【drug-news】葛兰素子宫颈癌疫苗没有获得FDA 优先权
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http://www.bloomberg.com/apps/news?pid=20601103&sid=aq_d7Oyqqvjo&refer=us
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.
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.
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