2008年1月9日
汤姆森公司 (The Thomson Corporation)旗下子公司、面向全球研究和企业界的信息解决方案领先提供商汤姆森科技信息集团 (Thomson Scientific) 发布了第一期《Movers and Shakers》。Pharma Matters（制药事务）丛书中的这一最新报告对2007年7月至9月之间的美国仿制药市场进行了分析，简要介绍了一些闯入该市场的企业，并重点介绍了目前正面临挑战的分子专利。
《Movers and Shakers》利用引用自汤姆森科技信息集团 Newport Horizon Global 的战略情报和竞争分析信息评述了美国仿制药市场，以便对全球最重要的制药市场之一进行评估。Newport Horizon Global 是来自全球仿制药行业权威的关键产品锁定以及全球业务开发系统。
汤姆森科技信息集团仿制药与原料药情报 (Generics and API Intelligence) 部门主管 Kate Kuhrt 表示：“由于美国仿制药市场的动态性质，有一种共识认为进入这个市场相对会容易一些。但我们的研究显示在资质老的和希望分得市场一杯羹的新兴企业之间存在着激烈的竞争，并且很明显将有赢有输。我们的报告是首类旨在发现仿制药市场真正的‘挑战者’的季度报告。”
第一期季度报告涵盖了2007年7月至9月这一阶段，凸显了反映该行业发展情况的关键指标。
《Movers and Shakers》下载网址（同时上传一份到本地）：
免费订阅：
m-a-s-jul-sep07.pdf (191.37k)
Wednesday January 9, 12:00 am ET
Report Draws On Strategic Intelligence and Competitive Analysis Information From Newport Horizon Global(TM)
PHILADELPHIA and LONDON, Jan. 9 /PRNewswire-FirstCall/ -- Thomson Scientific, part of The Thomson Corporation (NYSE: TOC - News; TSX: TOC - News) and leading provider of information solutions to the worldwide research and business communities, has released the first issue of Movers and Shakers. This newest report in the Pharma Matters series analyzes the U.S. generics market from July to September 2007, profiles some of the companies breaking into the market, and highlights molecule patents currently being challenged.
Movers and Shakers reviews the U.S. generics market using strategic intelligence and competitive analysis information drawn from Thomson Scientific's Newport Horizon Global, the critical product targeting and global business development system from the industry authority on the global generics market, in order to assess one of the world's most important pharmaceutical markets.
"Because of the dynamic nature of the generics market in the U.S., the common perception is that the market is relatively easy to break into," said Kate Kuhrt, director, Generics and API Intelligence, Thomson Scientific. "However, our research has shown that there is huge competition between the incumbents and new companies vying for a slice of the market, and clearly there will be winners and losers. Ours is the first quarterly report to identify the real 'movers and shakers' within the generics market."
The first quarterly report covers the period of July to September 2007, and highlights the key indicators of the state of play of the industry. These are:
Abbreviated New Drug Applications (ANDA): An ANDA is the first step in the process a company needs to follow in order to release a generic drug in the U.S. and is submitted to the FDA to prove that the generic version is equivalent to the brand name drug (reference listed drug).
Paragraph IV challenges: A generic company may obtain FDA approval before patent expiry if it certifies its product does not infringe the listed patents or the patents are invalid (paragraph IV certification). In addition, the first company to file an ANDA with paragraph IV certification is awarded a 180-day period of exclusivity for the ensuing generic product, giving the filer an important competitive advantage. Bioequivalent generic versions of drugs that are not protected by patents can be produced and marketed in the U.S. by any company, subject to FDA approval.
Who Are the Movers and Shakers This Quarter?
Molecules recently exposed to paragraph IV challenges: Big Pharma companies such as sanofi-aventis, Eli Lilly, Hoffmann-La Roche and AstraZeneca all saw challenges in the period from July to September on molecules they have patented.
Companies taking their first steps into the US generics industry: The report highlights companies that were felt to be of significant interest. This quarter, the report focuses on Dabur India Ltd, who launched a Paragraph IV challenge on the drug oxaliplatin, Zhejiang Huahai Pharmaceutical Group Co Ltd, a Chinese company that has received tentative approval for nevirapine 200mg tablets under the President's Emergency Plan for Aids Relief (PEPAR) program, and GeneraMedix Pharmaceuticals Inc., an American company based in New Jersey that has received FDA approval for a selection of new products.
"The global stakes involved in the US generics market become evident when you see that the top country filing ANDAs in the US is India, and the company recorded as having the most Paragraph IV patent challenges is Teva, an Israeli Pharma company," added Kuhrt. "Clearly, the message is that American companies cannot presume that they will have a home advantage in this market."
About This Quarterly Report:
Data for this report was compiled and analyzed using Newport Horizon Global® a critical product targeting and global business development system from Thomson Scientific. Created specifically for generic pharmaceutical companies and strategic API manufacturers, it allows them to identify and evaluate product opportunities worldwide, ensuring they will be the first to find the generic product and niche opportunity, first to make the deal, and first to get to market.
