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强生授权穷国生产仿制抗艾药物生产
2011/2/22/11:24来源：医药经济报
【慧聪制药工业网】强生公司日前达成一笔交易，准备在获得监管部门批准之前将一只实验性艾滋病药物授权给别的药厂生产。此举在业内引发一场争论：专利药厂应采取何种合作模式加快艾滋病药进入贫穷国家。
百分之一的支付费用
强生表示，它旗下部门Tibotec制药公司同意让3家仿制药公司在非洲撒哈拉以南地区、印度以及部分亚洲国家提供仿制TMC278的产品。纽约艾滋病疫苗倡导联盟（AVAC）执行主任米歇尔·华伦表示，如果将以往提供给贫穷国家的艾滋病药作为参考，强生此举有望令TMC278在发展中国家的销售价格下降到美国病人所需支付费用的百分之一。
联合国艾滋病规划署在去年11月的一份报告中指出，2009年，艾滋病夺去了全球大约180万人的生命，HIV已成为全球最致命的传染病。华伦表示，强生的决定或促使其它制药公司效仿，寻求达成类似协议。
“这一决定具有重大意义，确实能加快这类产品以较低价进入发展中国家市场。
例如，由加州Gilead科技公司生产的艾滋病药Truvada在美国的售价为每粒35~40美元，在非洲的仿制产品也许只需要40美分。
Tibotec公司计划把TMC278分别授权给Mylan印度分公司、位于印度海得拉巴的HeteroDrugs公司以及位于南非约翰内斯堡的AspenPharmacare公司。
华盛顿非营利组织“知识生态国际”（KEI）致力于扩大药品在发展中国家的使用范围，该组织表示，强生是第一家在药品获得监管部门批准之前授权其它药厂生产仿制艾滋病药物的生产商。
不过，这项协议并非尽善尽美。近年来，外界一直呼吁制药公司将药品专利授权给“药物专利池”（MPP，MedicinesPatentPool）——这是联合国旨在鼓励药厂对低成本药品开展研究的一项努力。强生的此次协议却无视这一呼吁。
“药物专利池”项目发言人卡利·马拉表示，Tibotec公司的举措无疑带来帮助，但该公司应进一步扩大药品的使用范围。去年，强生曾提出请求，同意将专利授权给MPP。目前，MPP正等待强生对这项请求所给出的回应。
授权印度和南非
强生将TMC278授权给联合国指定的48个“最不发达国家”以及印度和南非使用。这份名单不包括北非、拉丁美洲（海地除外），以及包括巴基斯坦、菲律宾和印度尼西亚在内的亚洲国家。
Tibotec公司发言人表示，这项协议是TMC278市场覆盖战略的第一部分，“我们在监管部门批准TMC278之前就采取了这种积极的态度。这项协议既包括那些HIV发病率最高的国家，也包括经济负担最重的国家”。
目前，Tibotec公司正等待寻求美国和欧洲监管部门批准TMC278，该公司表示并不清楚销售TMC278的仿制品会节省多少费用。仿制药厂必须花费一定时间对该药的配方进行研究，“我们将把技术和信息转让给它们，要让TMC278尽快进入这些国家市场。”该发言人称。
根据强生的声明，仿制药公司将向Tibotec公司支付销售TMC278仿制产品收入的2%~5%作为特许权使用费。Tibotec公司预计在这种安排上不会超过收支平衡线。
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| 图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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Johnson authorized the poor production of generic Kangai Yao materials production
2011/2/22/11: 24 Source: Medicine Economic News
【Network】 HC Johnson & Johnson pharmaceutical industry has reached a deal in preparation for regulatory approval prior to an experimental AIDS drug licensed to other pharmaceutical production. This triggered a debate in the industry: pharmaceutical patent cooperation model should be taken to accelerate access to AIDS drugs in poor countries.
To pay one per cent
Johnson said it Tibotec Pharmaceuticals, a division agreed to three generic drug companies in sub-Saharan Africa, India and some Asian countries imitation TMC278 products. New York, AIDS Vaccine Advocacy Coalition (AVAC) Executive Director Mitchell Warren said that if the previously provided to AIDS drugs in poor countries as a reference, a move that could make TMC278 Johnson sales prices in the developing countries to the United States needed patient one percent of pay.
UNAIDS in a report last November that in 2009, AIDS killed about 180 million lives worldwide, HIV has become the world's most deadly infectious diseases. Warren said that Johnson's decision or make other pharmaceutical companies follow suit and seek to conclude a similar agreement.
"This decision is of great significance, such products can really accelerate a more low-cost access to markets in developing countries.
For example, by the California technology company Gilead's AIDS drug Truvada in the United States sells for 35 to 40 dollars each and, in Africa, generic products may only need 40 cents.
TMC278 Tibotec plans to branch offices were authorized to Mylan in India, located in Hyderabad, India, and is located in Johannesburg, South Africa HeteroDrugs company's AspenPharmacare company.
Washington non-profit organization "Knowledge Ecology International" (KEI) is committed to expanding the use of medicines in developing countries, the organization said, Johnson is the first regulatory approval of drugs before licensing the production of other pharmaceutical manufacturers of generic AIDS drugs .
However, this agreement is not perfect. In recent years, the public has called on pharmaceutical companies to pharmaceutical patents to "drugs patent pool" (MPP, MedicinesPatentPool) - This is the United Nations to encourage pharmaceutical companies to conduct research on a low-cost drugs efforts. Johnson & Johnson's current deal has ignored this call.
"Drug patent pool," said project spokesman for the Cali horses, Tibotec is no doubt the company's initiatives to bring help, but the company should further expand the use of drugs. Last year, Johnson had requested, agreed to license the patent to the MPP. Currently, MPP Johnson is waiting on a response given to this request.
Authorized to India and South Africa
TMC278 licensed to Johnson & Johnson will be the 48 United Nations-designated "least developed countries" as well as India and South Africa to use. This list does not include North Africa, Latin America (except Haiti), and including Pakistan, the Philippines and Indonesia and other Asian countries.
Tibotec company spokesman said the agreement is TMC278 market coverage strategy, the first part, "We TMC278 in the regulatory approval before taking such a positive attitude. The agreement includes both those countries with the highest incidence of HIV, including The most important national economic burden. "
At present, Tibotec company is awaiting U.S. and European regulatory authorities seeking approval of TMC278, the company said sales of TMC278 was not clear imitation of how much will be saved. Must spend some time imitation pharmaceutical formulations for the drug study, "we will transfer technology and information to them, let TMC278 as soon as possible to enter the market in these countries." The spokesman said.
According to Johnson's statement, generic drug companies will pay the sales of TMC278 Tibotec generic products, the company earnings of 2% to 5% of royalties. Tibotec company expects to break even this arrangement does not exceed line.
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