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.
据报道，MorphoSys AG（纳斯达克股票代码：MOR）在实验性骨髓纤维化治疗药物pelabresib方面正面临着日益严重的安全问题。
Myelofibrosis is a type of blood cancer characterized by the buildup of scar tissue, called "fibrosis," in the bone marrow.
骨髓纤维化是一种血液癌，其特征是在骨髓中积聚疤痕组织，称为 “纤维化”。
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.
参与MorphoSys三期研究的医生观察到接受pelabresib治疗的患者迅速从骨髓纤维化过渡到急性髓系白血病（AML），一种更具侵略性的血液癌的情况。
Citing sources familiar with the cases, STAT News noted physicians saw several instances of patients undergoing such rapid progression.
STAT News援引熟悉这些病例的消息人士的话指出，医生看到几例患者病情进展如此之快。
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治疗的患者中，报告了6起严重的 “急性髓细胞白血病转化” 安全事件，而在对照组的214名患者中，只有两起事件。
Pelabresib has been the centerpiece of MorphoSys' proposed 2.7 billion euro ($2,894,958,900) acquisition by Novartis AG (NYSE:NVS).
Pelabresib一直是诺华股份公司（纽约证券交易所代码：NVS）提议的27亿欧元（合2894,958,900美元）收购MorphoSys的核心。
The deal is expected to close in the first half of 2024.
该交易预计将于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."
在交易新闻稿中，MorphoSys首席执行官让-保罗·克雷斯表示：“Pelabresib——我们前景光明的肿瘤学产品线中处于最前沿的研究性疗法——有可能改变骨髓纤维化的治疗模式，并进一步扩展到其他适应症。作为一家独立的生物技术公司，诺华将提供MorphoSys目前无法获得的充足资源，以帮助加快开发机会，并以更快的速度和规模最大化pelabresib的商业化潜力。”
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.
美国食品和药物管理局收到了关于严重癌症进展中的这种不平衡的警报。它向所有参与这项研究的医生发出了警示信，并正在密切关注情况。
Despite this setback, MorphoSys affirmed its acquisition by Novartis is still on track to finalize in the first half of this year.
尽管遇到了挫折，但MorphoSys确认其对诺华的收购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.
“我们通常不公开讨论我们与监管机构的互动。我们对pelabresib和ruxolitinib组合的收益风险状况仍然充满信心。” Morphosys发言人在给路透社的电子邮件回复中说。
"The planned acquisition by Novartis is progressing steadily," they added.
他们补充说：“诺华的收购计划正在稳步进行。”
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，该公司发布了3期 MANIFEST-2 研究的主要结果，该研究调查了pelabresib与JAK抑制剂ruxolitinib联合使用与安慰剂加鲁索利替尼对比对照组合 JAK 抑制剂天真的骨髓纤维化患者。
MOR Price Action: MorphoSys shares are down 3.38% at $17.43 at publication Monday.
MOR价格走势：周一公布时，MorphoSys股价下跌3.38％，至17.43美元。
Photo: PublicDomainPictures from Pixabay
照片：Pixabay 的 PublicDomainPicture
译文内容由第三方软件翻译。