Frankfurt Court Upholds Arbitral Award Securing BESREMi Access for Polycythemia Vera Patients
核心洞察
The Frankfurt Higher Regional Court upheld an ICC arbitral award in favor of AOP Health (搜索) against PharmaEssentia, confirming the Taiwanese company's liability for damages in their BESREMi dispute.
The ruling ensures continued access to BESREMi (ropeginterferon alfa-2b) for approximately 12,600 polycythemia vera (搜索) patients across AOP Health (搜索)'s European, CIS, and Middle Eastern territories.
BESREMi represents the first interferon approved specifically for polycythemia vera (搜索) treatment and is described as the most extensively studied interferon in clinical trials for this rare blood cancer (搜索) indication.
The Frankfurt Higher Regional Court has upheld a February 2025 ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (AOP Health (搜索)) in its ongoing legal dispute with Taiwan's PharmaEssentia Corp (搜索)., securing continued patient access to the rare blood cancer (搜索) treatment BESREMi. The April 24, 2026 ruling dismissed PharmaEssentia's application to set aside the award and declared it enforceable.
Legal Victory Protects Patient Access
Dr. Rudolf Widmann, one of AOP Health (搜索)'s two founders, emphasized the patient-focused implications of the decision: "We very much welcome the Frankfurt Higher Regional Court's decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi and to responsibly navigating future challenges."
The court's ruling ensures that AOP Health (搜索) can continue supplying BESREMi (ropeginterferon alfa-2b) to an estimated 12,600 patients across its licensed territories, which include European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
Complex Legal History Over Rare Disease Treatment
The dispute centers on BESREMi, launched in 2019 as an innovative treatment for polycythemia vera (搜索), a rare blood cancer (搜索) classified as a myeloproliferative neoplasm (搜索). AOP Health (搜索) acquired development and commercialization rights for these territories from PharmaEssentia in 2009, subsequently developing the drug through a comprehensive clinical trial program.
The legal conflict began in 2017 when PharmaEssentia repeatedly attempted to terminate its agreement with AOP Health (搜索). In October 2020, an ICC Arbitral Tribunal initially rejected these termination attempts and awarded AOP Health approximately EUR 143 million in damages while dismissing PharmaEssentia's counterclaims entirely.
However, subsequent set-aside proceedings confirmed the award's essentials but identified procedural flaws in damage quantification. This led to a second arbitration initiated by PharmaEssentia in November 2020, where AOP Health (搜索) counter-claimed damages for delays in BESREMi's European approval and alleged misuse of clinical trial data for PharmaEssentia's US marketing authorization.
Breakthrough Treatment for Rare Blood Cancer
BESREMi holds the distinction of being the first interferon approved specifically for polycythemia vera (搜索) treatment in the European Union. The drug is indicated as monotherapy in adults for treating polycythemia vera without symptomatic enlarged spleen, with safety and efficacy demonstrated across multiple clinical studies.
According to major clinical guidelines including the ELN Guideline (2022), NCCN Guideline (2024), and Onkopedia Leitlinie (2023), BESREMi represents the most extensively investigated interferon in clinical trials for this indication.
The treatment is administered as a long-acting, mono-pegylated proline interferon, initially given once every two weeks and potentially extended to every four weeks after blood value stabilization. Patients can self-administer the subcutaneous injection using a pre-filled pen device.
Expanding Global Presence
AOP Health (搜索), headquartered in Austria, has been developing innovative solutions for unmet medical needs since 1996, particularly focusing on rare diseases and intensive care medicine. The company recently expanded its US presence, receiving its first FDA approval in late 2024 for Rapiblyk, a medication for intensive care unit patients.
While PharmaEssentia retains the option to appeal to the German Federal Court of Justice, AOP Health (搜索) maintains its commitment to ensuring continued high-quality access to ropeginterferon alfa-2b for patients requiring this specialized treatment. The company operates globally through subsidiaries, representations, and partner networks under the motto "Needs. Science. Trust."