維也納--(BUSINESS WIRE)--四月 25, 2026--
(美國商業資訊)-- 今天，法蘭克福高等地區法院維持了2025年2月 1 國際商會國際仲裁院（ICC）就AOP Orphan Pharmaceuticals GmbH（AOP Health）與PharmaEssentia Corp.（PharmaEssentia）之間爭議所作出的部分終局裁決。該裁決確認了原裁決，認定這家台灣公司須就特定損害賠償承擔責任。
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AOP Health兩位創辦人之一的Rudolf Widmann博士解釋道：「 我們樂見法蘭克福高等地區法院的裁決，該裁決確認了我們的立場。為了患者的利益，我們致力於維持BESREMi®的穩定和持續供應，並以負責任的態度因應未來的挑戰。 」
爭議產品
這項爭議的焦點在於BESREMi®（羅培干擾素α-2b），該產品於2019年上市，是由AOP Health透過一項全面臨床試驗計畫開發的一種用於治療罕見血癌（尤其是真性紅血球增生症）的創新療法。如主要相關指引 2 所記載，BESREMi®成為此適應症臨床試驗中研究最為深入的干擾素。2009年，AOP Health從PharmaEssentia手中收購了BESREMi®在歐洲、獨立國協（CIS）和中東市場的開發和商業化權利。在獲得歐洲藥品管理局（EMA）批准後的第七年，AOP Health已成功在其授權區域內為約12,600名患者提供BESREMi®。
首次仲裁和撤銷程序
自2017年以來，PharmaEssentia多次試圖終止與AOP Health就BESREMi®達成的協議。2020年10月，國際商會國際仲裁院駁回了這些請求，並裁定PharmaEssentia向AOP Health支付約1.43億歐元的賠償金，同時駁回了PharmaEssentia的所有反訴。
後續的撤銷程序確認了仲裁裁決的基本內容，但發現損害賠償金額的計算有程序性缺陷，影響了最終裁定的賠償金額。
第二次仲裁
2020年11月，PharmaEssentia對AOP Health提起訴訟，提出損害賠償請求。AOP Health則反過來指控PharmaEssentia延誤了BESREMi®在歐洲的審批，並濫用AOP Health的臨床試驗資料以獲得PharmaEssentia在美國的上市許可，並要求PharmaEssentia賠償損失。最終，國際商會國際仲裁院於2025年2月17日作出部分最終裁決，支持AOP Health的訴求，認定PharmaEssentia存在故意違約行為，並需承擔多項賠償責任。仲裁院尚未就賠償金額作出裁決。
法蘭克福高等地區法院裁決確認AOP Health的立場
2025年5月，PharmaEssentia向法蘭克福高等地區法院提出申請，要求撤銷國際商會國際仲裁院於2025年2月10日所做的部分最終裁決。PharmaEssentia提出的理由包括該裁決違反公共秩序，並侵犯了其申辯權。
2026年4月24日，法蘭克福高等地區法院駁回了PharmaEssentia的全部申請，並宣布該裁決有效。PharmaEssentia可向德國聯邦最高法院提起上訴。
AOP Health認為，該裁決確認了其立場，並強化了其對患者的承諾。公司將繼續為需要羅培干擾素α-2b（BESREMi®）的患者供藥，並維持患者所倚賴的高品質標準。
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。
有關歐洲藥品管理局（EMA）公布的產品特性摘要，請造訪：BESREMi®
關於AOP Health
AOP Orphan Pharmaceuticals GmbH（簡稱「AOP Health」）總部位於奧地利，是一家扎根於該國的全球性醫療保健集團。自1996年以來，AOP Health Group一直致力於開發創新的解決方案，以解決尚未被滿足的醫療需求，特別是在罕見疾病和重症醫學領域。
2024年底，AOP Health針對重症加護病房病患的藥物Rapiblyk™首度獲得美國食品藥物管理局（FDA）核准，進一步鞏固了其為全球病患提供治療方案的承諾。AOP Health Group已成為國際上整合療法解決方案的先驅，並透過子公司、代表處和強大的合作夥伴網路在全球營運。
AOP Health Group以 「需求、科學、信任。」(Needs. Science. Trust.) 為宗旨，強調了其對研究與發展的承諾，以及與醫師和病患權益團體建立關係的重要性，從而確保這些利害關係人的需求能在AOP Health Group各方面的行動中得到體現。
1https://www.aop-health.com/global_en/press/press-releases/icc-arbitral-tribunal-ruling-aop-health/
2 ELN Guideline (2022), NCCN Guideline (2024), Onkopedia Leitlinie (2023)
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CONTACT: 如需進一步查詢有關事宜：
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Nina.Roth@aop-health.com
+43-676-3131509
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SOURCE: AOP Orphan Pharmaceuticals GmbH
Copyright Business Wire 2026.
PUB: 04/25/2026 04:57 AM/DISC: 04/25/2026 04:57 AM
http://www.businesswire.com/news/home/20260424529299/zh
AOP Health創辦人Rudolf Widmann博士，照片來源：AOP Health/Daniel Ospelt
PORTSMOUTH, Va. (AP) — When President Donald Trump tried to cancel five massive offshore wind projects under construction along the East Coast, it wasn't just environmentalists who cried foul. Nine Republicans in the U.S. House sent a letter to administration officials demanding an explanation.
“America’s energy policy should be grounded in facts, fiscal responsibility, and the national interest — not ideology or politics,″ they wrote.
