ICC Tribunal Rules in Favor of AOP Health in BESREMi® Arbitration Case
An International Chamber of Commerce (ICC) tribunal has issued a partial final award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in an ongoing legal dispute with PharmaEssentia Corp. (“PharmaEssentia”) concerning a licensing agreement. The case revolves around reciprocal damage claims arising from disagreements between the two companies over the licensing and commercialization of ropeginterferon alfa-2b, a treatment for rare blood cancers, including polycythemia vera.
The Dispute and the Product at the Center
The primary focus of the dispute is the drug BESREMi® (ropeginterferon alfa-2b), a novel treatment developed by AOP Health for polycythemia vera, a rare blood cancer. This interferon therapy, launched in 2019, was created through an extensive clinical trial program and has become the best-investigated interferon for this condition, as highlighted in key clinical guidelines. AOP Health acquired the rights for the development and commercialization of BESREMi® in the European Union, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. Since its approval by the European Medicines Agency (EMA) in 2014, AOP Health has successfully brought BESREMi® to an estimated 9,000 patients across its licensed territories, providing a life-changing treatment to those suffering from polycythemia vera.
First Arbitration and Set-Aside Proceedings
The legal dispute dates back to 2017 when PharmaEssentia sought to terminate its agreement with AOP Health, accusing the company of various breaches related to the commercialization of BESREMi®. In response, AOP Health sought compensation for delays caused by PharmaEssentia in bringing the drug to market. In 2020, an ICC Arbitral Tribunal ruled that PharmaEssentia’s attempts to terminate the agreement were unjustified. AOP Health was awarded approximately EUR 143 million in damages for the delays, while PharmaEssentia’s counterclaims were dismissed.
PharmaEssentia subsequently filed an application in 2021 to set aside the tribunal’s award, but the Frankfurt Higher Regional Court rejected it. An appeal to the German Federal Supreme Court followed, where the court upheld the validity of the agreement and the dismissal of PharmaEssentia’s claims. However, the Federal Supreme Court found procedural errors in how the damages were quantified, which led to a reassessment of the financial compensation awarded to AOP Health.
Second Arbitration and New Legal Actions
In November 2020, PharmaEssentia initiated new legal proceedings against AOP Health, seeking additional damage claims. AOP Health countered by claiming damages for delays in the European approval process of BESREMi® caused by PharmaEssentia, as well as for the misuse of AOP Health’s clinical trial data in PharmaEssentia’s efforts to obtain marketing authorization for the drug in the U.S. The conflict thus expanded to encompass both claims of breach of contract and misuse of intellectual property.
Partial Final Award in Favor of AOP Health
The latest partial final award from the ICC Arbitral Tribunal ruled in favor of AOP Health concerning PharmaEssentia’s intentional breaches of the agreement and its liability for several claims. However, the tribunal has yet to make a decision on the exact quantum of damages for these claims. AOP Health has expressed satisfaction with the decision but emphasizes that their primary goal remains ensuring patient access to BESREMi® and resolving any issues related to the partnership.
Dr. Rudolf Widmann, co-founder of AOP Health, commented on the ruling, saying, “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® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon approved by the European Medicines Agency for the treatment of polycythemia vera, a myeloproliferative neoplasm (MPN). It is indicated for use in adults as a monotherapy for patients with polycythemia vera without symptomatic enlarged spleen. BESREMi® has demonstrated its overall safety and efficacy in multiple clinical studies, making it the first interferon therapy approved for this indication.
The drug is administered subcutaneously via a pre-filled pen, with an initial dosing schedule of every two weeks or up to every four weeks after stabilization of blood values. This treatment offers patients a highly effective option for managing polycythemia vera, with a significant impact on their health and quality of life.
In conclusion, AOP Health continues to navigate its ongoing legal proceedings with PharmaEssentia, ensuring that BESREMi® remains available to patients in need of this critical treatment. Despite the legal challenges, the company is committed to advancing patient care and resolving disputes to focus on its shared objectives for improving the lives of those affected by polycythemia vera and other rare blood cancers.
