ICC Arbitral Tribunal Points Quantum Award for AOP Well being in BESREMi® Proceedings

VIENNA — An ICC Arbitral Tribunal has awarded AOP Orphan Prescribed drugs GmbH (“AOP Well being”) a complete of about EUR 112 Mio in a quantum award issued within the ongoing arbitration proceedings with PharmaEssentia Corp. (“PharmaEssentia”) regarding BESREMi® (ropeginterferon alfa-2b). The award quantifies AOP Well being’s injury claims for PharmaEssentia’s intentional breaches at ca. EUR 82 Mio. It additionally awards AOP Well being ca. EUR 31 Mio plus curiosity as reimbursement for AOP Well being overpayments made to PharmaEssentia because of extreme pricing within the years 2019-2022. The Tribunal thereby confirmed that PharmaEssentia has been overcharging AOP Well being by as much as 900% over these years. The Tribunal affirmed AOP Well being’s legitimate set-off of the profit-sharing funds quantity owed to PharmaEssentia of roughly EUR 17 Mio in opposition to AOP Well being’s considerably exceeding damages claims. Which means that AOP Well being shall not make any cost to PharmaEssentia. Curiosity on AOP Well being’s claims will proceed to accrue till PharmaEssentia has made cost. All of PharmaEssentia’s remaining claims of the quantum stage of the proceedings had been dismissed. AOP Well being was awarded a complete of about EUR 112 Mio.

The choice follows the partial closing award acquired in February 2025, through which the ICC Arbitral Tribunal discovered, amongst different issues, that PharmaEssentia had deliberately breached its contractual obligations and was accountable for a number of claims arising out of the events’ licensing settlement. The quantum award now determines the quantities due in relation to those claims.

Making use of the Tribunal’s reasoning within the quantum award to the product deliveries for the years 2023-2025, PharmaEssentia has overcharged AOP Well being by one other ca. EUR 65 Mio. After set-off with revenue sharing quantities for these years, PharmaEssentia will nonetheless owe a considerable quantity to AOP Well being. In brief, AOP Well being owes no cost to PharmaEssentia. In the meantime, PharmaEssentia’s legal responsibility in direction of AOP Well being is at the moment within the three-digit EUR million vary.

AOP Well being welcomes the choice, which the corporate sees as an extra affirmation of its place and its conduct within the proceedings. The corporate stays targeted on guaranteeing steady and sustainable entry to BESREMi® for sufferers in want. In its seventh yr after its approval by European Medicines Company (“EMA”), AOP Well being has efficiently made BESREMi® accessible to an estimated 12,600 sufferers in AOP Well being’s licensed territory.

Dr. Rudolf Widmann, one of many two founders of AOP Well being, says: “After eight years of authorized dispute, we welcome the tribunal’s determination as a result of it reduces uncertainty. This award offers us a stronger foundation to proceed our mission: growing and making accessible medicines that tackle excessive unmet medical wants.”

As with the earlier award, PharmaEssentia could search a restricted evaluate of the quantum award earlier than the competent German courts. Proceedings in regards to the evaluate of the February 2025 advantage award which was confirmed by the Greater Regional Courtroom of Frankfurt in April 2026 are nonetheless pending earlier than the German Federal Courtroom of Justice.

The battle issues BESREMi®, a remedy for uncommon blood cancers, notably polycythemia vera. AOP Well being acquired the rights for the event and commercialization of BESREMi® within the European, Commonwealth of Unbiased States (CIS), and Center Japanese markets from PharmaEssentia in 2009.

Since 2017, PharmaEssentia has repeatedly tried to terminate its settlement with AOP Well being relating to BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these makes an attempt and awarded AOP Well being damages, whereas dismissing PharmaEssentia’s counterclaims. Subsequent set-aside proceedings confirmed the award in its necessities, whereas figuring out procedural points regarding the quantification of damages.

In November 2020, PharmaEssentia initiated an extra authorized motion in opposition to AOP Well being, alleging injury claims. AOP Well being in flip claimed damages for delays in BESREMi®’s European approval brought on by PharmaEssentia and for using AOP Well being’s medical trial knowledge in reference to PharmaEssentia’s U.S. advertising and marketing authorization. In February 2025, the ICC Arbitral Tribunal issued a partial closing award in AOP Well being’s favor on legal responsibility and dismissed PharmaEssentia’s legal responsibility claims in its entirety. The newly acquired quantum award now specifies the quantities due for the claims upheld within the partial closing award.

https://www.businesswire.com/information/house/20260807889741/en/

Isolde Fally
Company Communications Supervisor
Isolde.Fally@aop-health.com
+43 676 500 4048