One of the lawmakers is Rep. Jen Kiggans, a former Navy helicopter pilot who represents a coastal district in Virginia where an $11.5 billion wind farm is expected to create 1,000 jobs. Her support for an initiative targeted by Trump shows the scrambled politics of clean energy in an election year where Republicans are at risk of losing the House.
Kiggans could be even more at risk after Virginia voters on Tuesday approved a new congressional map that makes her competitive district more Democratic than before.
Trump's broader campaign against clean energy resulted in the cancellation of nearly $35 billion in U.S. projects last year, according to a report by E2, a clean energy business group. Republican-held congressional districts lost nearly twice as much in investments than did Democratic districts, the report said.
For now, the Virginia project is back on track, along with the other four, because of federal court rulings. But Elaine Luria, a former congresswoman who is seeking the Democratic nomination in the 2nd Congressional District represented by Kiggans, said the incumbent's efforts have been futile in the face of Trump’s onslaught.
“Her advocacy did nothing," Luria said. Kiggans did not respond to requests for comment.
Trump has treated energy issues as another front in the nation's cultural clashes, referring to Democrats' support for clean energy as the “Green New Scam.” He frequently talks about his hatred of “windmills,” which he described as “STUPID AND UGLY” on social media. He issued an executive order on the first day of his second term blocking wind projects and he has insisted that “smart countries” do not use wind power.
Solar farms are not much better in his mind.
“You go around and you see all these things that are 3 miles long by 3 miles wide and you say what the hell is that,” Trump said at the White House last summer.
The administration even agreed to pay $1 billion to a French company to walk away from two U.S. offshore wind leases and instead invest in oil and natural gas projects.
Kiggans voted in favor of Republican legislation to gut clean energy tax credits as part of Trump’s sweeping tax and spending bill even though she has long portrayed herself as a champion of renewable energy. Democrats have turned the issue into campaign advertisements, and Luria said it undermines Kiggans' attempt to “sell herself as if she's a moderate.”
Luria said Kiggans “voted for a bill to make energy more expensive.”
In a Facebook post after the bill was passed in July, Kiggans said her vote “wasn’t about politics — it was about overall results.”
“I had ONE vote, and I voted YES on the One Big Beautiful Bill Act not because it was perfect but because it delivers permanent tax relief for families & small businesses, rebuilds our Navy & invests in national defense," she wrote.
Stephen Farnsworth, a political science professor at the University of Mary Washington in Fredericksburg, Virginia, said front-line Republicans have been put in a difficult position.
“Kiggans is not the only Republican being squeezed" as Trump focuses on his own priorities and the country faces economic headwinds exacerbated by the war with Iran, he said. Although few want to risk upsetting the president, Farnsworth said, “in coastal Virginia politics, there’s not much upside to opposing wind."
U.S. Rep. Tom Kean Jr., R-N.J., has been caught up in a controversy over the Gateway Tunnel, which will add new rail tracks under the Hudson River to alleviate congestion between his state and New York City. Trump tried to block federal funding, a potential setback for commuters in towns that Kean represents. A judge ordered the administration to restore money for the project after Democratic leaders in New Jersey and New York went to court.
Although Trump has dismissed offshore wind turbines as ugly, the Coastal Virginia Offshore Wind project is about 27 miles (43 kilometers) out into the ocean, making it difficult to see from land. On a recent visit to the Portsmouth Marine Terminal, where construction is staged, the turbines were impossible to discern along the horizon.
Dominion Energy, which operates the wind farm, says it delivered its first power to the grid last month. The project, first announced in 2013, is expected to create 1,000 jobs and generate about $2 billion in economic activity, the company said.
Once finished, the 176-turbine project could deliver 2.6 gigawatts of power to the grid — enough to supply more than 660,000 homes — at a time when Virginia faces growing energy demand from an expanding hub of artificial intelligence data centers.
“There's an opportunity here for Hampton Roads to be a national leader in offshore wind,'' said Andrew Nissman, a spokesman for the Hampton Roads Workforce Council, which has trained maritime workers for the project.
Nissman declined to comment on the congressional race, saying, ”as with any stop-and-start challenge, it's important the project is moving forward.''
While the wind farm is now partially online, "Kiggans nearly cost her constituents this project by standing with an administration dead set on dismantling the offshore wind industry and voting to repeal critical clean energy tax credits last year,'' said Dan Taylor, Southeast regional field manager for the BlueGreen Alliance, which coordinates labor unions and environmental groups.
“Kiggans claims to prioritize jobs, lower energy costs for Virginians and reducing emissions,” Taylor added. “Yet she voted to kill jobs, skyrocket energy costs to families and increase the emissions driving climate change.”
FILE - Two offshore wind turbines are seen off the coast of Virginia Beach, Va., on June 29, 2020. (AP Photo/Steve Helber, File)
FILE - Rep. Jen Kiggans, R-Va., speaks at a House GOP news conference, March 5, 2026, in Washington. (AP Photo/Allison Robbert, File)
Former Rep. Elaine Luria, D-Va., poses for a photo near the Dominion Energy Offshore Wind Farm staging area Monday, April 13, 2026, in Portsmouth, Va. (AP Photo/Julia Demaree Nikhinson)
The Dominion Energy Offshore Wind Farm staging area is seen at the Portsmouth Marine terminal Monday, April 13, 2026, in Portsmouth, Va. (AP Photo/Julia Demaree Nikhinson)
