Eslicarbazepine Acetate

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 6,000 employees worldwide. Sumitomo Pharma defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. CorpComms@us.sumitomo-pharma.com View original content to download multimedia: SOURCE Sumitomo Pharma America, Inc.

关注并星标CPHI制药在线系列文章：《闲聊2023年度可能获批的重磅仿制药（一）》《闲聊2023年度可能获批的重磅仿制药（二）》       本部分介绍的是以3类仿制药申报的候选首仿药，具体情况依次如下：       01-酒石酸阿福特罗雾化吸入溶液       酒石酸阿福特罗雾化吸入溶液一种长效β2受体激动剂，用于治疗慢性阻塞性肺病（COPD）。       酒石酸阿福特罗雾化吸入溶液原研厂家为Sunovion制药，商品名为Brovana，该产品最早于2006年获得FDA批准，原研产品暂未进入中国市场销售。       公开数据显示，2017年，酒石酸阿福特罗雾化吸入溶液（Brovana）销售额大约为3亿美元。       2021年3月，酒石酸阿福特罗雾化吸入用溶液被国家纳入第2批鼓励仿制药目录，目前国内有正大天晴、江苏长泰药业和江苏和晨药业以仿制药3类申报，正大天晴于2019年11月29日提交酒石酸阿福特罗雾化吸入用溶液申请，是首家进行申报的企业，有望拿下该产品的首仿。（详见图1）       图1 酒石酸阿福特罗雾化吸入用溶液注册进展（源自CDE数据库）       02-醋酸艾司利卡西平片       醋酸艾司利卡西平是S (+)-利卡西平醋酸酯前药，是现有抗癫痫药物奥卡西平(Trileptal)的活性代谢物，它通过阻断动作电位的传导，以抑制脑神经元的反复异常放电，控制癫痫发作。该药长期给药耐受性好，疗效和安全性较高       醋酸艾司利卡西平原研是由Bial-Portela、卫材（Eisai）和日本住友（Dainippon Sumitomo）联合开发，最早于2009年在欧洲获批，商品名为Zebinix。2013年11月Sunovion 公司的醋酸艾司利卡西平在美国获批，商品名为Aptiom，批准其用于局灶性癫痫发作辅助治疗，并在2015年将适应证扩大至局灶性癫痫发作的单一药物治疗。目前醋酸艾司利卡西平片原研在国内未获批上市。       据公开数据显示，2019 年该药物全球销售额为 2.75 亿美元。另外2020年4月至2021年3月的12个月,醋酸艾司利卡西平制剂全球销售额为4.4亿美元,同比增长10.3%。       2021年3月醋酸艾司利卡西平片被我国纳入第二批鼓励仿制药品目录中。目前，国内已由多家企业布局艾司利卡西平仿制药市场。北京四环制药是首家仿制申报企业，并在2019年3月以"儿童用药"为由纳入优先审评， 但是扬子江药业注册进度后来居上，谁将率先拿下首仿，我们拭目以待。（详见图2）       另外，2021年9月22日，上药集团下属控股子公司上海上药中西制药的醋酸艾司利卡西平片ANDA已获得美国FDA的暂时批准。       图2 醋酸艾司利卡西平片注册进展（源自CDE数据库）       03-环孢素眼用乳剂       环孢素是由11个氨基酸残基组成的环状多肽药物，因其具有优异的免疫抑制效果，最初被用于器官移植后的免疫抑制。环孢素眼用乳剂是一种含有0.05%浓度环孢素的滴眼液，主要用于干燥性角膜结膜炎相关的眼部炎症。       环孢素眼用乳剂原研是美国艾尔健公司，2002 年12月，艾尔健公司的环孢素眼用乳剂（商品名：Restasis）上市，是全球首个上市的治疗干眼症的环孢素制剂。目前环孢素眼用乳剂原研在国内未获批上市。       据公开数据显示，自Restasis上市后，2003-2016 年销售额复合增速高达32.59%，2016 年实现峰值销售14.88 亿美元，之后Restasis的销售额趋于平稳。近年来随着诺华收购日本武田的干眼症药物Xiidra（Xiidra原本是Shire的重磅眼科药物，2019年1月被武田制药收购），Restasis的市场份额逐渐减少，2020年销售额一路下滑至7.87亿美元。       国内环孢素眼用乳剂竞争药企较少，目前只有江西科伦药业提交了环孢素眼用乳剂的仿制药申请，有望斩获该品种国内首仿药。（详见图3）       图3 环孢素眼用乳剂注册进展（源自CDE数据库）       04-氨己烯酸片       氨己烯酸是一种抗癫痫药，它是GABA氨基转移酶的抑制剂，具有高度的选择性，对耐药性的部分发作型癫痫特别有效，对继发的全面性癫痫发作疗效差。临床上用于治疗其他抗癫痫药无效的癫痫，特别是部分性发作。还可治疗婴儿痉挛症(韦斯特综合征、West综合征)，属于罕见病药物。       氨己烯酸最早是由美国Merrell Dow公司研发，1989年首先在英国上市，用于部分性及全身性癫痫发作的治疗，其专利权属于Ovation公司。2009年3月，灵北（H.LundbeckA/S）公司收购了Ovation公司。2009年8月LUNDBECK的氨己烯酸片(商品名：Sabril)以孤儿药身份在美国获批，用于婴儿痉挛症治疗药和成人复杂难治性癫痫部分发作的辅助治疗药。       2000年国内曾有企业申请进口，但最终未获批准。2019年10月，氨己烯酸片入选国家第一批鼓励仿制药品目录。目前只有远大医药（中国）于2019年1月提交了氨己烯酸片的仿制药申请，而且2019年3月以"罕见病"为由纳入优先审评，远大医药有望迎来该品种国内首仿药上市。（详见图4）       图4 氨已烯酸片注册进展（源自CDE数据库）       05-奥贝胆酸片       奥贝胆酸是法尼酯X核受体（FXR）的强效激动药，其可通过活化法尼醇X受体，间接抑制细胞色素7A1（CYP7A1）的基因表达，增强FGF-19的表达。奥贝胆酸是近20年来首 个研发用于治疗PBC的药物，可抑制胆酸合成，用于治疗原发性胆汁性肝硬化（PBC）、非酒精性脂肪性肝病（NASH）、原发性硬化性胆管炎。       奥贝胆酸由美国Intercept 制药公司研发，2016年5月，奥贝胆酸获得美国 FDA 批准上市，用于治疗原发性胆汁性肝硬化。2016 年 12 月，奥贝胆酸获得欧盟批准上市，后陆续在加拿大、澳大利亚等国家获批上市。另外奥贝胆酸还于2010年获得欧洲药品管理局孤儿药委员会（COMP）的孤儿药资格认定。       自上市以来，奥贝胆酸在全球销售额呈现不断增长态势，获批上市后首年销售额约1800万美元，2018年就达到约1.78亿美元，增长近10倍，2019年奥贝胆酸销售额为2.5亿美元， 2020年奥贝胆酸全球销售额已达到3.1亿美元，同比增长24.8%。目前原研厂家的产品还未在国内上市。       国内布局奥贝胆酸片的药企不少，包括正大天晴、江苏恒瑞、上海复旦张江、华润三九、成都倍特、扬子江药业、四川科伦、苏州泽璟生物等，2021年3月，奥贝胆酸入选我国第二批鼓励仿制药品目录。2019年6月，正大天晴药业控股公司南京正大天晴制药按仿制药3类提交的奥贝胆酸片上市申请获得受理，成为国内首家奥贝胆酸申报上市的药企，有望年内获批。（详见图5）       图5 奥贝胆酸片注册进展（源自药智网数据库）       06-卡格列净二甲双胍缓释片       卡格列净二甲双胍缓释片是一款口服复方降糖药，是由固定剂量卡格列净和缓释二甲双胍组成。这两种复方药在单一片剂中结合了两种机制互补的降糖药，可提供卡格列净及二甲双胍的临床属性。卡格列净是为日服一次的口服糖尿病药物，属于选择性钠葡萄糖共转运体2（SGLT2）抑制剂的一类新药，也是FDA批准的第一个SGLT2抑制剂。该类药物通过阻断肾 脏对血糖的重吸收以及增加尿液中血糖的排泄，来降低机体血糖水平。二甲双胍则是2型糖尿病早期治疗时的一线药物，可单独或与其他药物（包括胰岛素）联合用药。       卡格列净二甲双胍缓释片原研是强生，2016年9月FDA批准了强生的糖尿病复方新药卡格列净二甲双胍缓释片（Invokamet XR，卡格列净/缓释二甲双胍），结合饮食和运动，用于2型糖尿病成人患者的一线治疗。目前卡格列净二甲双胍缓释片原研在国内未获批上市。       乐普药业近几年在降糖药市场加紧布局，口服降糖药单方制剂已获批的产品有阿卡波糖片、磷酸西格列汀片，2021年11月乐普药业首家提交卡格列净二甲双胍缓释片的上市申请，目前该品种暂无其它药企申报，乐普药业有望拿下首仿。（详见图6）       图6 卡格列净二甲双胍缓释片注册进展（源自CDE数据库）       07-右兰索拉唑肠溶胶囊       右兰索拉唑属于质子泵抑制剂，为兰索拉唑的 R-异构体，通过抑制胃壁细胞酸生成部位的 H+-K+-ATP 酶的活性而抑制胃酸分泌。       右兰索拉唑肠溶胶囊原研是武田制药(Takeda Pharma.)北美公司， 2009 年1月首先在美国上市，随后在加拿大批准上市，用于治疗各种程度的糜烂性食管炎、非糜烂性反流性食管炎及相关症状的维持治疗。目前右兰索拉唑肠溶胶囊原研在国内未获批上市。       据公开数据显示，2016-2019年，武田制药的右兰索拉唑全球销售额均保持在600亿日元以上，2020年受新冠疫情影响，销售额下滑至556亿日元（约5亿美元）。       目前国内有正大天晴药业和江苏豪森药业布局此产品，正大天晴是首家报产。另外，改良型新药注射用右兰索拉唑最早由盛禾(中国)生物制药于2019年首家申报上市，2022年11月30日已获批上市。（详见图7）       图7 右兰索拉唑肠溶胶囊注册进展（源自CDE数据库）       08-磷丙替诺福韦片       磷丙替诺福韦，与替诺福韦酯同是新型核苷酸类逆转录酶抑制剂，是国外乙肝初始治疗首推药物替诺福韦二吡呋酯（TDF）的升级版，是目前公认的治疗乙肝的优选药物。磷丙替诺福韦是替诺福韦的前体修饰药，在肝细胞中，被分解成为有活性的代谢产物--二磷酸替诺福韦。在保持较高病毒抑制率的情况下，磷丙替诺福韦没有发现耐药性，较替诺福韦能更有效改善骨骼安全性系数，降低骨质疏松症风险，且对肾脏的危害更小。       磷丙替诺福韦片（TAF），又称富马酸替诺福韦艾拉酚胺片，由吉利德研发，用以治疗伴有代偿性肝病的慢性乙肝（HBV）感染患者的药物。原研产品于2016年11月10日在美国获批上市（商品名：Vemlidy），随后12月19日于日本上市，2017年1月9日获欧洲EMA批准，成为欧洲近10年来首 个获批上市的乙肝新药。2017年10月9日，吉利德在中国提交了磷丙替诺福韦片的上市申请，随后于2017年12月被纳入到CDE优先审评程序。截止目前，原研尚未在国内获批上市。       2018年10月22日，正大天晴以"化药新注册分类3类"提交了磷丙替诺福韦片的上市申请，这是本品首家国产仿制药的上市申请。正大天晴的肝病用药业务，在国内一直处于领先地位，主力产品有恩替卡韦分散片、异甘草酸镁注射液、甘草酸二铵肠溶胶囊、马来酸恩替卡韦片、阿德福韦酯胶囊等。另外还有申报该品种的还有江西青峰药业。这一场首仿争夺之战是仿制与原研进口之战，谁能率先进口上市，谁能争得首仿，对其市场布局都至关重要。（详见图8）       图8 磷丙替诺福韦片/富马酸替诺福韦艾拉酚胺片注册进展（源自CDE数据库）       09-司替戊醇干混悬剂       司替戊醇（Stiripentol），是一种新型抗癫痫药物，与氯 巴 占联用于治疗婴儿期严重肌阵挛性癫痫（Dravet 综合征）相关的癫痫发作。       司替戊醇原研是法国Biocodex公司，有胶囊和干混悬剂两种剂型， 2001 年司替戊醇因其可用于婴儿严重肌阵挛性癫痫（SMEI）而被欧盟认定为"孤儿药"。随后于 2007 年1月获得欧盟上市授权（商品名：Diacomit），可与氯 巴 占和丙戊酸盐联合使用，用于婴儿期严重肌阵挛性癫痫（SMEI，Dravet 综合征）的难治性全身性强直性阵挛性癫痫发作的辅助治疗；2018 年8月，司替戊醇获美国 FDA 批准与氯 巴 占联合治疗 2 岁及以上 Dravet 综合征相关癫痫发作患者。在国内，司替戊醇尚未获批上市。       2022年4月石家庄四药提交了司替戊醇干混悬剂的上市申请，是国内独家申报。司替戊醇干混悬剂是符合儿童生理特征的罕见病药物，主要用于治疗严重肌肉震颤性小儿癫痫，2022年5月司替戊醇干混悬剂上市申请以"符合儿童生理特征的儿童用药品新品种、剂型和规格"为由纳入了CDE的优先审评品种名单。（详见图9）       图9 司替戊醇干混悬剂注册进展（源自CDE数据库）       说明：本文不构成任何投资建议和价值判断。       参考资料：       1-NMPA官网数据库       2-丁香园Insight数据库       3-FDA官网数据库       4-药智网数据库       5-EMA官网数据库       6-米内网数据库       作者简介：zhulikou431，高级工程师、PDA会员、ISPE会员、ECA会员、PQRI会员、资深无菌GMP专家，在无菌工艺开发和验证、药品研发和注册、CTD文件撰写和审核、法规审计、国际认证、国际注册、质量体系建设与维护领域，以及无菌检验、环境监控等领域皆具有较深造诣。近几年开始着力关注制药宏观领域趋势分析和制药企业并购项目的风险管理工作。智药研习社3月直播讲座报名智药研习社3月线下研习会报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~