維也納--(BUSINESS WIRE)--八月 8, 2026--
(美國商業資訊)-- 國際商會(ICC)仲裁庭就AOP Orphan Pharmaceuticals GmbH (“AOP Health”)與PharmaEssentia Corp. (“PharmaEssentia”)之間關於BESREMi® (ropeginterferon alfa-2b)的持續仲裁程序做出一項金額裁定，裁定AOP Health獲得總計約1.12億歐元賠償。該裁定將AOP Health因PharmaEssentia故意違約而提出的損害賠償請求金額確定為約8200萬歐元。同時，仲裁庭還裁定AOP Health獲得約3100萬歐元及利息，做為AOP Health在2019年至2022年期間因PharmaEssentia定價過高而多付之款項的補償。仲裁庭由此確認，PharmaEssentia在上述年份中向AOP Health收取的費用存在高達900%的超額加價。仲裁庭還確認，AOP Health有權將其欠付PharmaEssentia的約1700萬歐元利潤分成款項，與其遠超該金額的AOP Health損害賠償請求進行有效抵銷。這表示AOP Health無需向PharmaEssentia支付任何款項。AOP Health的債權利息將持續計息，直至PharmaEssentia完成付款。PharmaEssentia在金額裁定階段提出的所有其餘請求均被駁回。
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該裁定是在繼2025年2月收到的部分終局裁定之後做出。在該裁定中，ICC仲裁庭認定PharmaEssentia故意違反合約義務，並需對雙方授權合約產生的多項索賠負擔責任。本次金額裁定則確定了與這些索賠相關的應付金額。
仲裁庭確認PharmaEssentia超額加價幅度高達900%
將仲裁庭在金額裁定中的論證應用於2023至2025年的產品交付，PharmaEssentia還向AOP Health多收取了約6500萬歐元的費用。在與這些年份的利潤分成金額抵銷後，PharmaEssentia仍需向AOP Health支付一大筆款項。簡而言之，AOP Health不欠PharmaEssentia任何款項，而PharmaEssentia目前對AOP Health的負債金額高達數億歐元。
保障病患用藥可及性
AOP Health對該裁定表示歡迎，公司認為這進一步印證了其在仲裁程序中的立場和行為的正當性。公司將繼續致力於確保有需要的病患能夠穩定、持續地獲得BESREMi®。在歐洲藥品管理局(EMA)核准該藥物後的第七年，AOP Health已成功使BESREMi®嘉惠AOP Health授權區域內的約12,600名病患。
AOP Health的兩位創辦人之一的Rudolf Widmann博士表示：「經過八年的法律糾紛，我們歡迎仲裁庭的裁定，因為它減少了不確定性。這一裁定為我們繼續履行自身使命提供了更堅實的基礎：開發和提供滿足大量尚未被滿足之醫療需求的藥物。」
與此前的裁定一樣，PharmaEssentia可向有管轄權的德國法院申請對金額裁定進行有限覆審。針對2025年2月實質性裁定的覆審程序仍在德國聯邦最高法院審理中，該裁定已於2026年4月獲得法蘭克福高等地區法院的確認。
爭議背景
相關糾紛涉及BESREMi®，一種用於治療罕見血液癌症（尤其是真性多紅血球症）的藥物。2009年，AOP Health從PharmaEssentia獲得了BESREMi®在歐洲、獨立國協(CIS)及中東市場的開發和商業化權利。
自2017年以來，PharmaEssentia多次試圖終止其與AOP Health之間關於BESREMi®的協議。2020年10月，ICC仲裁庭駁回了這些請求，裁定AOP Health獲得損害賠償，同時駁回了PharmaEssentia的反訴。隨後的撤銷程序確認了該裁定的基本內容，同時指出了與損害賠償金額相關的程序問題。
2020年11月，PharmaEssentia對AOP Health提起進一步法律訴訟，提出損害賠償請求。AOP Health則反訴要求賠償，理由是PharmaEssentia導致BESREMi®歐洲核准延遲，以及PharmaEssentia在其美國上市授權中使用了AOP Health的臨床試驗資料。2025年2月，ICC仲裁庭就責任問題做出有利於AOP Health的部分終局裁定，並全面駁回了PharmaEssentia的責任索賠。如今，新收到的金額裁定則明確了部分終局裁定中獲支持的索賠所對應的應付金額。
關於 BESREMi®
BESREMi®是首款獲得歐盟批准用於治療真性紅血球增多症，即一種骨髓增殖性肿瘤（MPN）的干擾素，適用於單一療法治療成人真性紅血球增多症，且無症狀性脾臟腫大。其整體安全性和療效已在多項臨床研究中證實。
BESREMi®（羅培干擾素α-2b）是一種長效型單聚乙二醇化脯氨酸干擾素（ATC L03AB15）。最初為每兩週施用一次，或在血液學參數穩定後最多每四周給藥一次。BESREMi®設計為使用注射筆自我皮下給藥。
請造訪：歐洲藥品管理局產品特性摘要：BESREMi®
關於AOP Health
AOP Health Group是一家總部位於維也納的全球性製藥企業。其使命是透過具有影響力的、以科學為驅動的療法和醫療模式來滿足大量尚未被滿足的醫療需求。自1996年以來，AOP Health一直在治療手段有限的領域進行開創性研究，為罕見疾病和特定治療領域的重症病患開發解決方案。秉持「需求、科學、信任」的原則，AOP Health Group透過創新和長期合作夥伴關係，展現了對病患和醫療專業人士的堅定承諾，致力於改善全球病患的治療結果。
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CONTACT: Isolde Fally
企業傳播經理
Isolde.Fally@aop-health.com
+43 676 500 4048
KEYWORD: AUSTRIA EUROPE
INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL ONCOLOGY GENERAL HEALTH HEALTH CLINICAL TRIALS
SOURCE: AOP Health
Copyright Business Wire 2026.
PUB: 08/08/2026 08:00 AM/DISC: 08/08/2026 08:01 AM
http://www.businesswire.com/news/home/20260807033003/zh
AOP Health創辦人Rudolf Widmann博士，照片來源：AOP Health/Studio Koekart
FLORENCE, S.C. (AP) — Few people have anything bad to say about Darline Graham, who was catapulted from obscurity last month when she was appointed to replace her late brother Lindsey Graham in the U.S. Senate.
