翰宇药业此前在2018年6月14日公告：
AMWGmbH位于德国巴伐利亚州瓦恩高市，成立于2008年，致力于开发、生产和销售先进的给药制剂产品如透皮给药缓释贴片和皮下生物可降解缓释植入剂等高端缓控释制剂产品，在生殖系统肿瘤、神经性疾病、皮肤病、糖尿病和疼痛治疗等快速增长的适应症领域提供更优治疗方案。已上市产品有戈舍瑞林植入剂、亮丙瑞林植入剂、丁丙诺啡透皮贴剂、卡巴拉汀透皮贴剂和夜间修复疤痕贴等重磅产品，以及大量待申报上市品种。AMW先进的透皮给药缓释贴片和皮下生物可降解缓释植入剂等高端缓控释技术大大提高了患者的用药便利性，降低了患者用药痛苦，在全球药物制剂应用前景十分广泛。中国境内迄今尚未有可达到欧盟等发达国家质量要求的同类生产技术，国际上拥有该类技术的公司也是屈指可数。
Since its foundation in 2008, AMW has developed an attractive and advanced product pipeline: 4 products are currently filed for approval (launch expected in 2013/14) and 4 further products are in progressed clinical development. AMW`s manufacturing site in Warngau, Germany, is GMP approved, including approval in accordance of the controlled substances act.
Prior to the foundation of AMW GmbH, Dr. Fischer had founded his first company, Novosis AG in 1997. After a successful sale of the company to the Swiss Schweizerhall Group, the company now operates under the name of Acino AG.（此处可以回顾绿叶收购其透皮释药物业务单元）
The core area of both companies was, from the start, development and production of new and technologically demanding drug delivery systems. Thus Dr. Fischer could grow the Acino AG to one of the largest contract manufacturers of generic transdermal systems in Europe.
AMW GmbH had developed beyond that. The business model of AMW is built on two pillars: proprietary products and development and supply contracts with pharmaceutical and MedTech companies.
Proprietary products: AMW carries out clinical development through the approval process at its own or at shared costs and thus owns or at least co-owns IP and marketing rights. The approved products are licensed out to a marketing partner. We provide our development partners comprehensive services, from initial ideas to the approval and registration of complex products and their production, as well as selected individual services. Excellence in research and development, transparence and reliability in project work as well as precision in manufacturing are our key to success in all partnerships.
The current most important products include diverse highly active implants and transdermal patches, such as for the treatment of certain hormone responding tumors, chronic pain or neurologic and psychiatric diseases. In addition, we have developed new patented technologies for the active control of drug releasing pharmaceuticals as well as innovative approaches for transdermal delivery.
Data and Facts
AMW GmbH’s growth at a glance starting with the newest item
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2018
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Change of ownership at AMW: pharma specialist for drug delivery systems enters new growth stage
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2017
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Investment Plan for Europe: EIB grants financing to pharmaceutical company AMW
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2015
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Mit Datum vom 28.August 2015 hat das BfArM Zulassungen aus DCP-Verfahren für Rivastigmin Pflaster in den Dosierungen 4,6 mg/24 h und 9,5 mg/24 h für die Länder Deutschland, Österreich, Rumänien, Schweden, Slowakei und die Tschechische Republik erteilt
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AMW GmbH announces the closing of another financing round with the current shareholders –
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AMW GmbH entered in January 2014 into a semi-exclusive license and supply agreement for its biodegradable implant goserelin formulation with a major multinational pharma company. –
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2013
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Certification according to ISO EN 13485: 2012/AC: 2012 by Tüv Süd -> more
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2012/2013
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closing of third round financing lead by SHS Gesellschaft für Beteiligungsmanagement mbH
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production of first market batches of an innovative topical patch
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successful completion of the pivotal clinical studies and submission of an EU registration file for an Alzheimer patch
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successful completion of a feasibity study with an active-control opioid patch
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successful conclusion of a pilot study with an opioid patch
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successful conclusion of a pilot study with an Alzheimer patch
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successful conclusion of a pilot study with a cancer patch
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submission of third registration file
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conclusion of third clinical study
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2011
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closing of second round financing lead by SHS Gesellschaft für Beteiligungsmanagement mbH
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closing of a development contract with an international pharma company for a pain patch with active drug release
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closing of a cooperation contract with an international pharma company for development and manufacturing of a locally active patch
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conduction of a clinical study with an innovative cancer patch
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closing of a cooperation contract for development and international sales of two transdermal systems
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manufacturing license for commercial supplies with sterile products and transdermal systems -> more
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conduction of a futher clinical pase III study for a cancer product
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submission of first registration files
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conclusion of first clinical studies
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2010
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installation of a manufacturing unit for transdermal systems
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2009
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begin of a clinical phase III study for two cancer products
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manufacturing license for sterile drug products -> more
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2008
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Closing of first round financing lead by SHS Gesellschaft für Beteiligungsmanagement mbH, Tübingen and involvement of KfW, Frankfurt/Main, and Bayern Kapital GmbH, Landshut
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July 2008
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Foundation by Dr. Wilfried Fischer in Warngau with own capital
PRESS RELEASE
Change of ownership at AMW
pharma specialist for drug delivery systems enters new growth stage Warngau, 04 July 2018. The owners of AMW GmbH are entering into an agreement to sell their shares in the specialty pharma company located in Warngau along with its subsidiary Endomedica GmbH located in Halle (Saale) to a consortium led by Hybio Pharmaceutical and YF capital. The new owners intend to support the further growth of AMW, invest in the development of new products, and advance the company’s internationalization efforts. The sellers include AMW founders, healthcare investor SHS Gesellschaft für Beteiligungsmanagement, funds managed by Bayern Kapital, KfW, IBG Risikokapitalfonds II, BayBG Bayerische Beteiligungsgesellschaft and UVC Partners. Located in Warngau, Bavaria, AMW was established in 2008 with a focus on the development, production and sale of advanced pharmaceutical formulations such as transdermal drug delivery systems and subcutaneous biodegradable sustained-release implants. Transdermal and parenteral drug delivery systems offer better treatment options in a rapidly growing field of indications in oncology, neurology, dermatology, diabetes and pain treatment. Sold products include Goserelin and Leuprorelin implants as well as Buprenorphine and Rivastigmin patches. AMW has a strong pipeline of newly developed products addressing potential billion-dollar markets.
Hybio (300199.SZ) is a leading biopharmaceutical company that focuses on research, development, manufacturing and commercialization of peptides and peptide-based drugs.
YF Capital is a private equity firm started by a group of successful entrepreneurs and influential industry leaders. With the 100% acquisition of AMW, the new owners are following an international expansion strategy—adding products and a R&D pipeline to the portfolio. Synergies include the use of a global sales force, especially in the key markets of the USA and China, as well as the start of new development projects to address unmet needs. The transaction is still pending formal approval of the regulatory authorities. “Both Hybio and YF Capital intend to maintain and accelerate the growth of the company’s current structure including the transdermal and parenteral products, business sites in Warngau and Halle (Saale), as well as the skilled employees and management team” says Dr. Albert Huang, Vice President from YF Capital, “with the capacity of a financially strong strategic partners, we do believe that AMW can proceed to the next level in the pharma business, also we strongly believe the collaboration between AMW and Hybio will be highly beneficial for both parties, addressing global market growth opportunities.”
Dr. Wilfried Fischer, managing director of AMW, adds “the commitment of the new owner to the existing product pipeline as well as the willingness to make use of the technology to start new development projects perfectly matches AMW’s long-term strategy.” Dr. Bernhard Schirmers, founder and managing partner of SHS, comments “together with our co-investors we have backed the company for a long time and are very proud of AMW’s development. This acquisition by a strategic investor underscores the company’s excellent positioning. With the new owner, AMW can enter into the next growth stage.” About AMW GmbH AMW GmbH is an innovative and fast-growing specialty pharmaceuticals company headquartered in Warngau near Munich, Germany. AMW develops, produces and sells drug delivery systems with a focus on biodegradable implants and transdermal treatment systems. The company was founded in 2008 and develops solutions for use in oncology, neurology, dermatology and pain management applications.
About Hybio Pharmaceutical: Incorporated in China, it’s a leading bio-pharmaceutical company that focuses on the research, development, production and commercialization of therapeutic peptides and peptide-based drugs. Hybio has been listed on the Shenzhen Stock Exchange (300199.SZ) since 2011. Hybio’s main products are focused on the therapeutic areas of digestive diseases, cardio-cerebrovascular diseases, diabetes, infectious diseases, and reproductive system diseases. Hybio has 13 GMP certificates from the CFDA and has invested over $100 million to establish a new finished dosage facility based in Pingshan of Shenzhen City, which includes a production line of solution injection, lyophilization powder and cartridge. Furthermore, Hybio has also built two Active Pharmaceutical Ingredient (API) lines that have passed both the US FDA and EU inspections. A new API production base of larger scale, oral sustained release tablet / capsule and biosimilar product manufacturing line are being established in Wuhan of Hubei Province. Hybio has been active in the global pharmaceutical market for over 10 years. Hybio has filed its first ANDA (Eptifibatide for Injection) on June 19, 2014 and is in the process of developing other complex generic ANDAs.Hybio has also been the peptide API supplier for many top pharmaceutical clients globally. Hybio has launched two generic peptide APIs in 8 European countries, and plans to have additional ANDAs filed and approved in the U.S. in the next few years. About YF Capital YF Capital established in early 2010 and named after its co-founder Mr. Jack MA (Yun), executive chairman of Alibaba Group (BABA.N), and Mr. David YU (Feng), founder of Target Media. YF Capital’s focus sectors include internet, technology, healthcare, media & entertainment, financial services, logistic and consumer. YF Capital is a private equity firm started by a group of successful entrepreneurs and influential industry leaders. The mission and vision is not only to provide capital, but also to share with the portfolio companies the experience and lessons learned, helping them to better formulate corporate strategy, optimize organizational structure and establish brand recognition.
