國際生醫新聞

AOP Health 要求賠償因 PharmaEssentia 導致 BESREMi® 歐洲批准延遲，以及 濫用(misuse) AOP Health 的臨床試驗數據來獲得 PharmaEssentia 的美國核准上市所造成的損失。部分最終裁決支持 AOP Health 的主張，裁定藥華藥( PEC) 承擔多項索賠的故意違約和責任，但仲裁庭尚未就這些索賠的數額作出裁決。(延伸閱讀: 藥華藥(6446)新聞稿: 與 AOP 仲裁案獲部分仲裁判斷(請詳細閱讀)(2/17日股價771元))

2025年2月17日，國際商會 (ICC) 主持的仲裁庭就藥華藥( PharmaEssentia Corp.)與 AOP Orphan Pharmaceuticals GmbH（「AOP Health」）之間的糾紛作出了部分最終裁決，裁定 AOP Health 勝訴。該案的核心是雙方因許可協議糾紛而相互索賠損害賠償。

爭議產品
衝突的焦點是 Ropeginterferon alfa-2b，這是 2019 年推出的一種物質，AOP Health 透過全面的臨床試驗計劃將其開發為一種針對罕見血癌（特別是真性紅血球增多症）的創新治療方法 (BESREMi®)。這使得 BESREMi® 成為主要相關指引1中記錄的此適應症臨床試驗中研究最充分的干擾素。 2009 年，AOP Health 從 PharmaEssentia 手中獲得了 BESREMi® 在歐洲、獨立國家聯合體 (CIS) 和中東市場的開發和商業化權利。

第一次仲裁和撤銷程序
自 2017 年以來，PharmaEssentia 多次試圖終止與 AOP Health 關於 BESREMi® 的協議。 2020 年 10 月，國際商會仲裁庭裁定這些嘗試毫無道理。 因PharmaEssentia 造成的延誤，AOP Health 獲得賠償1.43億歐元約50億台幣，而後者(藥華藥)的反訴被駁回。

PharmaEssentia 於 2021 年提出的撤銷申請被法蘭克福高等地區法院駁回。隨後，該公司向德國聯邦最高法院提出上訴，最終判決維持協議有效性，並駁回PharmaEssentia公司的反訴。德國聯邦最高法院發現，在量化賠償損失方面的1.43億歐元存在程序缺陷。

第二次仲裁
2020 年 11 月，藥華藥(PharmaEssentia )對 AOP Health 提起法律訴訟，聲稱要求賠償損失。 AOP Health 則要求賠償因 PharmaEssentia 導致 BESREMi® 歐洲批准延遲，以及濫用 AOP Health 的臨床試驗數據來獲得 PharmaEssentia 的美國核准上市所造成的損失。

結果：部分最終裁決支持 AOP Health
雖然部分最終裁決支持 AOP Health 的主張，裁定藥華藥( PEC) 承擔多項索賠的故意違約和責任，但仲裁庭尚未就這些索賠的數額作出裁決。

AOP Health 對此決定表示歡迎。它將繼續向需要 Ropeginterferon alfa-2b（BESREMi®）的病人供應該藥物。

關於 BESREMi ®

BESREMi® 是首個獲準用於治療真性紅血球增多症（一種骨髓增生性腫瘤 (MPN)）的干擾素，歐盟批准其作為單一療法用於治療成人無症狀脾腫大的真性紅血球增多症。多項臨床研究證明了其整體安全性和有效性。BESREMi®（ropeginterferon alfa-2b）是一種長效、單聚乙二醇化脯胺酸幹擾素（ATC L03AB15）。最初每兩週注射一次，血液值穩定後最多每四周注射一次。 BESREMi® 設計為透過預充注射筆進行皮下自行注射。

詳細請參閱AOP新聞稿

ICC Arbitral Tribunal rules in favor of AOP Health in arbitration proceedings pertaining to BESREMi® (Ropeginterferon alfa-2b)
(Vienna, 17.02.2025) Today, a tribunal under the auspices of the International Chamber of Commerce (ICC) served a partial final award in a dispute between PharmaEssentia Corp. ("PharmaEssentia") and AOP Orphan Pharmaceuticals GmbH ("AOP Health") in AOP Health's favor. At the heart of the case were reciprocal claims for damages arising from a dispute regarding a licensing agreement between the parties.

The product in dispute
The conflict centers around ropeginterferon alfa-2b, a substance launched in 2019 and that AOP Health has developed into an innovative treatment (BESREMi®) for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines1. AOP Health had acquired the rights for both BESREMi®'s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its sixth year after its approval by European Medicines Agency ("EMA"), AOP Health has successfully made BESREMi® available to an estimated 9,000 patients in AOP Health's licensed territory.

First arbitration and set-aside proceedings
Since 2017, PharmaEssentia repeatedly sought to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal ruled these attempts unjustified. AOP Health was awarded approx. EUR 143 million in damages for project delays caused by PharmaEssentia, while the latter´s counterclaims were dismissed.

PharmaEssentia's 2021 application to set aside the award was rejected by the Frankfurt Higher Regional Court. Upon its subsequent appeal to the German Federal Supreme Court, the agreement's validity and the dismissal of PharmaEssentia 's counterclaims was upheld. The German Federal Supreme Court found procedural flaws with respect to damage quantification of the awarded approx. EUR 143 million, impacting the damages awarded.

Second arbitration
In November 2020, PharmaEssentia initiated a 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 the misuse of AOP Health's clinical trial data for PharmaEssentia's US marketing authorization.

Result: partial final award in favor of AOP Health
While the partial final award rules in favor of AOP Health regarding PEC's intentional breaches and liability for several claims, the tribunal's decision on the quantum of those claims is yet to be made.
AOP Health welcomes this decision. It will continue to supply patients in need of ropeginterferon alfa-2b (BESREMi®).