“I think Darline’s wonderful,” said Kathy Bustos of Mount Pleasant, after attending a Republican forum last week.
But that doesn't mean Bustos wants to vote for her in the state's special primary on Tuesday.
“I think it’s a very nice gesture for her to have the rest of his term to complete, but I’m not sure that she’s really qualified or ready to be elected to the Senate,” she said.
It's a common sentiment among Republican voters pondering an unexpected decision about replacing Lindsey Graham, who was nominated for a fifth term before he died from a tear in his aorta. Darline Graham was often by his side throughout his career, but she remains largely unknown in South Carolina's clubby political circles.
President Donald Trump has endorsed her, and she's backed by the National Republican Senatorial Committee, which is running television advertising to support her candidacy.
However, Graham has been largely absent from the campaign trail, spending most of her time in Washington as an interim senator. Her appointment to the role, instead of giving her a leg up over the competition, may ultimately hold her back by preventing her from getting to know voters during a weeks-long sprint to Tuesday.
She is up against several well-known Republicans, including Representatives Russell Fry and Ralph Norman, as well as former Gov. Mark Sanford. The crowded field makes a runoff more likely, and it would be held on Aug. 25.
All of them spoke at a Friday meeting of the Fourth District Republican Club in Greenville, but Graham sent a video message, saying she was “in Washington working hard for you." She promised to be "a great friend and ally” to Trump and that she wanted to “earn your vote.”
And at a candidate event in Florence on Saturday, where Graham was expected to speak, some of her supporters said they backed the interim senator’s decision to stay in Washington, even if it meant not campaigning.
“She committed to not missing votes or not being there to push forward with those bills,” said Teresa Castrinos, who made the hours-long drive from Bluffton to see Graham. “I feel like she’s putting South Carolina first. She’s wanting to fulfill her time as a senator right now, so I really admire her for that.”
While Lindsey Graham was single and well known around the world, his sister lived a relatively quiet life with her husband and daughters in Lexington, South Carolina. She spent years in state government, working with people with disabilities and as agency head of the South Carolina Commission for the Blind.
Before participating in a candidate forum Saturday in Florence, her only public campaign event had been a candidate forum in Lexington. Charles Brentnell of Greenville County, who was still considering his options, said he liked her decision to stay in Washington when the Senate was in session.
“Let’s keep the Senate at the Senate instead of taking a month off for no good reason,” he said.
