想Sovaldi（sofosbuvir）?

StephenW

Want Sovaldi (sofosbuvir), the hepatitis C drug selling in the United States for $1,000 per pill, for just $10 a pill? Go to Bangladesh or some other country where the drug is about to be produced and sold free of the control of Sovaldi's owner, Gilead Sciences ($GILD). You can also head to Kathmandu and get a licensed copy at a rate that is also a fraction of the U.S. cost.

Less than a week after signing a nonexclusive licensing agreement with Gilead Sciences to manufacture and sell generic versions of its chronic hepatitis C medicines, India's Natco Pharma has Gilead products for sale in Nepal. According to local press reports, Natco launched generic copies of Sovaldi in Nepal last week, the first Indian drugmaker to use the license in this fashion and a move that is likely to set a benchmark on pricing. Natco did not immediately respond to a request for comment.

The licensing deal includes sofosbuvir, ledipasvir/sofosbuvir and the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase III clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all 6 genotypes of hepatitis C.

"This agreement allows Natco to expand access to these chronic hepatitis C medicines in 91 developing countries," Natco said in a March 2 release.

"Under the license, Natco can set its own price for the generic products it produces, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities."

Natco had last year tried to block Gilead's patent in India and the firm is one of the most aggressive in the use of compulsory licenses, including winning one for Bayer's Nexavar in India.

However, it seems Gilead never obtained a patent for its drug in Bangladesh, so local drugmaker Incepta Pharmaceuticals made its own generic of the drug and launched it last month. Managing Director Abdul Muktadir said his company is also to market the drug at a similar low price elsewhere in Southeast Asia and in Africa in countries where Gilead does not have a Sovaldi patent.

After taking a lot of fire for charging $84,000 per 12-week regimen of the drug, Gilead licensed the drug in 91 mostly poor countries. But Malaysia and Thailand were not among the 91 and their people are stuck paying higher prices.

In addition to Incepta's plan for non-patent countries, the World Health Organization has been discussing with the company the possibility of putting its generic in its prequalification program, a certification that opens it to bulk purchases by poor nations receiving WHO funds.

Gilead refers to Incepta's generic as one of the "unauthorized generic versions" of Sovaldi but suggested it could not or would not do anything about it when it added it was focused next door on its India and its licensees getting their versions to market as soon as possible. Gilead had not responded to a query on the status by publication. Incepta also did not respond to an email seeking comment on its plans.

- here's the Natco release
- and Bloomberg's story

StephenW

想Sovaldi（sofosbuvir），在美国丙型肝炎药物销售为1000美元丸，仅售10美元丸？进入孟加拉国或其他一些国家，药物即将生产和销售免费Sovaldi的所有者，吉利德科学公司（GILD $）的控制。您也可以前往加德满都，并获得许可副本的速度，这也是美国的一小部分费用。

不到一个星期签约Gilead Sciences公司非独占许可协议，生产和销售的慢性丙型肝炎药物的仿制药后，印度Natco公司制药公司Gilead公司产品销售在尼泊尔。据当地媒体报道，Natco公司上周推出Sovaldi的仿制尼泊尔，印度第一制药商使用许可在这个时尚的举动很可能设置在定价基准。 Natco公司没有立即回应记者的置评请求。

该许可协议包括sofosbuvir，ledipasvir / sofosbuvir和研究性NS5A抑制剂GS-5816，这是在第一阶段正在评估III期临床研究作为一个单一的平板电脑方案，结合了所有6个基因型丙型肝炎的治疗化合物和sofosbuvir的一部分。

“这项协议允许Natco公司以扩大获得这些慢性丙型肝炎的药物中91发展中国家，”Natco公司在3月2日发布的消息说。

“根据许可，Natco公司可以设定自己的价格，它生产的仿制产品，要在销售吉利德使用费，以支持产品注册，医学教育和培训，安全监控等重要的商业活动。”

Natco公司曾在去年试图阻止吉利德公司的专利在印度和企业是最积极的，在使用强制许可，其中包括赢得一个用于拜耳多吉美在印度之一。

然而，似乎从来没有吉利德获得的专利其在孟加拉国的药物，所以当地的制药商Incepta制药做出了自己的仿制药和上个月推出的。董事总经理阿卜杜勒Muktadir说，他的公司也向市场推出了药物在相似的低价其他地区在东南亚和非洲的国家里基列没有Sovaldi专利。

在考虑了很多火充电84000美元每药物12周疗程，吉利德许可的药物大多是91贫穷国家。不过，马来西亚和泰国都没有91之间和两国人民都陷入支付更高的价格。

除了Incepta的计划非专利国家，世界卫生组织一直在讨论与该公司把其通用在其资格预审程序的可能性，打开它，以批量采购通过接受WHO的资金贫穷国家认证。

Gilead公司是指Incepta的通用作为Sovaldi的“未经授权的仿制药”之一，但建议它不能或不愿当它增加它的重点是隔壁在其印度及其授权让他们的版本尽快上市做任何事情可能的。 Gilead公司没有回应查询由发布状态。 Incepta也没有回应寻求其计划发表评论的电子邮件。

- 这里的Natco公司发布
- 和彭博的故事

StephenW

(Bloomberg) -- A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesn’t have patents.

Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.

The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gilead’s license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isn’t patented could benefit from the new source of cheap copies.

Incepta’s price of about $900 for 12 weeks is the same price at which Gilead will offer its branded version of the drug in India. Even so, the Bangladeshi version shows the challenge facing Gilead from companies it doesn’t have agreements with in countries where the drug isn’t patented.

The World Health Organization said it is in talks with Incepta for its prequalification programme, which assesses drug quality. International aid agencies and countries look to this WHO certification as a reference when picking drugs for bulk purchases.

Gilead is “aware of unauthorized generic versions of sofosbuvir being offered in the marketplace,” the company said in an e-mail. “We’re focused on enabling our eleven Indian generic partners to launch their authorized generic versions as soon as possible.”
Marketplace

Under a World Trade Organization agreement, Bangladesh, as one of the world’s least developed countries, doesn’t have to protect pharmaceutical patents.

In the U.S., Sovaldi has sparked a backlash from commercial health insurers because of its cost of $84,000 for a 12-week course of treatment. In the rest of the world, the price of the drug is already set to plunge as Gilead’s licensees start selling.

Hyderabad-based Natco Pharma Ltd., one of Gilead’s licensees, launched its generic sofosbuvir in Nepal this month. Natco in a statement Monday said it had priced its generic medicine at 19,900 rupees ($318) for a bottle of 28 tablets in Nepal.

A number of other Sovaldi generics besides Incepta’s, also not authorized by Gilead, are in the works in Egypt, according to the Egyptian Initiative for Personal Rights.

The WHO is in talks with Incepta along with a “handful” of companies in India and Egypt on pre-qualification of Sovaldi generics, said Peter Beyer, senior advisor in WHO’s department of essential medicines and health products in Geneva.

Dhaka-based Incepta is currently preparing quality and dissolution studies on its version of sofosbuvir to submit in support of its international applications, Muktadir said.

“We are just a little ahead of them,” said Muktadir of his Indian competitors. “So, maybe we should be able to launch these products wherever it is required. In some countries in Africa, and some of the Southeast Asian countries where the burden is very high -- these are the countries we are looking at.”

Incepta’s sofosbuvir is approved for sale by the Bangladeshi drug regulator, said Mohammad Salahuddin, assistant director at the Directorate General of Drug Administration.
Generic Competitors

Gilead’s hepatitis drugs, including Sovaldi and the related pill Harvoni which combines Sovaldi with another drug, have transformed the way liver infection is treated, with most patients being cured after a 12-week course.

Nearly a dozen Indian manufacturers are part of Gilead’s licensing pact for low-income countries, including Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd. and Natco.

“I think everybody is very excited about this product because it offers such a wonderful treatment option,” Muktadir said. “But the price is going to come down, and the treatment regimen is only for three months. So, I don’t think it’s going to be a big money-earner.”

Sovaldi was Gilead’s top-selling product last year, bringing in $10.3 billion in sales for the Foster City, California-based company.

Incepta’s copy of Sovaldi, called Hopetavir, is aimed more for international markets than Bangladesh, where hepatitis C prevalence is low, though there is no reliable nationwide data, Muktadir said.

Founded in 1999, Incepta has more than 600 products approved for sale in Bangladesh, ranging from oral solid pills to injectable human insulin, according to the company’s website. The company exports products to more than 40 countries, mostly less regulated markets like Mongolia, Kenya, Somalia, Ethiopia, Mauritania, Democratic Republic of Congo and Afghanistan. It also sells to more regulated markets such as Finland, the U.K., Ukraine and Turkey, according to the site.
Affordable Sources

Doctors Without Borders is “searching for affordable, quality assured sources of sofosbuvir,” said Rohit Malpani, director of policy and analysis at the Access Campaign in Paris. The aid agency can purchase products approved by “stringent” country regulators or by the WHO, he said.

The majority of the world’s hepatitis C sufferers live in middle-income countries, which carry approximately 73 percent of the world burden, according to Doctors Without Borders.

Brazil, home to 2.6 million people with hepatitis C, Thailand, with 1.5 million patients, and Morocco, with 625,000 patients, are all nations not included in Gilead’s agreement with the Indian generics companies.

