【好消息】施贵宝在美国和欧洲申请恩替卡为的NDA

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Bristol-Myers Squibb Applies in US and Europe for Marketing of Experimental Agent Entecavir for Chronic Hepatitis B


Bristol-Myers Squibb (BMS) announced on October 4, 2004 the submission of a New Drug Application (NDA) to the US Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic Hepatitis B.

In the European Union, BMS also submitted a marketing authorization application for entecavir to the European Medicines Evaluation Agency.

Entecavir is an investigational oral antiviral discovered at Bristol-Myers Squibb that is designed to selectively inhibit the hepatitis B virus, blocking all three steps in the replication process.

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Entecavir, New Hep B Drug, BMS Files NDA with FDA Press release issued by BMS today sent to you for your information. "BRISTOL-MYERS SQUIBB SUBMITS APPLICATIONS IN U.S. AND EUROPE TO MARKET ENTECAVIR, AN INVESTIGATIONAL ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B INFECTION" PRINCETON, NJ-- OCTOBER 4, 2004 -- Bristol-Myers Squibb Company (NYSE: BMY) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic Hepatitis B. In the European Union, the Company also submitted a marketing authorization application for entecavir to the European Medicines Evaluation Agency. Entecavir is an investigational oral antiviral discovered at Bristol-Myers Squibb that is designed to selectively inhibit the Hepatitis B virus, blocking all three steps in the replication process. Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Contacts: David M. Rosen Bristol-Myers Squibb Phone: 609-252-5675 Pager; 866-308-4484 [email protected] Patrice Grand Bristol-Myers Squibb Phone: +33 158836706 Mobile: +33 686427585 [email protected]

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治慢性乙肝新药有望上市欧美市场

日前,百时美施贵宝公司分别向美国食品药品监督管理局递交了恩替卡韦的新药申请,与此同时,该公司也向欧洲药品评估局递交了恩替卡韦在欧盟的上市许可申请。据了解,恩替卡韦是百时美施贵宝公司正在研发的一种用于治疗慢性乙肝的抗病毒新药。此药是一种口服药物,能高效抑制乙型肝炎病毒(HBV)的复制。恩替卡韦于1996年进入人体试验,目前全球三期临床试验已经结束。百时美施贵宝公司将于10月底在波士顿召开的美国肝病年会上公布三期临床结果。据有关人士透露,试验显示,恩替卡韦对初次患者和对拉米夫定失效或耐药患者都有一定的疗效。

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有人要做恩替卡为！

企业名称浙江车头制药有限公司

行　业生物医药

通讯地址 浙江仙居县大战

邮　编 317321

网　　址 www.chariotpharm.com

[email protected]

联系电话0576-7641903

传　真 0576-7641987

联 系 人 蒲通

技术难题名称抗病毒新药恩替卡韦的技术合作开发主要内容和技术经济指标

1、质量达到进口产品标准 2、产品易工业化、成本低 3、合成工艺技术简短，不涉及知识产权保护拟提供资金面议 备　注 未填关 键 字抗病毒新药；恩替卡韦

起始时间2003-12-31截至时间2004-12-31反馈 　

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[此贴子已经被作者于2004-10-26 20:35:21编辑过]

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The Liver Meeting 55th Annual Meeting of the American Association for the Study of Liver Diseases October 29 - November 2 Boston, Massachusetts John B. Hynes Convention Center

Over 5,000 hepatologists and hepatology health professionals from around the world will meet to exchange the latest liver disease research, discuss treatment outcomes and interact with colleagues.