Appearing alongside other contenders Saturday, Graham apologized for reading from notes behind a podium, pointing to the Senate votes that kept her in Washington until just hours before she headed to meet voters in South Carolina.
“Yes, I have some notes. You know why? Because I haven’t slept in two days, so I’m going to keep my thoughts straight,” Graham said, adding that she opposed Senate recess but lost out to others who wanted to end votes and go home. "I wanted to stay there, and I wanted to get things done."
Graham also participated in one of two televised debates, where she backed Trump's plan to change filibuster rules to make it easier to pass strict proof-of-citizenship voting legislation.
While other candidates came to speak to the media gathered afterward, Graham skipped the session and merely gave a thumbs-up outside when asked how she felt the debate had gone.
In contrast to her loquacious late brother, Graham has not spoken with reporters in Capitol Hill hallways or fielded questions on the stump.
She's spoken at length to Fox News personalities Sean Hannity and Trey Gowdy, both of whom eulogized Lindsey Graham at memorial services last month, and granted two interviews to local news outlets.
On Saturday, in her first gaggle with reporters, Graham addressed some of voters' concerns, reiterating her commitment to do Senate work when the chamber is in session.
“I feel like my job is to be in DC working for everyone right now. I hate that I can't be here. I want to be here," she said. "That's why I left and didn't sleep at all last night, so I could attend today's event.”
As to the skepticism in sending Graham to Washington for six years, Graham cited her state government experience, plus the past several weeks she's had serving as interim.
“Trust me, I have learned a lot already, so I think I have experience,” she said.
A second debate took place while Graham was in Washington on Tuesday, a date her campaign pointed out had been scheduled despite the senator’s conflict.
Gigi Bray of Charleston said the idea of Darline Graham serving in the interim makes sense, but electing her to a full term does not.
“I think it’s a great honor for her to hold her brother’s spot till November, but it’s time for a change,” said Bray, who backs Sanford. “I don’t think she has a lot of government experience, and I think right now, with the state of our country, I think it’s very important that somebody has experience.”
Meg Kinnard can be reached at http://x.com/MegKinnardAP
Sen. Darline Graham, R-S.C., center, waits for her turn to speak at a candidate event for hopefuls vying in a special Republican primary to replace her late brother Sen. Lindsey Graham, R-S.C., on November ballots, Saturday, Aug. 8, 2026, in Florence, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., walks across a street to a television studio for a debate with four other Republicans competing in a special Senate primary to replace her brother, Sen. Lindsey Graham, R-S.C., on Monday, Aug. 3, 2026, in Columbia, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., speaks with reporters following at a candidate event for hopefuls vying in a special Republican primary to replace her late brother Sen. Lindsey Graham, R-S.C., on November ballots, Saturday, Aug. 8, 2026, in Florence, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., leans over to hear a reporter's question following at a candidate event for hopefuls vying in a special Republican primary to replace her late brother Sen. Lindsey Graham, R-S.C., on November ballots, Saturday, Aug. 8, 2026, in Florence, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., leaves the stage after speaking at a South Carolina Republican Senate candidate stump event ahead of the special GOP primary to replace her late brother, Sen. Lindsey Graham, R-S.C., Saturday, Aug. 1, 2026, in Lexington, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., speaks with voters following a Senate candidate stump event ahead of a special GOP primary to select a replacement for her late brother, Sen. Lindsey Graham, Saturday, Aug. 1, 2026, in Lexington, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., speaks with voters following a Senate candidate stump event ahead of a special GOP primary to select a replacement for her late brother, Sen. Lindsey Graham, Saturday, Aug. 1, 2026, in Lexington, S.C. (AP Photo/Meg Kinnard)
U.S. Rep. Ralph Norman, R-S.C., addresses a crowd at a campaign event for Republicans vying in a special Senate primary to replace Sen. Lindsey Graham, R-S.C., Thursday, Aug. 6, 2026, in Charleston, S.C. (AP Photo/Meg Kinnard)
Sen. Darline Graham, R-S.C., from left, seated alongside daughter Nicole Nordone and husband Larry Nordone, looks on as a South Carolina Republican Senate candidate stump event gets underway ahead of the special GOP primary to replace her late brother, Sen. Lindsey Graham, R-S.C., Saturday, Aug. 1, 2026, in Lexington, S.C. (AP Photo/Meg Kinnard)
