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Gardasil 9收获EMA祝福 赛诺菲默沙东梦里都会笑出声!

来源:生物谷 2015-04-03 15:18

2015年4月2日讯 /生物谷BIOON/ --本周默沙东和赛诺菲两家公司迎来了一个复活节"大礼包"!几天前欧盟医药管理部门EMA刚刚批准了两家公司开发的人乳头瘤病毒疫苗Gardasil 9,并计划将其提交至欧盟委员会进行审批。

Gardasil 9是现有同名疫苗的进阶版,这种疫苗除了包含老版本疫苗抗6、11、16、18型乳头瘤病毒以外,还增添了对31、33、45、52和58五种亚型乳头瘤病毒的保护能力,而数据显示这五种乳头瘤病毒导致了约20%的宫颈癌病例的发生。

默沙东公和赛诺菲为推动Gardasil 9可谓是不遗余力,两家公司此前向EMA提交了四项研究数据以证明这种新疫苗对上述九种病毒亚型的有效性,同时开展了一项有超过23000人参加的研究证明了这种疫苗的安全性。基于上述数据,EMA最终才送出了自己的祝福。

此前美国FDA已经于去年的12月份批准了这种疫苗的上市,今年二月份美国CDC下属的专家委员会也做出了建议批准该疫苗上市的决定。

两家生物巨头对收获欧美两大市场的通行证自然是喜不自胜。赛诺菲公司的发言人表示Gardasil 9的上市将标志着预防乳头瘤病毒的新时代,这种疫苗将会把这九种病毒亚型的感染降低80%之多!

按照协议规定,默沙东公司将获得Gardasil 9在美国市场的销售权,而赛诺菲公司则垄断了欧洲市场。此前FDA批准这一疫苗时有分析人士预计该疫苗的年销售额将突破19亿美元之多,而此次EMA对Gardasil 9的祝福无疑又会使这一数字节节攀升,这下两家的CEO恐怕晚上睡觉的时候都会笑出声来。(生物谷Bioon.com)

详细英文报道:

Merck's ($MRK) new-and-improvedGardasil is making headway in Europe with the word late last week that the European Medicines Agency (EMA) has recommended the jab against 9 types of human papillomavirus (HPV) and will send its blessing to the European Commission.

Gardasil 9 was recommended by the EMA for routine vaccination against HPV types 31, 33, 45, 52 and 58--which cause nearly 20% of cases of cervical cancer--as well as types 6, 11, 16 and 18, which the original Gardasil blocked. The vaccine, sold by Merck in the U.S. and Sanofi Pasteur MSD in Europe, immunizes against the most HPV types of any available vaccine, Sanofi Pasteur said in its release.

"We anticipate that, if approved, Gardasil 9 will represent a major step forward in HPV prevention. Gardasil 9 has the potential to help prevent over 80% of genital cancers caused by HPV and to reduce the transmission of the 9 HPV types," Dr. Jean-Paul Kress, president of Sanofi Pasteur MSD, said in a statement.

The EMA based its decision on four main studies testing the vaccine's efficacy against all 9 HPV types; safety was evaluated in more than 23,000 people.

The recommendation will be sent to the European Commission to decide on EU-wide marketing authorization. With European Commission approval, pricing and reimbursement negotiations can take place with member nations.

The FDA approved the jab in December 2014, and now with the CDC's Advisory Committee on Immunization Practices' blessing in February, Gardasil 9 can be used on a large scale against HPV in the U.S.

Such advancements are likely welcome news to Merck and Sanofi Pasteur. As of the FDA's approval, analysts expected the jab to bring in peak sales of $1.9 billion per year, though that will come at the expense of its predecessor. Leerink Partners analysts have estimated that sales of the old vaccine will sink to just $525 million in 2018 after reaching $1.83 billion in 2013; at one time, forecasts for Gardasil went as high as $10 billion, but sex-related stigma and other factors dampened those sales hopes.

 

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