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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。
New Delhi -- September 15, 2014 -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies -- Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd., and Strides Arcolab Ltd. -- to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population.
"Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries," commented Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi by the U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir; it is an investigational agent and its safety and efficacy have not been established.