ICC Arbitral Tribunal Issues Quantum Award for AOP Health in BESREMi® Proceedings

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Postmedia has not reviewed the content. by Business Wire ICC Arbitral Tribunal Issues Quantum Award for AOP Health in BESREMi® ProceedingsAuthor of the article: You can save this article by registering for free here. Or sign-in if you have an account.Dr. Rudolf Widmann, Founder of AOP Health, Photo credit: AOP Health/Studio Koekart Business WireVIENNA — An ICC Arbitral Tribunal has awarded AOP Orphan Pharmaceuticals GmbH (“AOP Health”) a total of about EUR 112 Mio in a quantum award issued in the ongoing arbitration proceedings with PharmaEssentia Corp. (“PharmaEssentia”) concerning BESREMi® (ropeginterferon alfa-2b). The award quantifies AOP Health’s damage claims for PharmaEssentia’s intentional breaches at ca. EUR 82 Mio. It also awards AOP Health ca. EUR 31 Mio plus interest as reimbursement for AOP Health overpayments made to PharmaEssentia as a result of excessive pricing in the years 2019-2022. The Tribunal thereby confirmed that PharmaEssentia has been overcharging AOP Health by up to 900% over these years. The Tribunal affirmed AOP Health’s valid set-off of the profit-sharing payments amount owed to PharmaEssentia of approximately EUR 17 Mio against AOP Health’s substantially exceeding damages claims. This means that AOP Health shall not make any payment to PharmaEssentia. Interest on AOP Health’s claims will continue to accrue until PharmaEssentia has made payment. All of PharmaEssentia’s remaining claims of the quantum stage of the proceedings were dismissed. AOP Health was awarded a total of about EUR 112 Mio.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountThe decision follows the partial final award received in February 2025, in which the ICC Arbitral Tribunal found, among other things, that PharmaEssentia had intentionally breached its contractual obligations and was liable for several claims arising out of the parties’ licensing agreement. The quantum award now determines the amounts due in relation to these claims.Tribunal confirms PharmaEssentia’s excessive pricing of up to 900%Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againApplying the Tribunal’s reasoning in the quantum award to the product deliveries for the years 2023-2025, PharmaEssentia has overcharged AOP Health by another ca. EUR 65 Mio. After set-off with profit sharing amounts for these years, PharmaEssentia will still owe a substantial amount to AOP Health. In short, AOP Health owes no payment to PharmaEssentia. Meanwhile, PharmaEssentia’s liability towards AOP Health is currently in the three-digit EUR million range.Safeguarding Patient AccessAOP Health welcomes the decision, which the company sees as a further confirmation of its position and its conduct in the proceedings. The company remains focused on ensuring stable and sustainable access to BESREMi® for patients in need. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory.Dr. Rudolf Widmann, one of the two founders of AOP Health, says: “After eight years of legal dispute, we welcome the tribunal’s decision because it reduces uncertainty. This award gives us a stronger basis to continue our mission: developing and making available medicines that address high unmet medical needs.”As with the previous award, PharmaEssentia may seek a limited review of the quantum award before the competent German courts. Proceedings concerning the review of the February 2025 merit award which was confirmed by the Higher Regional Court of Frankfurt in April 2026 are still pending before the German Federal Court of Justice.Background to the disputeThe conflict concerns BESREMi®, a treatment for rare blood cancers, particularly polycythemia vera. AOP Health acquired the rights for the development and commercialization of BESREMi® in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009.Since 2017, PharmaEssentia has repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health damages, while dismissing PharmaEssentia’s counterclaims. Subsequent set-aside proceedings confirmed the award in its essentials, while identifying procedural issues relating to the quantification of damages.In November 2020, PharmaEssentia initiated a further legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia and for the use of AOP Health’s clinical trial data in connection with PharmaEssentia’s U.S. marketing authorization. In February 2025, the ICC Arbitral Tribunal issued a partial final award in AOP Health’s favor on liability and dismissed PharmaEssentia’s liability claims in its entirety. The newly received quantum award now specifies the amounts due for the claims upheld in the partial final award.BESREMi® is the first interferon that was approved for polycythemia vera, a myelo­proliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.Please visit: European Medicines Agency Summary of Product Characteristics for: AOP Health Group is a global pharmaceutical enterprise with headquarters in Vienna. Its mission is to address high unmet medical needs through impactful, science-driven therapies and care models. Since 1996, AOP Health has pioneered research where limited therapies exist, to develop solutions for patients with rare diseases and severe conditions in niche therapeutic areas. Guided by the principle “Needs. Science. Trust.” the AOP Health Group demonstrates its strong commitment to patients and healthcare professionals through innovation and long-term partnerships, to improve patient outcomes worldwide.View source version on businesswire.com: Isolde Fally Corporate Communications Manager Isolde.Fally@aop-health.com +43 676 500 4048This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.