Op maandag 14 februari 2022 besliste het Duitse Federale Hof van Justitie over de betwisting van de toekenning door PEC in het geschil tussen AOP Orphan Pharmaceuticals GmbH en PharmaEssentia Corporation. Het besluit bevestigde dat de pogingen van PharmaEssentia om AOP zijn licentierechten voor Ropeginterferon alfa-2b te ontnemen, zijn mislukt. Het handhaaft het vonnis waarbij de licentieovereenkomst geldig wordt verklaard en PharmaEssentia aansprakelijk is voor bepaalde schade en alle vorderingen van PharmaEssentia jegens AOP worden afgewezen. Het constateert echter procedurele fouten met betrekking tot de levering van producten en de kwantificering van de schade, die van invloed zijn op de toegekende schadevergoeding. AOP zal de verkoop van BESREMi® voortzetten en alle schadevergoeding eisen.

WENEN–(BUSINESS WIRE)– Sinds 2017 heeft PharmaEssentia herhaaldelijk geprobeerd de overeenkomst met AOP met betrekking tot BESREMi® (Ropeginterferon alfa-2b) te beëindigen. In oktober 2020 heeft het ICC Arbitragetribunaal, na tweeënhalf jaar arbitrageprocedures, uitspraak gedaan in de zaak. De prijs stelt vast dat de meerdere pogingen van PharmaEssentia om de overeenkomst te beëindigen onterecht waren, en dat AOP recht heeft op een schadevergoeding van meer dan 143 miljoen euro voor projectvertragingen veroorzaakt door PharmaEssentia. De uitspraak wees ook alle tegenvorderingen van PharmaEssentia tegen AOP af.

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German Federal Court of Justice Upholds AOP’s License Rights in Ropeginterferon and PEC’s Liability for Damages

On Monday February 14, 2022 the German Federal Court of Justice decided on PEC’s challenge of the award in the dispute between AOP Orphan Pharmaceuticals GmbH and PharmaEssentia Corporation. The decision confirmed that PharmaEssentia’s attempts to deprive AOP of its license rights in Ropeginterferon alpha-2b have failed. It upholds the award finding the License Agreement valid and PharmaEssentia liable for certain damages and dismissing all PharmaEssentia’s claims against AOP. However, it finds procedural flaws with respect to product supply and damage quantification, impacting the damages awarded. AOP will continue BESREMi^® sales and claim all damages.

VIENNA–(BUSINESS WIRE)– Since 2017, PharmaEssentia had repeatedly attempted to terminate the agreement with AOP concerning BESREMi^® (Ropeginterferon alfa-2b). In October 2020, after two and a half years of arbitral proceedings, the ICC Arbitral Tribunal issued 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 EUR 143 million for project delays caused by PharmaEssentia. The award also dismissed all of PharmaEssentia’s counterclaims against AOP.

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Dr. Rudolf Widmann Founder and Board Member, AOP Health Group. Copyright Photographs: @studio koekart

In December 2020, PharmaEssentia filed an application 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 Frankfurt Higher Regional Court dismissed this application and declared the award enforceable.

In March 2021, PharmaEssentia filed an appeal against this court decision with the German Federal Court of Justice, requesting again that the award be set aside. On February 14, 2022, the German Federal Court of Justice decided that the Frankfurt Higher Regional Court correctly upheld the award with respect to the validity of the agreements and the dismissal of PEC’s counterclaims.

However, it found procedural flaws with respect to product supply and damage quantification. The decision has no implication regarding the merits of AOP’s claims against PEC and will only result in protracted further proceedings.

“We are satisfied that the German Supreme Court 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 we will ultimately also recover these confirmed damages in further proceedings. We will take all necessary steps in due course to have this ultimately confirmed by an enforceable arbitral award. Having said that, we will continue supplying BESREMi^® to patients in Europe, the Middle East and territories where AOP is the holder of the developing and commercialization license rights” explains Dr. Rudolf Widmann, Founder and Board Member, AOP Health Group.

About BESREMi^®

BESREMi^® is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi^® is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons. Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP. In 2009, AOP in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs for 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 Health

AOP Orphan Pharmaceuticals GmbH is a member of the AOP Health Group. The brand AOP Health incorporates several companies: The international Healthcare Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the company has become an established provider of integrated therapy solutions from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all our stakeholders on the other – especially the patients and their families as well as also the doctors and care professionals treating them.

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Contacts

For more information, please contact:

Nina Roth, MAS
Head of Corporate Communications

+43 676 3131509

nina.roth@aoporphan.com