ICC Arbitral Tribunal Decides in Favor of AOP Health in Arbitration over BESREMi® (Ropeginterferon alfa-2b)
A tribunal under the International Chamber of Commerce (ICC) issued a partial final award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its ongoing dispute with PharmaEssentia Corp. (“PharmaEssentia”). The case centers around claims for damages related to a licensing agreement between the two companies.
The Product at the Core of the Dispute
The conflict revolves around ropeginterferon alfa-2b, a drug introduced in 2019 and developed by AOP Health into an innovative treatment for rare blood cancers, particularly polycythemia vera, under the brand name BESREMi®. Through an extensive clinical trial program, BESREMi® has become the most studied interferon for this indication, as noted in key guidelines. In 2009, AOP Health obtained the rights to develop and commercialize BESREMi® in the European, Commonwealth of Independent States (CIS), and Middle Eastern regions from PharmaEssentia. Since receiving approval from the European Medicines Agency (EMA), AOP Health has made BESREMi® available to an estimated 9,000 patients across its licensed markets.
First Arbitration and Set-Aside Proceedings
PharmaEssentia had sought to terminate the licensing agreement with AOP Health since 2017. In October 2020, an ICC Arbitral Tribunal ruled that PharmaEssentia’s attempts were unjustified, and awarded AOP Health approximately EUR 143 million in damages for delays caused by PharmaEssentia. PharmaEssentia’s counterclaims were dismissed.
PharmaEssentia’s request to set aside the award was rejected by the Frankfurt Higher Regional Court, and the German Federal Supreme Court upheld the agreement’s validity and the dismissal of PharmaEssentia’s counterclaims. However, the Federal Court found procedural issues related to the quantification of the EUR 143 million in damages, which may affect the final amount awarded.
Second Arbitration
In November 2020, PharmaEssentia launched another legal action against AOP Health, claiming damages. AOP Health, in turn, sought damages for delays in BESREMi®’s approval in Europe caused by PharmaEssentia, as well as for the alleged misuse of AOP Health’s clinical trial data in PharmaEssentia’s US marketing authorization.
Outcome: Partial Final Award in Favor of AOP Health
The ICC tribunal’s partial final award ruled in favor of AOP Health, affirming PharmaEssentia’s intentional breaches and liability for several claims. However, the tribunal has yet to make a decision on the quantum of these claims.
AOP Health welcomed the decision, reaffirming its commitment to continue supplying BESREMi® to patients in need.
Dr. Rudolf Widmann, one of the co-founders of AOP Health, commented: “We are pleased with the ICC Arbitral Tribunal’s decision in our favor. However, we still believe that the best outcome for patients can only be achieved by finding a joint solution to address both past and future challenges in our collaboration. We are committed to focusing on shared objectives rather than 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.
