迫于压力 吉利德授权7家印度仿制商生产Sovaldi仿制药

迫于压力 吉利德授权7家印度仿制商生产Sovaldi仿制药

                               
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发布日期：2014-09-16  来源：生物谷  

Sovaldi是丙肝明星药物，上市半年突破60亿美元。近日，吉利德授权印度仿制商生产Sovaldi仿制药，业界认为，此举更多的或是对印度强仿大环境的无奈之举。

                               
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吉利德（Gilead）周一宣布，已经与多家仿制药商达成合作协议，生产丙肝明星药物Sovaldi的仿制药及另一种实验性药物，销往91个发展中国家。

Sovaldi是吉利德名副其实的印钞机，2014上半年的销售额达到了惊人的58亿美元。Sovaldi于2013年12月在美国上市，自诞生之日起便成为行业关注的焦点，其84000美元/疗程（1000美元/片）的定价也饱受各方争议。美国众议院、患者维权组织等机构曾强烈呼吁Sovaldi降价，而吉利德则坚持不降，并称从长远来看，该药将为纳税人节省大笔开支。

在美国，约有300-400万丙肝患者。在Sovaldi上市之前，丙肝的临床标准治疗需要每日服用多达12片药物，同时必须注射干扰素，该标准疗法的临床治愈率仅为75%左右，并可引起类似流感症状的严重副作用。而Sovaldi的副作用少，且治愈率高达80-90%，因此一上市便迅速获得了临床医生的青睐。

今年8月，吉利德接受印度时报采访时表示，将在印度以1%的价格销售Sovaldi，即900美元/疗程，折扣高达99%，遭到了美国评论家的强烈声讨。但吉利德表示，该定价是基于面对低收入国家的定价策略。但业界认为，吉利德此举，更多的或是出于对印度知识产权大环境的无奈之举。如果印度政府行行使强制仿制许可权，吉利德不仅丧失了在印度的直接销售，甚至有失去Sovaldi专利的风险。

关于此次Sovaldi仿制合作协议，吉利德并没有透露Sovaldi仿制药在发展中国家市场的售价，但表示，协议所覆盖的国家中，丙肝患者总数超过1亿例，超过了全球丙肝患者总数的一半。吉利德表示，此次与仿制药商达成的协议，对于吉利德在这些发展中国家人道主义项目的推进至关重要。

此次合作名单中有7家印度仿制药公司，其中包括迈兰（Mylan）、兰伯西（Ranbaxy）和Cadila保健公司。迈兰称，该笔交易将允许旗下子公司生产Sovaldi的仿制药，并将帮助解决数以百万计患者的医疗需求。这些公司将向吉利德支付基于销售额的特许权使用费，同时吉利德将转让Sovaldi生产技术，以帮助其迅速开始生产。

此次合作的协议，还包括吉利德另一种丙肝复方药物，该药由Sovaldi和另一种抗病毒药物ledipasvir组成，目前该复方药正在接受FDA和欧洲药品管理局（EMA）的审查。（生物谷Bioon.com）

英文原文：Gilead to license generic version of Sovaldi

Gilead Sciences has reached a deal with several generic drugmakers to produce a cheaper version of its popular, $1,000-per-pill hepatitis C drug Sovaldi for use in developing countries.

Gilead said Monday that the India-based companies will make a generic version of Sovaldi, also known as sofosbuvir, and another investigational drug for distribution in 91 countries.

Sovaldi hit the U.S. market late last year and has been hailed as a breakthrough treatment. But Gilead has taken criticism over its cost, which can amount to $84,000 for a full course of treatment.

Hepatitis C is a liver-destroying virus carried by an estimated 3 million to 4 million Americans. Until late last year, the standard treatments required taking up to 12 pills a day, alongside antiviral drug injections that can cause flu-like symptoms. That approach cured only about 75 percent of patients.

U.S. regulators approved Sovaldi last December, and it was quickly embraced by physicians based on its once-a-day pill regimen and increased effectiveness, curing between 80 percent and 90 percent of patients.

The drug is expected to generate several billion dollars in sales this year alone for Foster City, California-based Gilead. The drugmaker has said that Sovaldi's costs for payers will be recouped over the long term as fewer patients suffer liver failure and transplant complications. It also has said it offers financial assistance to patients who cannot afford the drug and related insurance costs.

View galleryFILE - This Thursday, March 12, 2009, file photo, shows …

FILE - This Thursday, March 12, 2009, file photo, shows Gilead Sciences Inc. headquarters in Foster  …

Even so, Congressional leaders have criticized the drug's pricing, and some state-based Medicaid plans are scaling back access to the treatment.

Gilead Sciences Inc. did not detail the price on the generic version of Sovaldi to be sold in developing markets. It said countries covered by the agreement account for more than 100 million people living with hepatitis C. That represents more than half of the total global, infected population.

"These agreements are essential to advancing the goals of our humanitarian program in these countries," Gilead Executive Vice President Gregg H. Alton said in a statement from the company.

One of the generic drugmakers involved, Mylan Inc., said the deal will allow its subsidiary to offer access to "a more affordable version" of the drug to help meet the unmet medical needs of millions of patients.

The seven India-based companies — a list that also includes Ranbaxy Laboratories Ltd. and Cadila Healthcare Ltd. — will pay sales royalties to Gilead and receive a technology transfer that helps them start production quickly.

Gilead's agreement also covers another treatment, a single tablet combination of sofosbuvir and another antiviral drug, ledipasvir. Regulators in both the United States and Europe are currently reviewing that combination.

Shares of Gilead dropped $2.83, or 2.7 percent, to $100.83 in morning trading Monday. But the stock had already climbed 38 percent so far this year, as of Friday's close.

原文链接http://news.bioon.com/article/6658811.html。

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