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药物制造商Norgine将收购Theravia,加强罕见病产品组合

Norgine strengthens rare disease portfolio with acquisition of Theravia

CISION 等信源发布 2025-04-15 14:01

可切换为仅中文


Acquisition of Theravia from Mérieux Equity Partners represents meaningful step forward in Norgine's strategy for sustainable growth, adding a complementary portfolio of rare disease medicines

从梅里厄克斯股权合作伙伴收购Theravia代表了Norgine在可持续发展战略中迈出的重要一步,增加了一个互补的罕见病药物组合。

Transaction further establishes Norgine's position as a partner of choice for commercialising rare and specialty pharmaceuticals in

该交易进一步确立了Norgine作为罕见病和专科药物商业化的首选合作伙伴的地位。

Europe

欧洲

PARIS

巴黎

,

April 15, 2025

2025年4月15日

/PRNewswire/ --

/PRNewswire/ --

Norgine and Theravia

诺吉内和特拉维亚

announced today that they have entered into a definitive agreement under which Norgine will acquire Theravia, an international pharmaceutical company specialising in cutting-edge treatments for patients with rare and debilitating conditions.

今天宣布,他们已经达成了一项最终协议,根据该协议,Norgine将收购专注于为罕见和衰弱疾病患者提供前沿治疗的国际制药公司Theravia。

Recent deals with Fennec Pharma for PEDMARQSI

最近与Fennec制药公司达成的PEDMARQSI交易

®

®

and X4 Pharma for mavorixafor demonstrate Norgine's strong emphasis on driving growth in rare disease and specialty medicines through acquisitions and in-licensing.

通过收购和授权引进,Norgine 强调了其对推动罕见病和专科药物增长的高度重视,例如与 X4 制药合作的 mavorixafor 项目。

Theravia's innovations have resulted in successful launches of life-saving medications which have changed patient outcomes worldwide. Theravia has several products in the rare disease space, including SIKLOS

Theravia的创新成果促成了挽救生命的药物的成功上市,这些药物改变了全球患者的治疗结果。Theravia在罕见病领域拥有多种产品,包括SIKLOS。

®

®

, for adults and children with sickle cell disease, and ORPHACOL

,适用于患有镰状细胞病的成人和儿童,以及ORPHACOL

®

®

, a medicine for adults and children who have a genetic disorder that affects bile production by the liver. These products span both the rare haematology and rare hepatology therapeutic areas and are complementary to Norgine's existing rare and specialty portfolio. The development of Theravia in the past few years has been supported by its majority shareholder Mérieux Equity Partners, a healthcare dedicated investment firm based in .

,一种用于治疗成人和儿童因遗传性疾病导致肝脏胆汁生成受影响的药物。这些产品横跨罕见血液病和罕见肝病治疗领域,与Norgine现有的罕见病和专科药物组合相辅相成。Theravia在过去几年的发展中得到了其大股东梅里厄股权投资伙伴(Mérieux Equity Partners)的支持,这是一家总部位于 的专注医疗保健的投资公司。

France

法国

.

'

'

This acquisition is a unique opportunity for Norgine to bolster our growth trajectory, as well as our rare disease portfolio.'

此次收购是Norgine提升我们增长轨迹以及罕见病药物组合的独特机会。

said Janneke van der Kamp, Chief Executive Officer, Norgine. '

诺吉尼首席执行官扬内克·范·德·坎普说。'

With our strong legacy and proven track record of successfully bringing innovative treatments to patients, we believe we are well placed to ensure the Theravia medicines reach their full potential.'

凭借我们强大的传承和成功为患者带来创新治疗的可靠记录,我们相信我们有能力确保Theravia药物充分发挥其潜力。

Franck Hamalian, Chief Executive Officer, Theravia, added:

法兰克·哈马利安,Theravia首席执行官,补充道:

'The joining of our companies brings together the skills, know-how and geographical presence that will create a European-based champion of rare and ultra rare disease. Our combined product portfolios and Norgine's legacy and experience will enable broader access to medicines for patients with high unmet medical needs.'.

