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【drug-news】葛兰素子宫颈癌疫苗没有获得FDA 优先
Glaxo Cervical Cancer Vaccine Doesn't Get FDA Priority Review
By Andrea Gerlin
May 30 (Bloomberg) -- GlaxoSmithKline Plc's Cervarix cervical cancer vaccine won't get priority review from U.S. regulators, putting the U.K. drugmaker's product further behind a rival from Merck & Co.
The U.S. Food and Drug Administration didn't grant the accelerated review to Glaxo's Cervarix, which protects against the sexually transmitted human papillomavirus, or HPV, said Liad Diamond, a spokeswoman for the London-based company, in a phone interview today. Priority reviews are given to products that serve an unmet need or represent significant improvements over current therapies.
Glaxo, the world's second-largest drugmaker after Pfizer Inc., filed for U.S. clearance for Cervarix in March, four months later than it planned and nine months after Merck won approval for its Gardasil cervical cancer vaccine. Gardasil went on sale in the U.S., Europe and Australia last year and brought in $365 million in sales for Merck in the 2007 first quarter.
Both vaccines protect against forms of HPV that can cause 70 percent of cervical cancers. Gardasil, given in a series of three shots, costs $120 a dose. Glaxo hasn't disclosed how much it will charge for Cervarix. The vaccine has the potential to generate $1.5 billion a year for Glaxo by 2010 and $5 billion a year at its peak, according to a May 15 research note by analyst Navid Malik of Collins Stewart in London.
The company expects the FDA to make a decision on whether to approve the vaccine by January 2008, the standard 10-month review period. The company plans to present study results on Cervarix next month at a meeting of the American Society of Clinical Oncology.
Glaxo is also awaiting a decision from the European Medicines Agency on the application it filed for Cervarix in Europe in March 2006.
Cervical cancer is the second-most-common cancer among women and kills 250,000 women a year, according to the World Health Organization. About 500,000 cases of the disease are reported every year, 80 percent of them in developing countries, the Geneva-based agency said.
About 10,000 women were diagnosed with cervical cancer in the U.S. in 2006 and nearly 4,000 died from the disease, according to the American Cancer Society. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Glaxo Cervical Cancer Vaccine Doesn't Get FDA Priority Review
葛兰素子宫颈癌疫苗没有获得FDA 优先权
May 30 (Bloomberg) -- GlaxoSmithKline Plc's Cervarix cervical cancer vaccine won't get priority review from U.S. regulators, putting the U.K. drugmaker's product further behind a rival from Merck & Co.
葛兰素子宫颈癌疫苗Cervarix没有获得FDA 优先权，这使其远落后于竞争对手默克公司。
The U.S. Food and Drug Administration didn't grant the accelerated review to Glaxo's Cervarix, which protects against the sexually transmitted human papillomavirus, or HPV, said Liad Diamond, a spokeswoman for the London-based company, in a phone interview today. Priority reviews are given to products that serve an unmet need or represent significant improvements over current therapies.
葛兰素英国总部的女发言人在一个电话会议中提到，美国FDA并不打算对子宫颈癌疫苗Cervarix加速审批，该疫苗主要用于预防通过性传播的人乳头状瘤病毒（HPV）。只有那些非常缺乏或能明显改善目前治疗手段的药物才能获得审批优先权。
Glaxo, the world's second-largest drugmaker after Pfizer Inc., filed for U.S. clearance for Cervarix in March, four months later than it planned and nine months after Merck won approval for its Gardasil cervical cancer vaccine. Gardasil went on sale in the U.S., Europe and Australia last year and brought in $365 million in sales for Merck in the 2007 first quarter.
仅此于美国辉瑞公司的全球第二大制药公司、葛兰素在3月份就向美国FDA 递交了有关Cervarix疫苗的申请，这比预期的已晚了4个月；然而默克公司的Gardasil cervical抗癌疫苗在9个月前就获得了FDA的批准，该疫苗去年就已在美国、欧洲和澳洲上市，并且在2007年首季度为默克带来了3.65亿美元的销售收入。
Both vaccines protect against forms of HPV that can cause 70 percent of cervical cancers. Gardasil, given in a series of three shots, costs $120 a dose. Glaxo hasn't disclosed how much it will charge for Cervarix. The vaccine has the potential to generate $1.5 billion a year for Glaxo by 2010 and $5 billion a year at its peak, according to a May 15 research note by analyst Navid Malik of Collins Stewart in London.
两中疫苗都用于预防人乳头状瘤病毒的感染，这种病毒直接导致了70%的宫颈癌。Gardasil疫苗需连续注射3次，每次120美元。葛兰素公司没有透露他们的产品价格。据伦敦经纪公司Collins Stewart的分析师Navid Malik的估计，Glaxo疫苗能为葛兰素每年带来15亿美元的收益，并且年销售峰值将达到50亿美元。
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作者:admin@医学,生命科学 2011-04-17 17:11
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