For people who are engaging the generic and API products business to pay a lot of attention!!!
费城、美国，伦敦、英国，2008年1月9日——汤姆森公司(The Thomson Corporation)(NYSE:TOC;TSX:TOC)旗下子公司、全球科技信息服务行业的领导者汤姆森科技信息集团（Thomson Scientific，简称汤姆森科技）发布了第一期《仿制药发展动态》季度报告。《汤姆森药业新观察》丛书中的这一最新报告对2007年7月至9月之间的美国仿制药市场进行了分析，简要介绍了一些进入该市场的企业，并重点介绍了目前正面临专利挑战的分子。
《仿制药发展动态》利用引自汤姆森科技信息集团 Newport Horizon Global 的战略情报和竞争分析信息评述了美国仿制药市场，以便对全球最重要的一个制药市场进行评估。Newport Horizon GlobalTM收集来自全球仿制药市场的可靠信息，为制造企业在寻找评估新产品项目，以及制定企业发展战略的过程中提供权威的分析数据，帮助企业更快更好地做出决策。
汤姆森科技信息集团仿制药与原料药情报 (Generics and API Intelligence) 部门主管 Kate Kuhrt 表示：“由于美国仿制药市场的动态性质，有一种共识认为进入这个市场相对会容易一些。但我们的研究显示在资深企业的和希望占据市场一席之地的新兴企业之间存在着激烈的竞争，并且很明显将有赢有输。我们的报告是首类旨在发现仿制药市场真正的‘挑战者’的季度报告。”
第一期季度报告，着重指出从2007年7月至9月之间，以能体现仿制药行业发展状况的关键指标来阐述行业发展动态。这两个指标是：
简略新药申请 (Abbreviated New Drug Applications，ANDA)：简化新药申请是仿制药进入美国市场的第一步，该申请需提交给美国食品及药物管理局 (FDA)，以证明该仿制药与被仿制的原创药生物活性相当。
Paragraph IV专利挑战：如果一个仿制药企业能证明其产品没有侵犯现有专利或相关专利无效，那么它就可以获得 FDA 的许可。此外，第一家提交带有Paragraph IV专利挑战的 ANDA申请的企业，为其产品保留180天的市场独占权。在这180天内其他企业则不能申请生产该仿制产品，从而赋予了该申请者一个重要的竞争优势。在美国，只要能获得 FDA 的批准，任何公司都可以生产不受专利保护的具有生物等效性的仿制药。
最近面临 Paragraph IV 专利挑战的分子药物：从2007年7月至9月，赛诺菲－安万特 (sanofi-aventis)、礼来公司 (Eli Lilly)、罗氏 (Hoffmann-La Roche) 以及阿斯利康 (AstraZeneca) 等大型制药企业均在他们拥有专利的分子药物方面遇到了挑战。
开始迈出进军美国仿制药行业的第一步的企业：该报告重点介绍了那些被认为有强烈意愿要进军美国仿制药行业的公司。该季度，这份报告主要聚焦了 Dabur India Ltd（该公司针对奥沙利铂 (Oxaliplatin) 药提出了 Paragraph IV专利挑战）、浙江华海药业集团有限公司（根据美国总统艾滋病救援紧急计划，这家中国公司的奈维拉平 (Nevirapine) 200mg 药片已经获得了暂时批准）以及总部位于新泽西的美国公司 GeneraMedix Pharmaceuticals Inc.（该公司精选的一批新产品已经获得了 FDA 的批准）。
Kuhrt 接着说：“你会发现在美国提交最多 ANDA 申请的国家是印度。而提出最多 Paragraph IV 专利挑战的是以色列制药企业 Teva，这表明全球资本对美国仿制药市场的参与已经变得很明显了。显然，这暗示了这样一个信息——美国企业再不能认为它们在该市场拥有主场优势了。”
这份报告所用的数据来源于Newport Horizon Global。该产品专为仿制药生产企业以及战略性原料药 (API) 生产商设计，使他们能够发现并评估全球范围内的产品机遇，确保他们最先发现仿制药产品和把握市场机遇，并最先达成交易和实现上市。
《Movers and Shakers》中文版《仿制药发展动态》下载：
突然看见多了个《汤姆森药业观察》，感觉似曾相识，于是进来看看。
我记得以前参加一些新药研讨会的时候，汤姆森科技信息集团都会派人前往宣传的。因此对这个公司多少有一点了解。
汤姆森的数据库给我的感觉是，信息很全面、很专业、很庞大。
虽然一年几十万，我觉得如果用得好的话，还是比较值的。
不过我们现在没有公司支持，没办法享受这种服务了。
建了个《汤姆森药业观察》，把一些非赢利性的信息在园子里披露，可以开拓我们的眼界，我认为这是好事！支持！
这个栏目是企业冠名赞助吧？如果真是企业赞助，能否多拿出些实惠信息给我们分享呢，否则会砸了信誉的，呵呵。
有最新的资料没有？