MorphoSys Says Novartis Deal Progressing Steadily Despite Safety Concerns Over Bone Marrow Cancer Drug, Pelabresib
MorphoSys Says Novartis Deal Progressing Steadily Despite Safety Concerns Over Bone Marrow Cancer Drug, Pelabresib
MorphoSys AG (NASDAQ:MOR) is reportedly facing a burgeoning safety concern surrounding pelabresib, an experimental myelofibrosis treatment.
據報道，MorphoSys AG（納斯達克股票代碼：MOR）在實驗性骨髓纖維化治療藥物pelabresib方面正面臨着日益嚴重的安全問題。
Myelofibrosis is a type of blood cancer characterized by the buildup of scar tissue, called "fibrosis," in the bone marrow.
骨髓纖維化是一種血液癌，其特徵是在骨髓中積聚疤痕組織，稱爲 “纖維化”。
Physicians participating in MorphoSys' Phase 3 study have observed instances when patients treated with pelabresib swiftly transitioned from myelofibrosis to acute myeloid leukemia (AML), a more aggressive form of blood cancer.
參與MorphoSys三期研究的醫生觀察到接受pelabresib治療的患者迅速從骨髓纖維化過渡到急性髓系白血病（AML），一種更具侵略性的血液癌的情況。
Citing sources familiar with the cases, STAT News noted physicians saw several instances of patients undergoing such rapid progression.
STAT News援引熟悉這些病例的消息人士的話指出，醫生看到幾例患者病情進展如此之快。
Among 212 patients receiving pelabresib, six serious safety events of "AML transformation" were reported, compared to only two events among 214 patients in the control group.
在212名接受pelabresib治療的患者中，報告了6起嚴重的 “急性髓細胞白血病轉化” 安全事件，而在對照組的214名患者中，只有兩起事件。
Pelabresib has been the centerpiece of MorphoSys' proposed 2.7 billion euro ($2,894,958,900) acquisition by Novartis AG (NYSE:NVS).
Pelabresib一直是諾華股份公司（紐約證券交易所代碼：NVS）提議的27億歐元（合2894,958,900美元）收購MorphoSys的核心。
The deal is expected to close in the first half of 2024.
該交易預計將於2024年上半年完成。
In the deal press release, MorphoSys CEO Jean-Paul Kress said, "Pelabresib — the investigational therapy at the forefront of our promising oncology pipeline — has the potential to shift the treatment paradigm in myelofibrosis and further expand into other indications. Novartis will provide ample resources currently unavailable to MorphoSys as a standalone biotech company to help accelerate the development opportunities and maximize the commercialization potential of pelabresib at a greater speed and scale."
在交易新聞稿中，MorphoSys首席執行官讓-保羅·克雷斯表示：“Pelabresib——我們前景光明的腫瘤學產品線中處於最前沿的研究性療法——有可能改變骨髓纖維化的治療模式，並進一步擴展到其他適應症。作爲一家獨立的生物技術公司，諾華將提供MorphoSys目前無法獲得的充足資源，以幫助加快開發機會，並以更快的速度和規模最大化pelabresib的商業化潛力。”
The FDA was alerted about this imbalance in severe cancer advancements. It issued a cautionary letter to all physicians involved in the study and is closely monitoring the situation.
美國食品和藥物管理局收到了關於嚴重癌症進展中的這種不平衡的警報。它向所有參與這項研究的醫生髮出了警示信，並正在密切關注情況。
Despite this setback, MorphoSys affirmed its acquisition by Novartis is still on track to finalize in the first half of this year.
儘管遇到了挫折，但MorphoSys確認其對諾華的收購仍有望在今年上半年完成。
"We generally do not discuss our interactions with regulatory authorities publicly. We remain confident in the benefit-risk profile of the combination of pelabresib and ruxolitinib," a Morphosys spokesperson said in an emailed response to Reuters.
“我們通常不公開討論我們與監管機構的互動。我們對pelabresib和ruxolitinib組合的收益風險狀況仍然充滿信心。” Morphosys發言人在給路透社的電子郵件回覆中說。
"The planned acquisition by Novartis is progressing steadily," they added.
他們補充說：“諾華的收購計劃正在穩步進行。”
In November, the company released topline results from the Phase 3 MANIFEST-2 study investigating pelabresib in combination with the JAK inhibitor ruxolitinib compared with placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis.
11月，該公司發佈了3期 MANIFEST-2 研究的主要結果，該研究調查了pelabresib與JAK抑制劑ruxolitinib聯合使用與安慰劑加魯索利替尼對比對照組合 JAK 抑制劑天真的骨髓纖維化患者。
MOR Price Action: MorphoSys shares are down 3.38% at $17.43 at publication Monday.
MOR價格走勢：週一公佈時，MorphoSys股價下跌3.38％，至17.43美元。
Photo: PublicDomainPictures from Pixabay
照片：Pixabay 的 PublicDomainPicture
譯文內容由第三人軟體翻譯。