SANOCHEMIA Pharmazeutika GmbH

NEUFELD, Austria, April 17, 2024 /PRNewswire/ -- Sanochemia Pharmazeutika secures exclusive licensing rights to a new MRI contrast agent based on ferumoxtran, that is in an advanced pivotal trial in clinical phase III and may be used to detect the smallest lymph node metastases in prostate cancer patients. The product is already deployed in the Netherlands within an authorized Named-Patient-Use-Program (Artsenverklaring). Continue Reading Official signing of license deal with Thomas Erkinger and Jürgen Feuerstein The agreement with SPL Medical (Nijmegen, Netherlands) grants Sanochemia exclusive worldwide rights for parts of the manufacture and global distribution of an MRI contrast agent based on ferumoxtran with the exception of the DACH region. The product, which is currently under development in late phase III at several renowned European clinics, shall carry the registered trademark Ferrotran®. Ferrotran® contains iron-based superparamagnetic nanoparticles and is intended to be used to detect even the smallest lymph node metastases in prostate cancer patients. Research is being conducted into the possible use for other types of cancer. Ferrotran® will be the second iron-containing product in Sanochemia's gadolinium-free MRI product range. Only recently, an agreement with b.e.imaging (Baden-Baden, Germany) was announced on the MRI contrast agent Resotran® (ferucarbotran) for the detection of focal liver lesions in adults. "The two agreements mark the start of a new product line," said Sanochemia Managing Director Thomas Erkinger. "We are striving to play a pioneering role in the field of gadolinium-free MRI contrast agents. Innovative specialties optimally complement our classic product line in diagnostic imaging". Both products are based on iron-oxide nanoparticles (USPIO/SPIO: Ultrasmall / Small Superparamagnetic Iron Oxide) and expand the diagnostic options within radiology. Dr. Jürgen Feuerstein, CEO of licensor SPL Medical: "We are gaining access to the worldwide market of medical imaging via the extensive marketing network of Sanochemia. Within an authorized named-patient-use-program, more than 700 prostate cancer patients have already been diagnosed in Nijmegen with ferumoxtran in the Netherlands, enabling them to receive earlier and more specific treatment and a significantly higher chance of recovery. The earlier affected lymph nodes are detected, the better the chances of recovery with targeted, less invasive treatment." Sanochemia Pharmazeutika Sanochemia is a leading supplier of pharmaceuticals for radiological applications in the center of Europe. In addition to classic contrast agents, the company focuses on organ-specific and gadolinium-free specialty products. The company's imaging agents are used by doctors and hospitals in over 50 countries worldwide for diagnostic imaging in MR and CT procedures. At the Austrian production site, more than 200 employees ensure that drug products (FDF) and active pharmaceutical ingredients (APIs) are manufactured to the highest pharmaceutical quality standards. Photo: Logo: SOURCE Sanochemia Pharmazeutika