StephenW

（彭博社） - A $ 10的版本Sovaldi中，吉利德科学公司丙型肝炎的治疗，在美国的售价为1000美元丸，现已在孟加拉国和可以作出自己的方式向世界里，美国公司没有按其他部位'T拥有专利。

Incepta制药有限公司没有从基列许可证和它的版本上个月推出，说总经理阿卜杜勒Muktadir。该公司还计划出售的药物海外，包括东南亚和非洲部分地区。

该仿制药生产商击败市场的一些大的印度竞争对手是由吉利德授权生产Sovaldi低成本版本91个国家的大多是穷人。不包括吉利德执照的国家，包括泰国，马来西亚，摩洛哥，并在Sovaldi没有专利可以受益于廉价的拷贝的新来源国。

Incepta的12周的900美元的价格是一样的价格，在这Gilead公司将提供在印度的药物，其品牌版本。即便如此，孟加拉国的版本显示Gilead公司面临的挑战，从企业它没有那里的药没有申请专利，在国家达成协议。

世界卫生组织说，它与Incepta会谈的资格预审程序，该程序评估药品质量。对于批量采购采摘药时，国际援助机构和国家看这个WHO认证作为一个参考。

基列是“意识到sofosbuvir未经授权的仿制药被提供在市场上，”在一封电子邮件，该公司表示。 “我们专注于尽快使我们的11印度仿制药的合作伙伴推出其授权的仿制药。”
市井

根据世贸组织协议，孟加拉国，作为世界上最不发达的国家之一，没有保护药品专利。

在美国，Sovaldi已经引发了，因为8.4万美元用于其治疗的12周的课程费用的商业健康保险公司的强烈反对。在世界的其他地方，药物的价格已被设置为暴跌为Gilead公司授权开始销售。

海得拉巴为主Natco公司制药有限公司的Gilead公司授权的，在本月推出了通用sofosbuvir在尼泊尔。 Natco公司周一在一份声明说，在19900卢比（$ 318）在尼泊尔一瓶28片售价过的仿制药。

其他一些Sovaldi仿制药除了Incepta的，也没有被授权吉利德，是在埃及的作品，根据埃及倡议的个人权利。

世卫组织正在与Incepta一起在Sovaldi仿制药资格预审的公司在印度和埃及的“一小撮”的会谈，说彼得·拜尔，在基本药物和保健品在日内瓦世卫组织部门的高级顾问。

达卡为基础Incepta目前正准备在其版本sofosbuvir以支持其国际申请提交的质量和溶解的研究，Muktadir说。

“我们为他们只是有点超前，”他的印度竞争对手Muktadir说。 “所以，也许我们应该能够推出这些产品无论它是必需的。在一些非洲国家和一些东南亚国家的负担是非常高的 - 这些都是我们正在寻找在国家“

Incepta的sofosbuvir已被批准用于出售的孟加拉药物监管机构说，穆罕默德·萨拉赫丁在药监总局副导演。
通用的竞争对手

Gilead公司肝炎药物，包括Sovaldi和相关药丸Harvoni结合Sovaldi与另一种药物，已经改变了肝脏感染治疗，有12周的课程后，大部分患者被治愈的方法。

近十几​​印度制造商是Gilead公司的授权协议为低收入国家，包括西普拉有限公司，杂实验室有限公司，Mylan公司实验室有限公司，兰伯西实验室有限公司和Natco公司的一部分。

“我想每个人都非常兴奋，这个产品，因为它提供了这样一个奇妙的治疗选择，”Muktadir说。 “但价格会降下来，治疗方案是只有三个月。所以，我不认为这将是一个很大的金钱收入来源。“

Sovaldi是Gilead公司最畅销产品，去年引进到$ 10.3十亿的销售额为福斯特市，加州的公司。

Sovaldi的Incepta的副本，叫做Hopetavir，目的是为了更比孟加拉国，丙型肝炎发病率较低，但没有可靠的全国性数据的国际市场，Muktadir说。

Incepta成立于1999年，已批准出售孟加拉，从口服固体药片，注射人胰岛素的600多个产品，据该公司的网站上。该公司出口产品到40多个国家，主要是管制较少的市场，如蒙古，肯尼亚，索马里，埃塞俄比亚，毛里塔尼亚，刚果和阿富汗民主共和国。它也销售到更加规范的市场，如芬兰，英国，乌克兰和土耳其，根据现场。
实惠的来源

无国界医生组织的“寻找价格实惠，质量有保证sofosbuvir的人士透露，”罗希特Malpani，政策和分析，在巴黎访问运动总监说。该援助机构可以购买经“严格”的国家监管机构或世界卫生组织的产品，他说。

世界上大多数的丙型肝炎患者生活在中等收入国家，其中大约进行73％的全球负担，根据无国界医生组织。

巴西主场260万人患有丙型肝炎，泰国，有150万患者，和摩洛哥，与625000例，是不包括在Gilead公司与印度仿制药公司达成协议所有国家。

白眼望苍天

白眼望苍天

mengjierdaigou

孟加拉吉二是孟加拉第二大制药企业Incepta公司生产的，质量有保障，建议大家使用

盆垂草

阳光何时照在中国人的头上？期盼期盼

StephenW

回复 盆垂草 的帖子

治愈丙型肝炎药物多, 新的正在发展 - 只太贵.

盆垂草

谢谢楼主的回复，等我们的收入能够吃的起，不知道何年何月？感谢。