“我们公司的合并汇集了技能、专业知识和地域优势,这将打造一家专注于罕见病和超罕见病的欧洲领军企业。我们合并后的产品组合以及Norgine的传统和经验,将使医疗需求高度未满足的患者获得更广泛的药物获取途径。”

With the acquisition of Theravia, Norgine will now have six core products in its rare disease portfolio (PEDMARQSI

通过收购Theravia,Norgine现在将在其罕见病产品组合中拥有六种核心产品(PEDMARQSI)

®

®

, eflornithine, mavorixafor, AGILUS

,依氟鸟氨酸、马沃利克索、AGILUS

®

®

, SIKLOS

,西克洛斯

®

®

and ORPHACOL

和 ORPHACOL

®

®

) thereby comprising a franchise of critical scale with the ability to be a key growth driver in the medium-to-long-term.

)从而构成一个具有关键规模的特许经营权,有能力成为中长期的关键增长动力。

Norgine looks forward to building on this transaction as we continue to strengthen our platform for future acquisitions and in-licensing opportunities to drive growth.

诺尔金期待着在此交易的基础上继续发展,我们将继续加强平台建设,为未来的收购和许可机会提供支持,以推动增长。

The transaction remains subject to obtaining customary regulatory approvals from the competent authorities.

该交易仍有待获得相关主管部门的常规监管批准。

Notes

笔记

About Theravia

关于Theravia

Theravia is an international pharmaceutical laboratory specializing in rare or neglected diseases. Formed through the merger of Addmedica and CTRS, Theravia is dedicated to addressing the unmet medical needs of patients with these challenging conditions.

Theravia是一家专注于罕见病或被忽视疾病的国际制药实验室。由Addmedica和CTRS合并而成,Theravia致力于满足这些具有挑战性疾病的患者未被满足的医疗需求。

About SIKLOS

关于SIKLOS

®

®

SIKLOS

西克洛斯

®

®

is used in adults, adolescents and children over two years of age who have sickle-cell syndrome, a genetic disease where the red blood cells become rigid and sticky and change from being disc-shaped to being crescent-shaped (like a sickle). It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ.

用于治疗患有镰状细胞综合征的成人、青少年和两岁以上的儿童,镰状细胞综合征是一种遗传性疾病,患者的红细胞变得僵硬且粘稠,并从圆盘状变为新月形(如镰刀)。它被用来预防由于异常红细胞堵塞血管、限制血液流向器官而导致的反复发作的疼痛性血管阻塞性危机。

They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X-ray..

它们可以包括急性胸部综合症,这是一种危及生命的状况,当患者突然出现胸痛、发烧、呼吸困难或X光片显示肺部有液体迹象时。

SIKLOS

西克洛斯

®

®

is marketed in 17 countries around the world.

在全球17个国家销售。

About ORPHACOL

关于ORPHACOL

®

®

ORPHACOL

ORPHACOL

®

®

is a medicine containing cholic acid, a substance found in the bile, which is used to digest fats. It is approved in the US and

是一种含有胆酸的药物,胆酸是胆汁中的一种物质,用于消化脂肪。它已在美国获得批准并且

Europe

欧洲

used to treat adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile. The therapy is used in patients who do not have enough of two specific liver enzymes which makes their liver unable to produce enough of the main components of bile, called primary bile acids, such as cholic acid.

用于治疗从一个月大开始因基因异常而无法产生胆汁的成人和儿童。该疗法适用于缺乏两种特定肝酶的患者,这些酶的不足使他们的肝脏无法产生足够的胆汁主要成分,即初级胆汁酸(如胆酸)。

When these primary bile acids are lacking, the body produces abnormal bile acids instead which can damage the liver, potentially leading to life-threatening liver failure..

