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    热门词:生物显微镜 水质分析仪 微波消解 荧光定量PCR 电化学工作站 生物安全柜

    现在位置时时彩网络平台>技术资料首页>行业动态>公司动态>安进与安斯泰来成立合资公司Amgen-Astellas BioPharma KK

    快速路最低限速多少: 安进与安斯泰来成立合资公司Amgen-Astellas BioPharma KK

    Amgen2013年5月31日 13:30 点击:1470

    时时彩网络平台 www.qlgr.net 美国安进公司(Amgen)   日本,安斯泰来,Astellas,


    2013年5月29日,全球最大的独立型生物技术公司——安进(Amgen)和日本制药公司安斯泰来(Astellas)联合宣布,双方已达成了战略联盟,开发新的药物以满足日本患者严重未满足的医疗需求。

    该联盟将通过新的商业模式充分利用双方的互补能力。该模式旨在将Amgen管线中的候选药物与Astellas对日本患者及医生需求的了解、在日本长期的商业经验和监管经验、及其作为领先制药公司在日本的强大存在结合起来。

    Amgen管理层曾在2月份投资者和分析师会议上宣布,计划在2015和2016年将其业务扩大至亚洲主要市场,同时宣称其在日本和中国市场缺乏存在,是一个很明显的缺口。

    该联盟的首个元素是双方之间的一项长期合作,该合作的重点是在日本共同开发及共同商业化Amgen管线中的5种候选药物,包括4种生物制剂和1种小分子药物,开发用于心血管、骨骼疾病、癌症的治疗,预计首个药物将于2016年在日本上市。

    联盟的第2个元素是,双方在日本东京成立一家合资公司,通过该合资公司,双方将携手合作,使Amgen迅速建立在日本的地面能力(on-the-ground capabilities)。合资公司的名称为Amgen-Astellas BioPharma KK,由Eiichi Takahashi担任总经理,其余管理职位将由Amgen和Astellas委任,该公司将于2013年10月1日开始运营,并随着长期合作的继续,最快于2020年成为Amgen全资子公司。

    该联盟将有助于加快Amgen管线药物在日本的开发及商业化,反映了Amgen致力于日本市场的长期使命,同时也是Amgen全球扩张战略的重要一步。

    此次联盟合作开发的5种管线药物分别为:

    *AMG 145:抗PCSK-9单克隆抗体,开发适应症:高脂血症(Hyperlipidemia),开发进程:全球(III期),日本(II期);
    *Romosozumab(AMG 785):抗硬化蛋白(Sclerostin)单克隆抗体,开发适应症:骨质疏松(Osteoporosis),开发进程:全球(III期),日本(II/III期);
    *Rilotumumab(AMG 102):抗HGF单克隆抗体,开发适应症:胃癌(Gastric Cancer),开发进程:全球(III期),日本(I期);
    *Blinatumomab(AMG 103):抗CD19 BiTE(抗CD19双特异性单链抗体),开发适应症:急性淋巴细胞白血?。ˋLL)和非霍奇金淋巴瘤(NHL),开发进程:全球(II期),日本(-)
    *AMG 337:MET抑制剂,开发适应症:胃癌(Gastric Cancer),开发进程:全球(I期),日本(-)。

     

    May. 29, 2013
    Amgen And Astellas Announce Japan Alliance
    Innovative Joint Venture to Address Unmet Medical Needs of Patients in Japan

    THOUSAND OAKS, Calif. and TOKYO, May 29, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN), the world's largest independent biotechnology company, and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503, "Astellas"), a leading Tokyo-based global pharmaceutical company, today announced the companies have entered into a strategic alliance to provide new medicines to help address serious unmet medical needs of Japanese patients.

    The alliance leverages the complementary capabilities of both companies through an innovative business model that combines Amgen's pipeline candidates with Astellas' deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading company in Japan.

    The first element of the alliance is a long-term collaboration between the two companies that will focus on the co-development and co-commercialization in Japan of five Amgen pipeline medicines. The five medicines, which include four biologics and one small molecule, are focused on the treatment of cardiovascular and bone diseases and cancer. The pipeline medicines range from early to late stages of development in Japan, with the first potential commercial launch expected as early as 2016.

    The second element of the alliance is the establishment of a Tokyo-based joint venture company through which the companies will work together to enable Amgen to rapidly build on-the-ground capabilities in Japan. The joint venture will operate under the name Amgen Astellas BioPharma KK and will be led by  Eiichi Takahashi, who will serve as general manager. Additional management roles will be appointed by Amgen and Astellas. The joint venture will be staffed by seconded employees from Astellas, transferred employees from Amgen and newly hired employees. It is expected that the joint venture will start operations on Oct. 1, 2013, and will become a wholly owned Amgen affiliate as soon as 2020 with the long-term collaboration continuing.

    "Through this alliance, Amgen will work closely with Astellas to leverage its extensive knowledge of the local market," said  Robert A. Bradway, chairman and chief executive officer atAmgen. "With Astellas' strong capabilities and excellent reputation, this alliance will help accelerate development and commercialization of Amgen medicines for patients in Japan. This alliance reflects our long-term commitment to the Japan market and is an important step in our global expansion efforts."  

    "We look forward to entering this alliance with Amgen and believe it will strengthen our pipeline to address unmet medical needs, as well as enable us to obtain growth drivers," said Yoshihiko Hatanaka, president and CEO of Astellas. "We will work closely with Amgen to build the joint venture, which will provide innovative medicines to patients in Japan."

    Goldman, Sachs & Co. is acting as financial advisor to Amgen in connection with this transaction. Morrison & Foerster LLP served as external legal counsel to Astellas.

    Five Amgen Pipeline Medicines Included in the Amgen Astellas Alliance

    Molecule

    Lead Indication

    Mode of Action

    Development Stage

    Global

    Japan

     

    AMG 145

     

    Hyperlipidemia  

    Anti-PCSK-9 mAb

    Phase 3

    Phase 2

     

    Romosozumab

    (AMG 785)1

     

    Osteoporosis

    Anti-Sclerostin mAb

    Phase 3

    Phase 2/3

     

    Rilotumumab

    (AMG 102)

     

    Gastric Cancer

    Anti-HGF mAb

    Phase 3

    Phase 1

     

    AMG 337

     

    Gastric Cancer

    MET inhibitor

    Phase 1


     

     

    Blinatumomab

    (AMG 103)

     

    Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin's Lymphoma (NHL)

    Anti-CD19 BiTE®

    Phase 2


     

    About Amgen

    Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    About Astellas

    Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in urology, immunology (including transplantation) and infectious diseases, oncology, neuroscience and DM complications and kidney diseases. For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.

    (来源: Amgen )


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