An International Chamber of Commerce (ICC) arbitral tribunal has delivered a partial final award favoring AOP Health in its ongoing dispute with PharmaEssentia Corporation over the licensing agreement for BESREMi (ropeginterferon alfa-2b). The ruling marks another significant development in the years-long legal battle between the two pharmaceutical companies.
Background of the Dispute
The conflict centers on BESREMi, an innovative treatment for rare blood cancers, particularly polycythemia vera. AOP Health acquired the development and commercialization rights for European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. Since its 2019 launch, the drug has reached approximately 9,000 patients in these territories.
Previous Legal Proceedings
The legal dispute began in 2017 when PharmaEssentia attempted multiple times to terminate its agreement with AOP Health. A 2020 ICC tribunal ruling found these termination attempts unjustified and awarded AOP Health approximately €143 million in damages for project delays. While PharmaEssentia's subsequent appeals to German courts upheld the agreement's validity, the German Federal Supreme Court identified procedural issues regarding damage quantification.
Current Arbitration Outcome
In the latest arbitration proceedings, initiated by PharmaEssentia in November 2020, the tribunal has ruled in AOP Health's favor regarding PharmaEssentia's intentional breaches and liability for several claims. The exact amount of damages remains to be determined in future proceedings.
Clinical Significance of BESREMi
BESREMi represents a significant advancement in treating polycythemia vera, a myeloproliferative neoplasm. As the first approved interferon for this condition in the European Union, it offers a monotherapy option for adult patients without symptomatic enlarged spleen. The drug's administration protocol involves subcutaneous injections every 2-4 weeks, designed for patient self-administration via a pre-filled pen.
Corporate Response
Dr. Rudolf Widmann, AOP Health's co-founder, expressed satisfaction with the tribunal's decision while emphasizing the importance of future cooperation: "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."
Market Impact and Future Outlook
Despite the ongoing legal proceedings, AOP Health has confirmed its commitment to maintaining the supply of ropeginterferon alfa-2b to patients in need. The company's recent expansion, including its first U.S. FDA approval for Rapiblyk at the end of 2024, demonstrates its continued growth in the rare disease and intensive care medicine sectors.
