VIENNA–(BUSINESS WIRE)–Since 2017, PharmaEssentia had repeatedly attempted to terminate the agreement with AOP regarding BESREMi® (Ropeginterferon alfa-2b). In October 2020, after two and a half years of arbitration proceedings, the ICC Arbitral Tribunal rendered its award in the matter. The award states that PharmaEssentia’s multiple attempts to terminate the agreement were unjustified and that AOP is entitled to damages of over €143 million for project delays caused by PharmaEssentia. The award also dismissed all of PharmaEssentia’s counterclaims against AOP.
In December 2020, PharmaEssentia filed a petition with the Frankfurt Higher Regional Court to set aside this award, arguing that the award violated public order and PharmaEssentia’s right to be heard. In March 2021, the Higher Regional Court in Frankfurt rejected this claim and declared the award enforceable.
In March 2021, PharmaEssentia appealed this court decision to the German Federal Court of Justice, again requesting the annulment of the award. On February 14, 2022, the German Federal Court of Justice ruled that the Frankfurt Higher Regional Court had correctly upheld the award with respect to the validity of the agreements and the dismissal of PEC’s counterclaims.
However, it found procedural flaws regarding the supply of products and the quantification of damages. The decision does not affect the merits of AOP’s claims against PEC and will only result in lengthy additional litigation.
“We are pleased that the German Supreme Court has confirmed the validity of our development and commercialization license. We are of course disappointed that the Court found flaws in the reasoning regarding damages. But we have no doubt that in the end we will also recover these confirmed damages in a later proceeding. We will take all necessary steps in due course to ensure that this is ultimately confirmed by a binding arbitration award. That said, we will continue to provide BESREMI® to patients in Europe, the Middle East and territories where AOP holds development and commercialization license rights” Explain Dr. Rudolf WidmannFounder and Board Member, AOP Health Group.
BESREMI® is a long-acting mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerance. BESREMI® is designed to be easily self-administered subcutaneously with a pen once every two weeks or once monthly after stabilization of haematological parameters. This treatment program is expected to lead to overall better safety, tolerability and compliance compared to conventional pegylated interferons. Ropeginterferon alfa-2b was discovered by long-time AOP partner PharmaEssentia. In 2009, AOP in-licensed the exclusive rights for the clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs for the European, Commonwealth of Independent States (CIS) and Middle Eastern markets. . AOP has to date obtained regulatory approval for BESREMI® in the EU, UK, Switzerland and Israel.
For the EMA Summary of Product Characteristics, please visit: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf
About AOP Santé
AOP Orphan Pharmaceuticals GmbH is a member of the AOP Health Group. The AOP Health brand brings together several companies: The international Healthcare group is the European pioneer in integrated therapies for rare diseases and in intensive care. Over the past 25 years, the company has grown into an established provider of integrated therapy solutions from its headquarters in Vienna, subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners in the whole world. This development has been made possible by a continuously high level of investment in research and development on the one hand and a very consistent and pragmatic orientation towards the needs of all our stakeholders on the other – in particular patients and their families as well as the doctors and health professionals who care for them.