当这些初级胆汁酸缺乏时,身体会产生异常的胆汁酸,这可能会损害肝脏,甚至导致危及生命的肝衰竭。

ORPHACOL

ORPHACOL

®

®

is marketed in 23 countries around the world.

在全球 23 个国家销售。

About PEDMARQSI

关于PEDMARQSI

®

®

PEDMARQSI

PEDMARQSI

®

®

is a novel formulation of anhydrous sodium thiosulfate, specifically developed and manufactured for the prevention of cisplatin-induced hearing loss in patients 1 month to <18 years of age. It is the first and only preventative treatment developed for cisplatin-induced ototoxicity to support children and adolescent patients with localised, non-metastatic solid tumour cancers..

是一种无水硫代硫酸钠的新配方,专门开发并生产用于预防1个月至18岁以下患者顺铂诱发的听力损失。这是首个也是唯一一个为预防顺铂诱发的耳毒性而开发的治疗方法,旨在支持患有局部非转移性实体肿瘤的儿童和青少年患者。

It was granted marketing authorisation by the EMA in

它被欧洲药品管理局授予上市许可

May 2023

2023年5月

(under the paediatric-use marketing authorisation (PUMA) programme) and the MHRA in

(在儿科使用营销授权(PUMA)计划下)以及MHRA在

October 2023

2023年10月

.

About Mavorixafor

关于Mavorixafor

Mavorixafor is a selective CXCR4 receptor antagonist approved in the U.S. and marketed by X4 as XOLREMDI

Mavorixafor 是一种选择性的 CXCR4 受体拮抗剂,已在美国获批,并由 X4 公司以 XOLREMDI 的名称销售。

®

®

, an oral, once-daily treatment for patients 12 years of age and older with WHIM syndrome, a rare primary immunodeficiency.

,一种口服、每日一次的治疗方案,适用于12岁及以上WHIM综合征患者,这是一种罕见的原发性免疫缺陷。

In

January 2025

2025年1月

, X4 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for mavorixafor for the treatment of WHIM syndrome, for which it has been granted Orphan Drug Designation by both the EMA and the U.S. Food and Drug Administration.

X4 向欧洲药品管理局 (EMA) 提交了 mavorixafor 用于治疗 WHIM 综合征的上市许可申请 (MAA),该药物已获得 EMA 和美国食品药品监督管理局的孤儿药资格认定。

X4 is also developing the medicine to treat chronic neutropenia (CN) and is currently conducting a global, pivotal Phase 3 clinical trial in certain CN disorders. Norgine has responsibility for commercialisation in

X4 还在开发治疗慢性中性粒细胞减少症 (CN) 的药物,并正在针对某些 CN 疾病进行一项全球关键的 3 期临床试验。Norgine 负责商业化工作。

Europe

欧洲

,

Australia

澳大利亚

, and

,以及

New Zealand

新西兰

following regulatory approvals.

以下监管批准。

About Eflornithine

关于依氟鸟氨酸

Eflornithine has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy. It is a targeted therapy that blocks an enzyme called ornithine decarboxylase (ODC), responsible for producing polyamines, which are important to tumour growth and development..

Eflornithine 已被研究用于高风险神经母细胞瘤(HRNB)的维持治疗后的治疗,针对一线多药、多模式治疗后无活动性疾病(NAD)/无疾病证据(NED)的儿科患者。它是一种靶向治疗,可阻断一种称为鸟氨酸脱羧酶(ODC)的酶,该酶负责生成对肿瘤生长和发育重要的多胺类物质。

The medicine is approved by the FDA for a maintenance therapy for high-risk neuroblastoma in adult and pediatric patients. In

该药物被FDA批准用于成人和儿童高风险神经母细胞瘤的维持治疗。

April 2024

2024年4月

, an application for approval was submitted by Norgine for the use of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in

,Norgine公司通过Orbis项目提交了关于依氟鸟氨酸用于高风险神经母细胞瘤(HRNB)的使用申请。

Australia

澳大利亚

,

Switzerland

瑞士

and the

United Kingdom

英国

. In

。在

January 2025

2025年1月

, a marketing authorisation application was filed to the European Medicines Agency (EMA) for the medicine in high-risk neuroblastoma (HRNB).

