Frankfurt Increased Regional Court docket upholds BESREMi® arbitral award in favor of AOP Well being

Portrait Dr. Rudolf Widmann, Founder AOP Health Credit: AOP Health/Daniel Ospelt — Portrait Dr. Rudolf Widmann, Founder AOP Well being Credit score: AOP Well being/Daniel Ospelt Enterprise Wire

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VIENNA — At the moment, the Increased Regional Court docket of Frankfurt upheld the February 2025¹ partial closing ICC arbitral award in favor of AOP Orphan Prescription drugs GmbH (“AOP Well being”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which discovered the Taiwanese firm to be accountable for sure damages. The ruling confirms the award which discovered PharmaEssentia Corp. to be accountable for sure damages.

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Dr. Rudolf Widmann, one of many two founders of AOP Well being, explains: “We very a lot welcome the Frankfurt Increased Regional Court docket’s resolution that confirms our place. Within the curiosity of our sufferers, we’re devoted to sustaining secure and sustainable entry to BESREMi® and to responsibly navigating future challenges.”

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The Product in Dispute

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The battle facilities round BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Well being into an modern therapy for uncommon blood cancers, notably polycythemia vera, by a complete scientific trial program. This makes BESREMi® the very best investigated interferon in scientific trials on this indication as documented within the main related tips². AOP Well being had acquired the rights for each BESREMi®’s growth and commercialization within the European, Commonwealth of Impartial States (CIS), and Center Japanese markets from PharmaEssentia in 2009. In its seventh yr after its approval by European Medicines Company (“EMA”), AOP Well being has efficiently made BESREMi® obtainable to an estimated 12,600 sufferers in AOP Well being’s licensed territory.

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First Arbitration and Set-aside Proceedings

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Since 2017, PharmaEssentia repeatedly tried to terminate its settlement with AOP Well being relating to BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these makes an attempt and awarded AOP Well being approx. EUR 143 million in damages and dismissed PharmaEssentia’s counterclaims in its entirety.

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Subsequent set-aside proceedings confirmed the arbitral award in its necessities, however discovered procedural flaws with respect to break quantification, impacting the damages awarded.

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Second Arbitration

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In November 2020, PharmaEssentia initiated a authorized motion in opposition to AOP Well being, alleging injury claims. AOP Well being in flip claimed damages for delays in BESREMi®’s European approval brought on by PharmaEssentia, and the misuse of AOP Well being’s scientific trial information for PharmaEssentia’s US advertising authorization. The end result was a partial closing ICC arbitral award in favor of AOP Well being, acquired on 17 February 2025, which discovered PEC responsible of intentional breaches and accountable for a number of claims. The tribunal’s resolution on the quantum of these claims is but to be made.

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Ruling of Increased Regional Court docket of Frankfurt Confirms AOP Well being’s Place

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In Might 2025, PharmaEssentia filed an software with the Frankfurt Increased Regional Court docket to put aside the partial closing ICC arbitral award dated 10 February 2025, arguing amongst different issues that the award violated public order and PharmaEssentia’s proper to be heard.

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On 24 April 2026, the Frankfurt Increased Regional Court docket dismissed this software in its entirety and declared the award enforceable. An attraction to the German Federal Court docket of Justice is feasible.

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AOP Well being believes this resolution confirms its place and reinforces its dedication to sufferers. The corporate will proceed to provide sufferers in want of ropeginterferon alfa-2b (BESREMi®), sustaining the excessive requirements of high quality sufferers rely on.

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About BESREMi®

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BESREMi® is the primary interferon that was authorized for polycythemia vera, a myeloproliferative neoplasm (MPN), indicated within the European Union as monotherapy in adults for therapy of polycythemia vera with out symptomatic enlarged spleen. Its general security and efficacy have been demonstrated in a number of scientific research.

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

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For the EMA Abstract of Product Traits please go to:

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About AOP Well being

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AOP Well being is a world healthcare group with roots in Austria, the place the headquarters of AOP Orphan Prescription drugs GmbH (“AOP Well being”) is situated. Since 1996, the AOP Well being Group has been devoted to creating modern options to deal with unmet medical wants, notably within the fields of uncommon ailments and intensive care medication.

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On the finish of 2024, AOP Well being acquired its first U.S. FDA approval for Rapiblyk^TM, a drugs geared toward sufferers in intensive care items, thereby additional strengthening its dedication to creating therapies obtainable for sufferers worldwide. The AOP Well being Group has established itself internationally as a pioneer in built-in remedy options and operates worldwide by subsidiaries, representations, and a robust community of companions.

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With the declare “Wants. Science. Belief.” the AOP Well being Group emphasizes its dedication to analysis and growth, in addition to the significance of constructing relationships with physicians and affected person advocacy teams to make sure that the wants of those stakeholders are mirrored in all features of the AOP Well being Group’s actions.

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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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