ICC Arbitral Tribunal Rules in Favor of AOP Health in Arbitration Proceedings Pertaining to BESREMi® (Ropeginterferon alfa-2b)

Today, a tribunal under the auspices of the International Chamber of Commerce (ICC) served a partial final award in a dispute between PharmaEssentia Corp. (“PharmaEssentia”) and AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in AOP Health’s favor. At the heart of the case were reciprocal claims for damages arising from a dispute regarding a licensing agreement between the parties.

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The product in dispute

The conflict centers around ropeginterferon alfa-2b, a substance launched in 2019 and that AOP Health has developed into an innovative treatment (BESREMi®) for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines¹. AOP Health had acquired the rights for both BESREMi®’s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its sixth year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 9,000 patients in AOP Health’s licensed territory.

First arbitration and set-aside proceedings

Since 2017, PharmaEssentia repeatedly sought to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal ruled these attempts unjustified. AOP Health was awarded approx. EUR 143 million in damages for project delays caused by PharmaEssentia, while the latter´s counterclaims were dismissed.

PharmaEssentia’s 2021 application to set aside the award was rejected by the Frankfurt Higher Regional Court. Upon its subsequent appeal to the German Federal Supreme Court, the agreement’s validity and the dismissal of PharmaEssentia 's counterclaims was upheld. The German Federal Supreme Court found procedural flaws with respect to damage quantification of the awarded approx. EUR 143 million, impacting the damages awarded.

Second arbitration

In November 2020, PharmaEssentia initiated a 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 the misuse of AOP Health’s clinical trial data for PharmaEssentia’s US marketing authorization.

Result: partial final award in favor of AOP Health

While the partial final award rules in favor of AOP Health regarding PEC's intentional breaches and liability for several claims, the tribunal’s decision on the quantum of those claims is yet to be made.

AOP Health welcomes this decision. It will continue to supply patients in need of ropeginterferon alfa-2b (BESREMi®).

Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We are pleased that the ICC Arbitral Tribunal decided in our favor again. However, we still believe that an outcome benefiting the patients most can only be reached by finding a joint solution to not only overcome the past but also future challenges in our cooperation. We are willing to focus on the common objectives and not the differences.”

About BESREMi®

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.

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.

For the EMA Summary of Product Characteristics please visit: BESREMi®

About AOP Health

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

At the end of 2024, AOP Health received its first U.S. FDA approval for Rapiblyk^™, a medication aimed at patients in intensive care units, thereby further strengthening its commitment to making therapies available for patients worldwide. The AOP Health Group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners.

With the claim "Needs. Science. Trust." the AOP Health Group emphasizes its commitment to research and development, as well as 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 the AOP Health Group’s actions.

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

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