Frankfurt Regional Court upholds BESREMi® arbitral award in favor of AOP Health

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Frankfurt Regional Court upholds BESREMi® arbitral award in favor of AOP Health

Photo of Dr. Rudolf Widmann, Founder of AOP Health Credit: AOP Health/Daniel Ospelt Business Wire

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Vienna – Today, the Supreme Regional Court of Frankfurt approved February 2025¹ the final portion of the ICC award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The decision affirms the award that found the Taiwanese company liable for certain damages. The decision affirms the award that found that PharmaEssentia Corp. is liable for certain damages.

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Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the decision of the Higher Regional Court of Frankfurt which confirms our position. In the interest of our patients, we are dedicated to maintaining a stable and sustainable access to BESREMi® and navigating with responsibility the challenges of the future.“

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Controversial Product

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Controversy surrounds BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health as a treatment for rare blood cancers, especially polycythemia vera, with a comprehensive clinical trial program. This makes BESREMi® the most well-investigated interferon in clinical trials in this indication as documented in the relevant major guidelines.². AOP Health had acquired the rights to both the development and commercialization of BESREMi® in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its seventh year after its approval by the European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to approximately 12,600 AOPterri'story patients.

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Initial Arbitration and Set-Aside Procedures

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Since 2017, PharmaEssentia has repeatedly tried to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, the ICC Arbitral Tribunal rejected these efforts and awarded AOP Health approx. EUR 143 million in damages and dismissed PharmaEssentia's counterclaims in their entirety.

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Subsequent set-aside proceedings confirmed the arbitral award in its essentials, but found procedural errors in relation to the calculation of damages, affecting the amount awarded.

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Second Arbitration

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In November 2020, PharmaEssentia took legal action against AOP Health, alleging damage claims. AOP Health in turn sought damages for delays in European BESREMi® approval caused by PharmaEssentia, and AOP Health's misuse of clinical trial data for US PharmaEssentia marketing approval. The result was the final ICC award in favor of AOP Health, obtained on 17 February 2025, which found PEC guilty of willful infringement and liable for multiple claims. A court decision on the amount of those requests is yet to be made.

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Decision of the Higher Regional Court of Frankfurt Confirms the Position of AOP Health

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In May 2025, PharmaEssentia filed a petition at the Frankfurt Regional Supreme Court to annul the final part of the ICC's final award of 10 February 2025, arguing among other things that the award violated public order and PharmaEssentia's right to be heard.

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On April 24, 2026, the Frankfurt District Court dismissed the entire claim and declared the award binding. An appeal to the German Court of Justice is possible.

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AOP Health believes this decision vindicates its position and reinforces its commitment to patients. The company will continue to supply patients who need ropeginterferon alfa-2b (BESREMi®), and maintain the high levels of quality patients depend on.

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About BESREMi®

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

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

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For the EMA Summary of Product Characteristics please visit:

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About AOP Health

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AOP Health is a global healthcare group with roots in Austria, where AOP Orphan Pharmaceuticals GmbH (“AOP Health”) is headquartered. Since 1996, AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the areas of rare diseases and critical care medicine.

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At the end of 2024, AOP Health received its first US FDA approval for Rapiblek^TMa medicine intended for patients in the intensive care unit, thereby strengthening its commitment to making treatments available to patients around the world. AOP Health Group has established itself globally as a pioneer in integrated medical solutions and operates worldwide through subsidiaries, affiliates, and a strong network of partners.

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With a claim “Need. Science. Trust.” AOP Health Group emphasizes its commitment to research and development, and the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of AOP Health Group's activities.

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https://www.aop-health.com/global_en/press/press-releases/icc-arbitral-tribunal-ruling-aop-health/

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ELN Guideline (2022), NCCN Guideline (2024), Onkopedia Leitlinie (2023)

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