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-Wednesday 16 February 2022 [ AETOS Wire ]
(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.
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.
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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Nina Roth, MAS
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