强生与Vertex合作开发A型流感新药

强生与Vertex合作开发A型流感新药来源：生物谷 2014-06-19 09:19

                               
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2014年6月19讯 /生物谷BIOON/ --强生（JNJ）6月18日宣布，与Vertex制药签署独家许可协议，获得新型流感药物VX-787的全球开发、制造及商业化权利。VX-787是一种新颖的流感治疗药物，目前正处于II期临床开发，用于A型流感的治疗。
VX-787是一种实验性药物，在体外实验中，能够直接抑制A型流感病毒的复制，包括近年的H1（流感大流行）和H5（禽流感）流感毒株。流感是一种急性病毒感染，很容易通过呼吸道飞沫传播，或通过污染的手或表面传播。流感病毒对现有抗病毒药物产生抗性已非常普遍，通过VX-787的开发，强生希望为患者提供一种新的治疗选择。
该许可协议，还将授予强生开发、生产和商业化VX-787的备份化合物VX-353的权利，以及开发、生产和商业化特定其他备份化合物用于预防和/或治疗流感的权利。
Vertex公司于2013年完成了VX-787的IIA期研究。双方预计将在未来几个月内开展更多的临床试验。
关于VX-787：
VX-787是一种首创、A型流感特异性、口服聚合酶抑制剂，该药是首个也是临床上走的最远的一种具新颖作用模式（mode of action，MOA）的直接作用抗流感病毒药物，该药通过靶向流感病毒PB2聚合酶亚基发挥作用，该药有望成功治疗对现有其他MOA抗病毒药物产生耐药的流感病毒株。
迄今为止，VX-787已表现出对Vertex所选择的所有A型流感病毒株具有强劲、快速的体外抗病毒作用，包括对达菲（Tamiflu，通用名：osetamivir，奥司他韦）产生耐药性的A型流感毒株。初步的临床评估显示VX-787非常有前景。I期研究证明VX-787具有良好的耐受性，同时也提供了药代动力学特性，支持每日一次的给药方案。已完成的IIa期研究表明，VX-787在A型流感病毒感染的病毒学和临床评测方面表现出了统计学意义的显著改善，证明了临床概念验证。（生物谷Bioon.com）
英文原文：Janssen Announces License Agreement With Vertex To Develop Novel Treatment For Influenza A
TITUSVILLE, NJ, July 18, 2014 – Janssen Pharmaceuticals, Inc. (Janssen) announced today that it has entered into an exclusive license agreement with Vertex Pharmaceuticals for the worldwide development, manufacturing and commercialization of VX-787, a novel medicine in Phase II development for the treatment of influenza A.
VX-787 is an investigational medicine designed to directly inhibit replication of the influenza A virus, including recent H1 (pandemic) and H5 (avian) influenza strains, based on in-vitro data. Influenza is an acute viral infection that spreads easily through respiratory droplets produced when an infected person coughs or sneezes, or through contaminated hands and surfaces.[1] Universally, resistance has emerged to existing antivirals for influenza and, through the development of VX-787, Janssen hopes to provide an additional treatment option for patients.
“Influenza infection remains one of the most serious public health challenges globally. In addition to the burden of seasonal influenza, the pandemics of the 20th and 21st centuries exemplify the threat the influenza A virus presents,” says Johan Van Hoof, Global TA Head Infectious Diseases and Vaccines, Managing Director, Crucell.  “This agreement builds on Janssen’s legacy of innovation and partnership, and we are proud to collaborate with Vertex on this novel medicine. This treatment has the potential to address a significant unmet medical need and to improve the well-being of patients everywhere.”
The license agreement also grants Janssen rights to develop, manufacture and commercialize VX-787’s back-up compound, VX-353, as well as rights to develop, manufacture and commercialize certain other back-up compounds for the prevention and/or treatment of influenza. The agreement is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Vertex completed a Phase IIA study of VX-787 in 2013. The parties expect additional clinical trials to begin in the coming months.
About VX-787
VX-787 is a first-in-class, influenza A-specific, oral polymerase inhibitor. It is the first and most advanced example of a novel mode of action (MOA) direct acting antiviral working through the influenza virus PB2 polymerase subunit. Targeting an alternative part of the viral replication process may help ensure that this new medicine can successfully treat strains of the influenza virus which may be resistant to existing antiviral drugs with other MOAs.
VX-787 has demonstrated potent and rapid in-vitro antiviral activity on all Vertex tested influenza A strains to date, including oseltamivir (Tamiflu®) resistant strains.[2]  Initial clinical assessments of VX-787 have also been promising. Phase I studies demonstrated the molecule was well tolerated in healthy volunteers providing a pharmacokinetic profile supportive of once daily dosing.2  Vertex has also completed a Phase IIA challenge study that showed statistically significant improvements in viral and clinical measurements of influenza A infection and demonstrated clinical proof of concept.[3]
About Influenza
Influenza occurs globally, with an average of 5–10 percent of adults and 20–30 percent of children becoming infected with the virus each year. Worldwide, annual influenza epidemics are estimated to result in about 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths.[4] Yearly influenza epidemics can seriously affect all populations, but the highest risk of complications occur among children younger than age 2 years, adults aged 65 years or older, pregnant women, and people of any age with certain medical conditions, such as chronic heart, lung, kidney, liver, blood or metabolic diseases (such as diabetes), or weakened immune systems.[4]
The treatment of influenza consists of antiviral medications that have been shown in clinical studies to shorten the disease and reduce the severity of symptoms if taken within two days of infection, however, there is a significant need for new medicines targeting flu that provide a wider treatment window, greater efficacy and faster onset of action.

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