About SHS Gesellschaft für Beteiligungsmanagement mbH SHS Gesellschaft für Beteiligungsmanagement is based in Tübingen, Germany and invests in medical technology and life science companies with a focus on expansion financing, changes in shareholder structures and successor situations. SHS holds minority as well as majority interests. The company was founded in 1993 and has since gained extensive experience as an industry investor, which supports the growth of its portfolio companies through a network of partnerships regarding the introduction of new products, regulatory issues or entering new markets. The SHS fund’s German and international investors include the European Investment Fund, professional pension insurers, retirement funds, funds of funds, family offices, entrepreneurs and the SHS management team. The AIFM-registered company is currently investing from its fourth generation of funds, for which investors have provided 125 million euro. Equity capital of up to 20 million euro is invested. Transactions can be carried out in the mid double-digit million range together with a network of coinvestors. Reinhilde Spatscheck, Dr. Bernhard Schirmers, Hubertus Leonhardt and Uwe Steinbacher are the Managing Partners at SHS.
About Bayern Kapital Bayern Kapital GmbH, based in Landshut, was founded on the initiative of the Bavarian government in 1995. It is a wholly-owned subsidiary of the Bavarian LfA Förderbank. As the venture capital organization of the Land of Bavaria, Bayern Kapital provides equity capital financing for the founders of young innovative technology companies in Bavaria. Presently Bayern Kapital manages eleven investment funds with a total volume of around €340 million. So far, it has invested almost €260 million in more than 250 innovative companies in the fields of technology in various sectors including life science, software & IT, medical technology, materials and new materials, nanotechnology and environmental technology. This has helped create over 5,000 long-term jobs in sustainable companies in Bavaria.
About KfW KfW is one of the world’s leading promotional banks. With its decades of experience, KfW is committed to improving economic, social and ecological living conditions across the globe on behalf of the Federal Republic of Germany and the federal states. To do this, it provided funds totaling €76.5 billion in 2017 alone; and of this, 43% went into measures for protecting the environment and combating climate change. KfW does not have any branches and does not hold customer deposits. It refinances its promotional business almost entirely through the international capital markets. In 2017 KfW raised some €78 billion for this purpose. In Germany, the KfW Group is represented in Frankfurt, Berlin, Bonn and Cologne. Its network includes 80 offices and representations around the world.
About the IBG funds The IBG funds, based in Magdeburg, are the risk capital funds of the German state of Saxony Anhalt. The IBG funds provide investment capital up to €5 million for innovative technology SMEs with longterm and above-average growth potential that are headquartered in or have a branch office in Saxony-Anhalt. The IBG funds are managed by bmp Ventures AG, Berlin and Magdeburg. www.ibgvc.de
About BayBG Through its investments, BayBG is currently strengthening the capital base of 500 Start-ups and medium-sized businesses. The BayBG is thus the one of the market leaders among medium-sized enterprise-oriented investment companies. Through its commitment, the BayBG enables the companies and start-ups to realize expansion and innovation plans, make corporate succession plans as well as optimize their capital structures.
About Unternehmertum Venture Capital Partners Unternehmertum Venture Capital Partners (UVC Partners) is a Munich-based early-stage venture capital firm that invests in technology-based startups in Germany, Austria, and Switzerland. UVC Partners focuses on investments in the areas of industrial technologies, smart enterprises and mobility. The fund typically invests between €0.5-3 million initially and up to €12 million in total per company. Portfolio companies benefit from the extensive investment and exit experience of the management team as well as from the close cooperation with UnternehmerTUM, Europe’s leading innovation and business creation center. With over 180 employees and more than 100 industry partners, UnternehmerTUM can draw from many years of experience in establishing young companies. This cooperation enables UVC Partners to offer startups unique access to talent, industry customers and other financial partners. Website: www.uvcpartners.com
其他相关信息：
LinkedIn: https://www.linkedin.com/company/unternehmertum-fonds-management-gmbh/ Xing:
https://www.xing.com/companies/unternehmertumventurecapitalpartners
https://www.bioportfolio.com/news/article/3379369/AMW-GmbH-Pharmaceuticals-Healthcare-Deals-and-Alliances-Profile-Report-Updated-12102017-Prices.html；
http://listofcompanies.co.in/2011/12/13/acino-holding-ag/;
关于AMW GmbH
德国AMW GmbH制药公司成立于2008年，主要从事新型给药系统药物剂型的研发、研发及销售。拥有两大系列产品及技术，分别是透皮贴剂产品及技术和缓释植入剂产品及技术，公司创始人Dr. Fisher是该领域全球著名科学家。未来在研产品包括微控释贴剂、单抗控释技术平台等。
Novosis AG-Schweizerhall -ACINO HOLDING AG;
AMW GmbH,Dr. Fisher.
始发于微信公众号： 药物简讯