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Dicerna™宣布完成与罗氏公司的全球合作和许可协议,以治疗 [复制链接]

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发表于 2019-12-20 20:22 |只看该作者 |倒序浏览 |打印

Dicerna™ Announces Closing of Worldwide Collaboration and Licensing Agreement With Roche for Treatments for Chronic Hepatitis B Virus Infection
December 19, 2019 07:30 AM Eastern Standard Time

LEXINGTON, Mass.--(BUSINESS WIRE)--Dicerna™ Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced the successful closing of the research collaboration and licensing agreement between Dicerna and Roche following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

As previously announced on Oct. 31, 2019, the companies entered into an agreement to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXC™ RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development, and includes the discovery and development of therapies targeting multiple additional human and viral genes associated with HBV infection using the technology platforms of both companies.

Dicerna will receive an upfront payment of $200 million, which is due early in the first quarter of 2020. Under the terms of the agreement, Dicerna may be eligible to receive up to an additional $1.47 billion over time for the achievement of specified development, regulatory and commercial milestones for DCR-HBVS. In addition, Dicerna may be eligible to receive royalties on potential product sales of DCR-HBVS. Dicerna also retains an option to co-fund the development of DCR-HBVS worldwide and, if exercised, would receive enhanced royalties on net sales in the United States. If Dicerna exercises this co-funding option, it shall also have an option to co-promote products including DCR-HBVS in the United States.

Dicerna and Roche also agreed to collaborate on the research and development of additional therapies targeting multiple human and viral genes implicated in chronic HBV infection, using technology from both companies, for which Dicerna is eligible to receive additional milestones and royalties on any potential products.

About Dicerna's GalXC™ RNAi Technology Platform

Dicerna’s proprietary ribonucleic acid interference (RNAi) technology platform, called GalXC™, aims to advance the development of next-generation RNAi-based therapies designed to silence disease-driving genes in the liver and other tissues. Liver-targeted GalXC-based compounds enable subcutaneous delivery of RNAi therapies that are designed to bind specifically to receptors on liver cells, leading to internalization and access to the RNAi machinery within the cells. The GalXC approach seeks to optimize the activity of the RNAi pathway so that it operates in the most specific and potent fashion. Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including both liver and non-liver indications.

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发表于 2019-12-20 20:22 |只看该作者
Dicerna™宣布完成与罗氏公司的全球合作和许可协议,以治疗慢性乙型肝炎病毒感染
十二月19,2019 07:30东部标准时间

马萨诸塞州列克星敦-(美国商业资讯)-研究性核糖核酸干扰(RNAi)治疗药物的领先开发商Dicerna™Pharmaceuticals,Inc.(纳斯达克股票代码:DRNA)(“公司”或“ Dicerna”)今天宣布:根据修订的1976年《哈特-斯科特-罗迪诺反托拉斯改进法》,等待期届满后,Dicerna与罗氏公司之间成功完成了研究合作和许可协议。

正如先前在2019年10月31日宣布的那样,两家公司已达成协议,将使用Dicerna专有的GalXC™RNAi平台技术开发用于治疗慢性乙型肝炎病毒(HBV)感染的新疗法。此次合作将专注于Dicerna在1期临床开发中的研究性治疗DCR-HBVS的全球开发和商业化,并将包括利用两家公司的技术平台发现和开发针对多种与HBV感染相关的其他人类和病毒基因的疗法。

Dicerna将获得2亿美元的前期付款,该笔款项将于2020年第一季度初到期。根据该协议的条款,Dicerna可能有资格随着时间的流逝获得多达14.7亿美元的额外款项,以实现特定的开发,监管和DCR-HBVS的商业里程碑。此外,Dicerna可能有资格就DCR-HBVS的潜在产品销售收取特许权使用费。 Dicerna还保留了为全球DCR-HBVS的发展共同出资的选择,如果行使,Dicerna在美国的净销售额将获得提高的特许权使用费。如果Dicerna行使此共同出资选择,则它也可以选择在美国共同推广包括DCR-HBVS在内的产品。

Dicerna和罗氏公司还同意使用两家公司的技术合作研究和开发针对多种与慢性HBV感染有关的人类和病毒基因的其他疗法,Dicerna有资格获得任何潜在产品的额外里程碑和特许权使用费。

关于Dicerna的GalXC™RNAi技术平台

Dicerna的专有核糖核酸干扰(RNAi)技术平台称为GalXC™,旨在推进下一代基于RNAi的疗法的开发,该疗法旨在使肝脏和其他组织中的疾病驱动基因沉默。以肝脏为靶标的基于GalXC的化合物可实现皮下递送RNAi疗法,这种疗法被设计成与肝细胞上的受体特异性结合,导致内化并进入细胞内的RNAi机制。 GalXC方法旨在优化RNAi途径的活性,使其以最特异性和最有效的方式运行。通过GalXC生产的化合物旨在广泛应用于多个治疗领域,包括肝脏和非肝脏适应症。

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发表于 2019-12-20 22:57 |只看该作者
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