AOP-ORPHAN-PHARMA
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220215005749/en/
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220215005749/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Kaneka Obtains Halal Certificate for KANEKA UBIQUINOL TM9.7.2025 03:30:00 CEST | Press release
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has obtained “Halal Certificate (Certification Number: 355-TSRI/24)” for its functional food ingredient, KANEKA UBIQUINOLTM (active form of coenzyme Q10) powder, under the assessment of Shariah Research Institute of Takushoku University, and issued by JAPAN MUSLIM ASSOCIATION, a religious corporation, on May 28. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708279133/en/ Halal certificate Halal certification is a system in which relevant organizations verify that products or services do not contain ingredients prohibited under Shariah (Islamic law) and certify their compliance with Shariah. We actively pursue the acquisition of various certifications to ensure the safety and security of our raw materials, and we are pleased to announce that we have obtained a Halal Certificate for KANEKA UBIQUINOLTM. Currently, the Muslim populati
SiPearl: Final closing of €130m Series A with Cathay Venture (Taiwan), EIC Fund and France 20308.7.2025 17:25:00 CEST | Press release
Tape-out of Rhea1, the most complex processor ever designed in Europe which will equip JUPITER, the 1st European exascale supercomputer Largest Series A in the European fabless semiconductor industry including €32m in new funding to close Series A and prepare the launch of Series B Strengthening ties with Taiwan’s semiconductor ecosystem to complement Europe’s sovereignty in supercomputing and AI SiPearl, the company building European high-performance energy-efficient processors for supercomputing and AI has achieved the definitive closing of its €130m Series A with a third tranche of €32m. Seed funded by the European Union, SiPearl was launched in January 2020 under the auspices of the European Processor Initiative consortium which aims to foster the return of high-performance energy-efficient processor technologies in Europe. Since then, the company has fulfilled its mission by building a world-class processor team of 200 employees in France, Spain, and Italy, set up its own sovereig
LambdaTest Unveils Smart Branching and Baseline Management to Modernize Visual Testing Workflows8.7.2025 17:00:00 CEST | Press release
SmartUI now aligns visual testing with real-world development practices, eliminating baseline confusion and making visual QA effortless across teams LambdaTest, a GenAI-powered quality engineering platform, has announced the release of SmartUI’sSmart Branching and Baseline Management, a major leap forward in visual testing. This update eliminates long-standing bottlenecks caused by outdated baseline strategies and introduces an intelligent, streamlined way for development teams to manage visual testing across complex Git workflows. Modern development teams utilise feature branches, release versions, and hotfix workflows; however, most visual testing tools still rely on comparisons against the main branch, resulting in irrelevant failures and time-consuming approvals. LambdaTest’s SmartUI changes that with features purpose-built for today’s branching strategies. Smart Branch Comparison ensures visual tests are run against the correct baseline, comparing within the same feature branch in
Connectivity as Versatile as the Aircraft, Starlink High-Speed Internet Now Available for Cessna Caravan8.7.2025 16:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced an additional high-speed internet connectivity solution for the Cessna Citation Caravan following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. AeroMech’s STC utilizes Starlink’s constellation of Low Earth Orbit (LEO) satellites to provide more reliable connectivity over land, water and remote areas, where traditional in-flight Wi-Fi may not have service. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708514119/en/ Textron Aviation announced an additional high-speed internet connectivity solution for the Cessna Citation Caravan following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. (Photo: Textron Aviation) “The Cessna Caravan is so versatile,
Rigaku Announces STAvesta, a Thermal Analyzer Tailor-made for Next-generation Material Development8.7.2025 16:00:00 CEST | Press release
Supports a wide range of users from novices to experts, serving a wide variety of needs Rigaku Corporation, a Group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; hereinafter “Rigaku”) has launched worldwide sales of STAvesta, a thermal analyzer that simultaneously measures a sample’s weight and change in calorific value during heating. STAvesta responds to needs in a wide array of fields where thermal analysis is required. It is expected to find use in a wide variety of material-analysis applications for the development of advanced features and complex materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708207135/en/ STAvesta FlatBlank, a Revolutionary Auto-adjustment Feature, Dramatically Reduces Workload In conventional thermal analysis, baseline adjustment must be performed by hand before measurement can begin. This process can be time-consuming and frustrating, particu
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom