Agila Specialties, Inc.

DUBLIN, June 23, 2023 /PRNewswire/ -- The Global Biosimilars Partnering Terms and Agreements 2010 to 2023 report has been added to ResearchAndMarkets.com's offering. The Global Biosimilars Partnering Terms and Agreements 2010 to 2023 report provides an understanding and access to the biosimilars partnering deals and agreements entered into by the world's leading healthcare companies. Trends in biosimilars dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 200 biosimilars deal records and contract documents where available The leading biosimilar deals by value since 2010 Most active biosimilars dealmakers since 2010 The leading biosimilars partnering resources The Global Biosimilars Partnering Terms and Agreements report provides an understanding and access to the biosimilars partnering deals and agreements entered into by the world's leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter biosimilars partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors biosimilars technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual biosimilars deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. For example, analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? The initial chapters of this report provide an orientation of biosimilars dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in biosimilars dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading biosimilars deals since 2010. Deals are listed by headline value, signed by big pharma, most active biosimilars dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in biosimilars dealmaking with a brief summary followed by a comprehensive listing of biosimilars deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010. The chapter is organized by specific biosimilars technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by biosimilars partnering company A-Z, deal type definitions and biosimilars partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in biosimilars partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of biosimilars technologies and products. Companies Mentioned 3SBio 180 Life Sciences Abbvie Abreos Biosciences Abzena Accord Healthcare Aceno Biotherapeutics AdAlta AET Biotech Aetos Biologics AffaMed Therapeutics Agila Specialties AIT Bioscience Algorithme Pharma Holdings Alteogen Altiora Alvogen Alvotech Amedica Amgen Amneal Pharmaceuticals Arecor Avid Bioservices Axantia Back-A-Line Bacterin International Baxalta Baxter International BeiGene Bio-Manguinhos/Fiocruz Bio-Thera Solutions Biocnd Biocon Bioeq IP Bio Farma Biogen and many, many more! For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Global Biosimilars Partnering Terms and Agreements 2010 to 2022" report has been added to ResearchAndMarkets.com's offering. The Global Biosimilars Partnering Terms and Agreements 2010 to 2022 report provides an understanding and access to 190 biosimilars partnering deals and agreements entered into by the worlds leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter biosimilars partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors biosimilars technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual biosimilars deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of biosimilars dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in biosimilars dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading biosimilars deals since 2010. Deals are listed by headline value, signed by big pharma, most active biosimilars dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in biosimilars dealmaking with a brief summary followed by a comprehensive listing of biosimilars deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010. The chapter is organized by specific biosimilars technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by biosimilars partnering company A-Z, deal type definitions and biosimilars partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Global Biosimilars Partnering Terms and Agreements 2010 to 2022 includes: Trends in biosimilars dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 190 biosimilars deal records and contract documents where available The leading biosimilar deals by value since 2010 Most active biosimilars dealmakers since 2010 The leading biosimilars partnering resources In Global Biosimilars Partnering Terms and Agreements 2010 to 2022, the available contracts are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy and technology target Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in biosimilars dealmaking 2.1. Introduction 2.2. Biosimilars partnering over the years 2.3. Most active biosimilars dealmakers 2.4. Biosimilars partnering by deal type 2.5. Biosimilars partnering by therapy area 2.6. Deal terms for biosimilars partnering 2.6.1 Biosimilars partnering headline values 2.6.2 Biosimilars deal upfront payments 2.6.3 Biosimilars deal milestone payments 2.6.4 Biosimilars royalty rates Chapter 3 - Leading biosimilars deals 3.1. Introduction 3.2. Top biosimilars deals by value Chapter 4 - Most active biosimilars dealmakers 4.1. Introduction 4.2. Most active biosimilars dealmakers 4.3. Most active biosimilars partnering company profiles Chapter 5 - Biosimilars contracts dealmaking directory 5.1. Introduction 5.2. Biosimilars contracts dealmaking directory Chapter 6 - Biosimilars dealmaking by technology type Appendices Appendix 1 - Biosimilars deals by company A-Z Appendix 2 - Biosimilars deals by stage of development Appendix 3 - Biosimilars deals by deal type Appendix 4 - Biosimilars deals by therapy area Appendix 5 - Appendix 6 - Recent report titles from Companies Mentioned 3SBio 180 Life Sciences Abbvie Abreos Biosciences Abzena Accord Healthcare Aceno Biotherapeutics AdAlta AET Biotech Aetos Biologics AffaMed Therapeutics Agila Specialties AIT Bioscience Algorithme Pharma Holdings Alteogen Altiora Alvogen Alvotech Amedica Amgen Amneal Pharmaceuticals Arecor Avid Bioservices Axantia Back-A-Line Bacterin International Baxalta Baxter International BeiGene Bio-Manguinhos/Fiocruz Bio-Thera Solutions Biocnd Biocon Bioeq IP Bio Farma Biogen Biooutsource BiosanaPharma BioSavita BioSciencesCorp Bioton BioXpress Boehringer Ingelheim Bolt Biotherapeutics Boston Oncology Bruker C-Bridge Capital Catalent CEA-Leti Celares Celerion Cellectis Celltrion Changchun High & New Technology Industries Chemo Sa Lugano Chungnam National University Cipla CJ Corp Clinigen Cobra Biologics Coherus Biosciences Compass Biotechnologies Concord Biosciences Cook Pharmica CR Pharma Daiichi Sankyo Diabeloop DM Corporation Dong-A ST Dr. Reddy's Laboratories Dyadic International EirGenix EMD Millipore Enzene Biosciences Epirus Biopharmaceuticals Epivax European Commission Evercyte Evotec Ewopharma Formosa Pharmaceuticals Formycon Fujifilm Fujifilm Kyowa Kirin Biologics Fuji Pharma GC Pharma Gedeon Richter GE Healthcare Genentech Genhelix Biopharmaceutical Genor Biopharma GenScript ProBio Gerresheimer Hadasit Medical Research Services and Development Hanwha Chemical Helvetic Biopharma Henlius Biotech Hikma Pharmaceuticals Hoffmann La Roche Horizon 2020 Hospira Innovent Biologics Intas Pharmaceuticals inVentiv Health Ipca Laboratories Ipsen Jacobson Pharma JAMP Pharma Group JHL Biotech Kamada Karolinska Institute Kemwell BioPharma Kymos Pharma Services Kyowa Hakko Kirin Laboratorios Liomont LABORATORIOS SAVAL Ligacept Livzon Mabpharm Lupin M+W Group Mab-Venture Biopharma Mabion mAbXience Medicago Medicure Medipolis Meiji Seika Merck and Co Merck BioVentures Merck KGaA Merck Serono MGC Diagnostics Ministry of Health (Brazil) Mithra Pharmaceuticals Mitsubishi Chemical Mochida Pharmaceutical Momenta Pharmaceuticals Mundipharma Mylan Laboratories Mylan Pharmaceuticals Nan Fung Group NanoLock Natco Pharmaceuticals National Cancer Institute National Comprehensive Cancer Network (NCCN) NCPC GeneTech Neoletix Biotechnology NeuClone Nora Pharma Novo Nordisk Ocumension Therapeutics Oncobiologics ORF Genetics Orox Pharmaceuticals Orygen Biotecnologia Pall Corporation Pangen Biotech Parexel PBS Biotech Perfinity Biosciences Pfenex Pfizer Pharmapark PharmaPraxis PlantForm PlantPraxis Biotecnologia Polpharma Portal Instruments PPD PRA Health Sciences Premier Inc Premier Research Prestige BioPharma ProBioGen PT Etana Biotechnologies Qilu Pharmaceutical Quanta BioDesign QuiaPEG Pharmaceuticals For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Mylan pharma（迈兰制药）的历史可追溯到上世纪60年代。1961年，年仅27岁的传奇人物Milan Puskar和Don Panoz一道，组建了这家公司。起初的迈兰制药并不销售药品，只是一家弗吉尼亚的药品分销商，直到60年代中后期，迈兰制药才开始生产维生素、青霉素和四环素。70年代初期，迈兰制药又获批生产红霉素、氨苄西林等抗生素，业务得到了不错的发展，最终在1973年挂牌上市。六七十年代的美国，仿制药受到反替代法的限制，市场占有率并不高，开发仿制药的公司也同样少之又少。尽管此时FDA几乎已经完成了再评价任务，但仿制药的审批监管路径还在探索阶段，准入门槛非常高，因此仿制药也属于相对稀缺的资源，而在此期间拥有多个仿制药（品牌仿制药）的迈兰制药自然也得到很快的发展，到80年代中期，迈兰制药已经成为“全美最大的独立药品生产商（The Nation's Largest Independent Drug Manufacturer）”，其年报数据显示，该公司在1987年的销售额已超过1亿美元。虽然Waxman-Hatch法案的实施为美国仿制药发展带来了宝贵的黄金时期，但早期的迈兰制药一直在努力发展品牌药。1984年，迈兰制药的第一个品牌药 Maxzide（氢氯噻嗪/氨苯蝶啶）获得FDA批准，为了摆脱仿制药企业的形象，迈兰的战略重点是打造迈兰实验室（Mylan lab），让迈兰制药整合为Mylan lab的全资子公司。1989年，迈兰实验室收购了Somerset pharma 50%的股权，以获得帕金森药物Eldepryl（司来吉兰）的销售权。1993年，又收购了透皮制剂的研发和生产商Bertek，试图利用该公司的技术进行制剂改良。由于美国大力推行仿制药替代，八九十年代是美国仿制药行业爆炸式增长的时代，行业利润非常可观，毛利可达50%-60%，而且很低的研发、销售、管理投入就能维持业务快速增长，营业利润可达40%-50%，并不比品牌药逊色。虽然该公司在打造品牌药上花费了不少努力，但仿制药才是更现实、发展更快的道路，而且在“重点发展品牌药”的过程中，该公司已经积攒了近百个仿制药品种的批文。从迈兰年报中不难看出，销售额从1987-1993年仅增长了1.4亿美元，其原有的发展战略不得不再二次审视。1996年，迈兰收购了仿制药生产企业UDL Lab，并与其子公司迈兰制药合并整合为仿制药部门，1997财年（1996年）报告显示该部门销售额达3.82亿美元，占公司销售额的87%。在战略重心转移之后，迈兰的仿制药业务得到飞速发展，透皮载药技术平台Bertek也开始开发生产透皮仿制药，仿制药销售额开始高速增长，并在1998年（1999财年）首次超过6亿美元，被称为当时全球第二大仿制药企业。对于仿制药企业而言，增加销售额的常见路径除了努力开发ANDA批文和兼并仿制药企业，就是提高竞争不充分产品的价格。然而该公司因为过度涨价（劳拉西泮涨了3倍）遭到联邦贸易委员会（FTC）调查，最终不得不支付1.5亿美元用于解决纷争。因为这场纷争，迈兰元气大伤，三年（1998-2000）的仿制药销售规模没有明显地增长。2001年初，迈兰抢到丁环螺酮的首仿，获得180天市场独占期，该产品在市场独占期内为公司带来1.68亿美元的净销售额，而且其它新ANDA也为该公司带来近7000万美元的销售额增长，于是仿制药总销售额达到了9.71亿美元，离10亿美元仅一步之遥。2002年，迈兰换帅，创始人卸任，原战略咨询顾问Robert J. Coury被任命为CEO、副董事长（2009年成为董事长并一直至今），同年，该公司仿制药销售额首次突破了10亿美元。然而首仿药的市场独占期是短暂的，很快迈兰的仿制药增长又出现了乏力，2001-2005年间，销售额几乎无增长。这样的财务数据对一个公司新领导而言，一点也不体面，于是迈兰不得不策划新的发展战略。2004年，迈兰试图40亿美元收购King pharma，但未获成功，2007年初，迈兰7.36亿美元吞并了印度仿制药企Matrix Lab，大幅增加了原料和新兴市场的制剂供应能力，与此同时，Matrix销售额写进公司的年报，总销售额增加至16.1亿美元（仿制药15.3亿美元）。然而，酝酿要40亿美元吃掉King pharma的Coury，不是区区一个Matrix就能填饱肚子，于是在2007年秋天，再次以66亿美元的价格吃掉了默克雪兰诺的仿制药部门，同时还获得了Epipen（肾上腺素预充针）的销售权。Epipen是美国家庭和学校等公共场所的储备用药，销售额一直从接盘时的2亿美元一直做到20多亿美元，成为一大摇钱树。经过两期大规模兼并，迈兰的仿制药销售额出现了暴涨，在2008年达到42.87亿美元，再次成为仅次于梯瓦、山德士的全球第三大仿制药企。经过业务大整合，迈兰仿制药业务的活力被焕发出来，2008-2014年间，该公司仿制药销售额稳步增长，销售额从42.87亿美元增加至64.59亿美元，总销售额则随之从51.38亿美元增加至77.20亿美元，市值在2015年二季度创下记录，达360亿美元。迈兰/辉致的股价变化2007年之后的六七年间，迈兰并没有开展大规模的仿制药业务并购，但在此期间，仿制药企业的并购非常流行，华生、梯瓦和山德士都在开展大规模兼并，于是该公司再次亮出并购之剑，在2013年吞并了印度仿制药企业Agila。在收购Agila之后，该公司的并购步伐再难停下，2015年又分别以53亿美元和7.5亿美元收购了雅培非美国市场的专科药、品牌仿制药业务和印度Famy Care公司，在加速布局新兴市场布局的同时，使仿制药销售额首次达到81.58亿美元。然而迈兰并未就此知足，该公司还试图以260亿美元的代价接管百利高。在收购百利高失败不久，该公司又把目光转向欧洲制药公司Meda和Renaissance的仿制药与专科药业务，最终在2016年分别以99亿美元和10亿美元的价格成交。2010-2015年间，是仿制药行业风起云涌的年代，不是兼并其它企业就是被其它企业所兼并。在迈兰报价百利高失败之后，很快就成为了梯瓦的兼并目标。2015年4月，梯瓦对迈兰开出401亿美元的高价，迈兰的股价也因梯瓦的收购要约而提高至历史最高值，达360亿美元。或许迈兰并不希望被兼并，梯瓦的401亿美元出价仍被视为敌意收购，交易最终告吹，梯瓦不得不把目光转向艾尔建的仿制药部门阿特维斯。而交易失败后的迈兰，股价开始下滑，为了增强投资人的信心，该公司在2016年又吞并了Meda和Renaissance……经过2013-2016年的兼并，迈兰成为真正意义上的国际巨头，北美以外地域的影响力得以大幅加强，北美地区销售额占比从2012年的58%下降至51%，新兴市场的销售额占比从14%提高至22%。于是迈兰又对原有的业务再次进行重组，形成以地域为特色的业务部门。2016年财报数据显示，迈兰新整合的三个地域部门销售额分别为57.63亿美元（北美）、30.73亿美元（欧洲）和国际28.02亿美元。重组业务架构后，迈兰的品牌药业务在2018年达到52.23亿美元，而仿制药业务则因为产品调整而销售额大幅缩水，2018年仅剩57.5亿美元。迈兰/辉致的财务现状2016年之后，美国仿制药市场因价格下滑而逐渐萎缩，虽然迈兰成功拿下舒利迭和格拉替雷的首仿，但仍止不住利润逐年下滑。一方面是行业的走衰，另一方面是公司的运营战略不被投资人看好，迈兰的股票在2015年问鼎后一路走低。然而，在利润和股价下行之时，迈兰并没有压缩规模以保证现金流，反而仍以8.9亿美元的代价，收购了Aspen的澳大利亚仿制药业务和欧洲血栓治疗产品包，使得2019年净利润仅为1700万美元，2020年更是出现了净亏损，市值更是在2020三季度下降至82.6亿美元，完全已经没有一个国际仿制药巨头的范。2021年，迈兰与普强合并成为辉致，虽然表观上让公司的销售额规模从2020年的118.2亿美元提高至178.1亿美元，品牌药销售额更是从2020年的52.3亿美元增加到108.4亿美元，且成功打入了中国市场，但在这次合并中辉瑞股东拿走了57%的股权，迈兰股东仅剩下43%，而且合并后销售额的增加几乎来自已经失去专利保护的品牌药（Established products），未来增长潜力很小，不仅如此，因为这次合并，总债务（total liability）从193.7亿美元增加至386.0亿美元——这让人们在辉致上看到了梯瓦的影子，加之2020和2021年的持续净亏损，新公司的市值又只剩下126亿美元，似乎这次合并是个赔本的买卖，当初401亿美元出售给梯瓦反而可能是更好的选择。—END—联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作数据库咨询 | 琳琳 18983288589（微信同号）会议合作 | 赖老师 13550291524（微信同号）园区合作 | 周老师 18725665133（微信同号）定制服务 | 陈老师 18908392210（微信同号）媒体合作 | 小薇  18908208341（微信同号）点击阅读原文，体验药融云专业服务！