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百健艾迪与Amunix合作开发凝血因子VIII新产品

来源:生物谷 2014-04-22 14:21

2014年4月21日讯 /生物谷BIOON/ --生物技术公司Amunix 4月21日宣布,合作伙伴百健艾迪(Biogen Idec)已行使其选择权,目前双方已达成一项全球性独家许可协议,研究和开发具有改善的治疗特性的新颖、完全重组凝血因子VIII产品。

根据协议条款,Amunix将获得100万美元预付款,同时将有资格获得3900万美元的临床和商业化里程碑款项。此外,Amunix还将获得利用该公司专有XTEN技术所合作开发的凝血因子VIII产品在未来销售的特许权使用费。

早在2011年3月,百健艾迪和Amunix启动了一项研究和选择协议,根据该协议,双方将共同合作,把Amunix在延长蛋白半衰期方面的XTEN专有技术与百健艾迪在血友病和工程化长效凝血因子方面的专业知识结合起来,开发新的凝血因子产品。

根据今天宣布的许可协议,百健艾迪行使了其选择权,将负责开发、生产和商业化来自该项合作中的候选治疗产品。

关于Amunix公司

Amunix是一家生物技术公司,总部位于美国加州,该公司已开发了一种基于XTEN的新颖半衰期延长技术。XTEN蛋白是一种亲水性、非结构化的多肽,比含有相同氨基酸数目的任何其他球状蛋白质体积大得多。XTEN可与其他多肽、蛋白和小分子重组融合或化学偶联,大大增加其有效体积,从而通过类似于聚乙二醇(PEG)的方式减缓肾脏清除率,延长药物在血清中的存在。除减缓肾脏清除率外,XTEN还能通过降低配体对受体的亲和力,抑制受体介导的清除作用,而这种效果是其他半衰期延长技术如人血清白蛋白(HSA)和Fc所不能达到的。因此,XTEN可通过多种机制来影响药物的血药浓度,从而极大地延长药物半衰期,有望使多种药物的给药频率降低至每月一次。

通过这种专有的XTEN技术,该公司已创造和开发了数个新颖的临床验证的治疗产品,可提供更好的疗效、安全性,并能通过延长药物半衰期改善给药频率。目前,2种XTEN产品:艾塞那肽(Exenatide)-XTEN(VRS-859)和人生长激素(hGH)-XTEN(VRS-317)已完成I期临床研究。

除百健艾迪外,Amunix也与强生(JNJ)旗下杨森(Janssen)达成合作,将XTEN技术应用于杨森所选择的蛋白或多肽药物。(生物谷Bioon.com)

英文原文:BIOGEN IDEC SIGNS LICENSE AGREEMENT WITH AMUNIX FOR XTENYLATED FACTOR VIII

– Amunix could receive up to $39 million in upfront and milestone payments –

Mountain View, CA – April 21, 2014 – Amunix Operating Inc. announced today that Biogen Idec (NASDAQ: BIIB) has exercised its option to enter into an exclusive, worldwide license agreement to research and develop novel, fully-recombinant Factor VIII products with improved therapeutic properties.  Under the terms of the option agreement, Amunix will receive an upfront $1 million payment and will also be eligible to receive up to $38 million in clinical and commercial milestone payments.  In addition, royalties will be paid on commercial sales by Biogen Idec for Factor VIII products incorporating Amunix proprietary XTEN technology.

In March 2011, Amunix and Biogen Idec initiated a Research and Option Agreement under which both companies would collaborate to combine Amunix’s expertise in protein half-life extension and its proprietary XTEN technology with Biogen Idec’s expertise in both hemophilia and engineering long-lasting coagulation factors.  Under the license agreement announced today, Biogen Idec triggered its option for XTENylated Factor VIII products. Biogen Idec will be responsible for developing, manufacturing and commercializing therapeutic product candidates resulting from the collaboration.  

“We are pleased to be working with Biogen Idec as our partner, and their decision to exercise this option validates the utility of our XTEN technology,” said Volker Schellenberger, PhD, Amunix President and Chief Executive Officer.  “The initial research collaboration resulted in the discovery of molecules that are clearly differentiated from current Factor VIII products in that they retain procoagulant activity while having unprecedented half-life in animal models,” Dr. Schellenberger added.  “Collaborations such as ours with Biogen Idec are a central element of the Amunix strategy to facilitate the use of XTEN in a wide range of therapeutic applications.”

About Amunix

Amunix Operating Inc., a biotechnology company headquartered in Mountain View, CA, has developed a novel half-life extension technology based on XTEN; hydrophilic, unstructured polypeptides which can be recombinantly fused or chemically conjugated to other peptides, proteins and small molecules.  Through this proprietary XTEN technology, the company creates and develops novel versions of clinically-proven pharmaceutical products that may offer better efficacy, safety and dosing frequency by extension of the half-life.  Two XTEN products, Exenatide-XTEN (VRS-859) and hGH-XTEN (VRS-317), have completed Phase 1 studies through Amunix partners Diartis and Versartis, respectively.  Versartis is currently conducting a Phase 2a study with VRS-317 in pediatric growth hormone deficient patients.  In addition to its partnership with Biogen Idec, Amunix is working with Janssen Biotech, Inc. and its affiliates to apply the XTEN half-life extension technology with protein and/or peptide therapeutics selected by Janssen.  Amunix has several other undisclosed partners in various therapeutic areas.   Founded in 2006, Amunix is a profitable, independent biotechnology company with no external investors.  Amunix is actively seeking partnerships for application of its XTEN technology.

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