia’s liability towards AOP Health is currently in the three-digit EUR million range.

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Safeguarding Patient Access

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AOP Health welcomes the decision, which the company sees as a further confirmation of its position and its conduct in the proceedings. The company remains focused on ensuring stable and sustainable access to BESREMi® for patients in need. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory.

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Dr. Rudolf Widmann, one of the two founders of AOP Health, says: “After eight years of legal dispute, we welcome the tribunal’s decision because it reduces uncertainty. This award gives us a stronger basis to continue our mission: developing and making available medicines that address high unmet medical needs.”

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As with the previous award, PharmaEssentia may seek a limited review of the quantum award before the competent German courts. Proceedings concerning the review of the February 2025 merit award which was confirmed by the Higher Regional Court of Frankfurt in April 2026 are still pending before the German Federal Court of Justice.

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Background to the dispute

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The conflict concerns BESREMi®, a treatment for rare blood cancers, particularly polycythemia vera. AOP Health acquired the rights for the development and commercialization of BESREMi® in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009.

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Since 2017, PharmaEssentia has repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health damages, while dismissing PharmaEssentia’s counterclaims. Subsequent set-aside proceedings confirmed the award in its essentials, while identifying procedural issues relating to the quantification of damages.

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In November 2020, PharmaEssentia initiated a further legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia and for the use of AOP Health’s clinical trial data in connection with PharmaEssentia’s U.S. marketing authorization. In February 2025, the ICC Arbitral Tribunal issued a partial final award in AOP Health’s favor on liability and dismissed PharmaEssentia’s liability claims in its entirety. The newly received quantum award now specifies the amounts due for the claims upheld in the partial final award.

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About BESREMi®

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BESREMi® is the first interferon that was approved for polycythemia vera, a myelo­proliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.

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BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.

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Please visit: European Medicines Agency Summary of Product Characteristics for:

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About AOP Health

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AOP Health Group is a global pharmaceutical enterprise with headquarters in Vienna. Its mission is to address high unmet medical needs through impactful, science-driven therapies and care models. Since 1996, AOP Health has pioneered research where limited therapies exist, to develop solutions for patients with rare diseases and severe conditions in niche therapeutic areas. Guided by the principle “Needs. Science. Trust.” the AOP Health Group demonstrates its strong commitment to patients and healthcare professionals through innovation and long-term partnerships, to improve patient outcomes worldwide.

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Contacts

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