,针对高风险神经母细胞瘤(HRNB)的药物已向欧洲药品管理局(EMA)提交了上市许可申请。

About AGILUS®

关于AGILUS®

AGILUS

AGILUS

®

®

is a medicine used to treat malignant hyperthermia (rapid rise in body temperature caused by uncontrolled muscle contractions) in adults and children. Malignant hyperthermia is a serious reaction to certain medicines used for general anaesthesia during surgery or other medical procedures.

是一种用于治疗成人和儿童恶性高热(因肌肉无法控制收缩而引起的体温快速升高)的药物。恶性高热是对在手术或其他医疗程序中用于全身麻醉的某些药物产生的严重反应。

AGILUS

AGILUS

®

®

is approved for use by the EMA for for the treatment of malignant hyperthermia in adults and children in combination with adequate support measures.

获欧洲药品管理局 (EMA) 批准用于成人和儿童恶性高热的治疗,结合充分的支持措施。

About Mérieux Equity Partners

关于Mérieux股权投资合作伙伴

Founded in 2009, Mérieux Equity Partners ('MxEP') is a leading European healthcare-specialized investment firm, with two dedicated platforms, Venture Capital and Buyout, supporting companies ranging from start-ups to established leaders. Benefiting from a longstanding expertise and a large network, MxEP invests in companies with ambitious growth projects and transformative products or services in healthcare.

成立于2009年的梅里厄股权投资合伙人公司(Mérieux Equity Partners,简称MxEP)是一家领先的欧洲医疗保健专业投资公司,拥有两个专用平台:风险资本和收购,支持从初创企业到成熟领导者的各类公司。凭借长期的专业知识和广泛的网络,MxEP投资于那些在医疗保健领域拥有雄心勃勃的增长计划和变革性产品或服务的公司。

MxEP is AMF-accredited and currently manages c.€1.5bn of AuM..

MxEP 获得了 AMF 认证,目前管理着约 15 亿欧元的资产。

About Norgine

关于Norgine

Norgine is a uniquely positioned, specialty pharmaceutical and consumer healthcare company, with over €550 million of annual revenues and a 120-year track record of bringing life-changing products to patients and consumers across our core markets of

诺尔金是一家独特定位的专业制药和消费者保健公司,年收入超过5.5亿欧元,并在我们核心市场拥有120年为患者和消费者带来改变生活的产品的记录。

Western Europe

西欧

,

Australia

澳大利亚

and

New Zealand

新西兰

.

Norgine's integrated approach – strong commercial capabilities, as well as deep medical, regulatory and clinical expertise, in-house manufacturing, robust supply networks, and best-in-class enabling functions – ensures that Norgine can deliver high-quality, transformative medicines quickly and effectively to over 25 million patients annually..

Norgine的综合方法——强大的商业能力,以及深厚的医学、监管和临床专业知识,内部制造,强大的供应网络和一流的辅助功能——确保Norgine能够快速有效地将高质量、变革性的药物每年交付给超过2500万患者。

Norgine is a nimble, innovative, and high-performing company that has been transformed by a relentless focus on operational excellence. This focus will enable us to secure the legacy of more than a century of innovation and doing the right thing by our patients, as we push the boundaries and take strides into therapeutic innovation..

诺尔金是一家灵活、创新且高效的企业,通过始终专注于运营卓越性,公司实现了转型。这一专注将使我们能够确保一个多世纪以来的创新遗产,并在我们突破界限、大步迈向治疗创新时,继续为患者做正确的事情。

NORGINE and the sail logo are trademarks of the Norgine group of companies.

NORGINE 和帆船标志是 Norgine 集团公司的商标。

Logo -

标志 -

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