导语阿尔兹海默病(AD)是一种起病隐匿的进行性发展的神经系统退行性疾病。临床上以“记忆障碍、失语、失用、失认、视空间技能损害、执行功能障碍以及人格和行为改变等全面性痴呆表现为特征，病因迄今未名。65岁以前发病者，称为早老性痴呆；65岁以后发病者称为老年性痴呆。数据显示，世界上有将近5000万人患有阿尔兹海默病或相关的痴呆症，因此研发治疗阿尔兹海默病的治疗药物非常重要。目前全球阿尔兹海默病诊断和治疗市场的复合年增长率为6.7%。推动该市场增长的关键因素是痴呆症等慢性病的患病率上升、加大了治疗阿尔兹海默病药物的研发力度以及增加了诊断早期阿尔兹海默病的医疗器械等。近日美通社发布了2020-2025年全球阿尔兹海默病诊断和治疗市场报告，报告表示胆碱酯酶抑制剂有望占据阿尔兹海默病的最高市场份额。大部分胆碱酯酶抑制剂已获FDA批准，医生和患者也多考虑使用胆碱能药物。另外，还有一些胆碱酯酶抑制剂正在进行临床试验，以提高药物疗效和降低不良反应。因此，我们可以大胆预计胆碱酯酶抑制剂的市场份额有望增长。治疗轻度和中度阿尔兹海默病的一线治疗药物有多奈哌齐(Donepezil)、加兰他敏(galantamine)和利斯的明(rivastigmine)。这三种药物都是胆碱酯酶抑制剂，都是通过阻断乙酰胆碱酯酶来抑制乙酰胆碱的分解，而乙酰胆碱是与记忆有关的重要神经递质。多奈哌齐多奈哌齐(Donepezil)属于六氧吡啶类氧化物，是第二代特异的可逆性中枢乙酰胆碱酯酶(AChE)抑制剂，对外周AChE作用很小。多奈哌齐通过抑制AChE活性，使突触间隙乙酰胆碱(ACh)的分解减慢，从而提高ACh的含量，改善阿尔兹海默病患者的认知功能。化学名称：(±)-2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone截止目前，全球有17个多奈哌齐药物，其中只有1个已上市（Kyukyu Pharmaceutical Co Ltd 研发的多奈哌齐2011年10月在日本以治疗“阿尔兹海默病”上市），2个处于提交上市申请阶段，8个处于临床阶段。表1  多奈哌齐的全球研发现状（截止2021年1月）数据来源：药融云全球药物研发数据库截止目前，CDE共承办148个多奈哌齐的受理号申请，共有26个品种，有56家企业申报。其中，2018年7月重庆植恩药业申报的盐酸多奈哌齐片通过一致性评价。表2  多奈哌齐的中国药品审评情况（截止2021年1月）上下滑动查看更多数据来源：药融云全球药物研发数据库加兰他敏加兰他敏是一种特异性AChE抑制剂，最早由雪花莲的球茎中分离得到，主要用于神经系统疾病及外伤所致的运动障碍，易通过血脑屏障，中枢作用较强。化学名称：6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-ol, 4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)-截止目前，全球有6个加兰他敏药物，其中2个已上市，1个还处于药物发现阶段。Sanochemia Pharmazeutika AG研发的加兰他敏2000年以治疗“阿尔兹海默病”在欧盟和英国上市，Synaptech研发的加兰他敏2005年以治疗“阿尔兹海默病”在美国上市。Sanochemia Pharmazeutika AG研发的加兰他敏近五年的销售额每年都维持在150百万美元左右。表3  加兰他敏的全球研发现状（截止2021年1月）数据来源：药融云全球药物研发数据库截止目前，CDE共承办58个加兰他敏的受理号申请，共有13个品种，有30家企业申报。其中，岳阳新华达制药有限公司申报的氢溴酸加兰他敏和合肥合源药业有限公司申报的氢溴酸加兰他敏还在审评审批中。表4  加兰他敏的中国药品审评情况（截止2021年1月）数据来源：药融云全球药物研发数据库利斯的明利斯的明能同时抑制乙酰胆碱酯酶和丁酰胆碱脂酶，目前已被广泛批准用于治疗轻、中、重度阿尔兹海默病和轻、中度帕金森病痴呆。CAS号：123441-03-2分子式：C14H22N2O2分子量：250.34化学名称：(-)-m-[(S)-1-(dimethylamino)ethyl]phenyl ethylmethylarbamata诺华研发的利斯的明贴片制剂于2007年10月在英国上市，近五年销售额逐年增加，2019年的销售额约82百万美元；而其研发的1997年在瑞士上市的利斯的明胶囊剂，销售额却逐年降低。这是因为利斯的明兼具亲脂性和亲水性的强效小分子特性，极其适用于透皮治疗。而利斯的明透皮贴剂和胶囊剂的疗效相当，不良反应少于胶囊剂。并且透皮贴剂能够为患者提供耐受性、便利性，经皮给药能改善患者的耐受性且更容易达到最佳剂量。截止目前，全球有12个利斯的明药物，其中2个已上市（诺华研发的贴片制剂和胶囊剂），1个处于提交上市申请阶段，3个处于临床阶段，还有2个处于临床前阶段，1个处于药物发现阶段。表5  利斯的明的全球研发现状（截止2021年1月）数据来源：药融云全球药物研发数据库截止目前，CDE共承办34个利斯的明的受理号申请，共有4个品种，有3家企业申报。其中，2020年6月山东绿叶制药申请进口的利斯的明透皮贴剂获批，其视同通过一致性评价。表6  利斯的明的中国药品审评情况（截止2021年1月）数据来源：药融云全球药物研发数据库结语虽然目前任何一种治疗阿尔兹海默病的药物都只能延缓疾病的发展，不能彻底治疗疾病，但是科学家一直在研究阿尔兹海默病的路途上砥砺前行。值得期待的是，科学家正在研究通过编辑人类神经细胞中的关键基因，以改变患阿尔兹海默病的风险。而且香港科技大学等机构的科学家成功揭示了新的治疗阿尔兹海默病的靶点，有望开发新型靶向性疗法。除了药物治疗，家人的陪伴和帮助对于阿尔兹海默病患者至关重要。 版权声明：本文转自药融云，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。 点分享 点点赞点在看

Summary Sanochemia Pharmazeutika AG Sanochemia is a specialty pharmaceutical company that develops and manufactures of innovative drugs in selected indication areas such as neurodegeneration, pain and cancer, as well as diagnostic products based on contrast media. The company's product portfolio includes radiological products including an array of xray imaging agents and the MRT imaging agent; and veterinary pharmaceuticals. It also offers synthesis of active pharmaceutical substances APIs, drug formulation and pharmaceutical production and contract research. Apart from Austria, Sanochemia offers its products in Remaining Europe, Asia, MENA Middle East and North Africa, Commonwealth of Independent States CIS countries and rest of the world. The company has sales offices in Switzerland, Germany, the UK and the US. Sanochemia is headquartered in Vienna, Austria. Sanochemia Pharmazeutika AG SAC Medical Equipment Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Medical eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.