The British company's Cervarix vaccine will compete with Merck & Co's blockbuster Gardasil shot. Both injections provide protection against human papillomavirus, or HPV, which causes cervical cancer and genital warts.
Some analysts say it will be hard to compete against Merck's three-year head start in the U.S. market. Gardasil won FDA clearance in 2006, while the launch of Cervarix was stalled after the Food and Drug Administration asked for more information following Glaxo's initial application in 2007.
The Merck vaccine had global sales of $1.4 billion in 2008, compared with more than $200 million for Cervarix.
In the United States, cervical cancer is often caught early, while the disease is treatable, through Pap smears. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.
Gardasil has generated controversy over potential side effects as well as the cost of about $360 for preventing a disease that is treatable if caught early.
The FDA and Centers for Disease Control and Prevention say Gardasil remains safe with no unusual complications, and problems such fainting and nausea remain rare.
Both Cervarix and Gardasil fight two HPV strains that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts.
(Reporting by Lisa Richwine; Editing by Lisa Von Ahn)
((Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: GLAXOSMITHKLINE CERVARIX/USA
* Vaccine to be available later this year
* Glaxo's Cervarix competes with Merck's Gardasil
* Gardasil wins U.S. OK for males to prevent warts
(Adds approval for Merck vaccine in males)
By Lisa Richwine
LOS ANGELES, Oct 16 (Reuters) - GlaxoSmithKline Plc won U.S. approval on Friday to sell a cervical cancer vaccine for girls and young women, while a rival Merck & Co shot was cleared for preventing genital warts in males.
British company Glaxo said the U.S. Food and Drug Administration cleared the Cervarix vaccine for females ages 10 to 25 and it expects the new shot to be available in the United States later this year.
Merck's competing cervical cancer vaccine, Gardasil, debuted on the U.S. market in 2006. On Friday, the FDA approved Gardasil for preventing genital warts in boys and men ages nine through 26.
Both vaccines fight two strains of the sexually transmitted human papillomavirus (HPV) that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts. It is unclear how long protection lasts or whether booster shots will be needed.
Some analysts say it will be hard for Glaxo compete against Merck's three-year head start in the U.S. market. Gardasil won FDA clearance in 2006, while the launch of Cervarix was stalled after the Food and Drug Administration asked for more information following Glaxo's initial application in 2007.
Cervarix received a boost on Friday by winning the first approval for a cervical cancer vaccine in Japan, the world's second-largest pharmaceutical market after the United States.
Consensus forecasts suggest Cervarix will generate worldwide sales of just over $1 billion in 2013, according to Thomson Pharma, equivalent to about 2 percent of expected Glaxo sales for that year.
Merck's Gardasil had global sales of $1.4 billion in 2008.
Both Cervarix and Gardasil fight two HPV strains that cause about 70 percent of cervical cancers.
In studies, Cervarix was 93 percent effective in preventing a pre-cancerous condition associated with those two strains. Cervarix also fought some other HPV strains. Studies showed it was 89 percent effective in preventing precancerous lesions from the third most common HPV type to cause cancer.
Neither Gardasil nor Cervarix fights all types of HPV.
In the United States, cervical cancer is often caught early, while the disease is treatable, through Pap smears. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.
Gardasil has generated controversy over potential side effects as well as the cost of about $360 for preventing a disease that is treatable when caught early.
GlaxoSmithKline spokeswoman Sarah Alspach said the company has not yet released the price for Cervarix.
The FDA and Centers for Disease Control and Prevention say Gardasil remains safe with no unusual complications, and problems such as fainting and nausea remain rare.
For Cervarix, Glaxo said the most common adverse reactions include injection site pain and swelling, fatigue and headaches.
FDA advisers who met in September said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring after approval to see whether there was a link to the vaccine.
Glaxo shares eased 1 cent to $41.27 in New York Stock Exchange trading, while shares of Merck declined 8 cents to $33.22..
(Reporting by Lisa Richwine; Editing by Lisa Von Ahn and Gerald E. McCormick)
((Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: GLAXOSMITHKLINE CERVARIX/USA
* Vaccine to be available later this year
* Glaxo's Cervarix competes with Merck's Gardasil
* Gardasil wins U.S. OK for males to prevent warts
(Adds Merck, FDA comments)
By Lisa Richwine
LOS ANGELES, Oct 16 (Reuters) - GlaxoSmithKline Plc won U.S. approval on Friday to sell a cervical cancer vaccine for girls and young women, while a rival Merck & Co shot was cleared for preventing genital warts in males.
Glaxo said the U.S. Food and Drug Administration cleared the Cervarix vaccine for females ages 10 to 25.
Merck's competing cervical cancer vaccine, Gardasil, debuted on the U.S. market in 2006 and generated some controversy over its cost and potential side effects. On Friday, the FDA approved Gardasil for preventing genital warts in boys and men ages 9 through 26.
Both vaccines fight two strains of the sexually transmitted human papillomavirus (HPV) that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts. It is unclear how long protection lasts or whether booster shots will be needed.
Some analysts say it will be hard for Glaxo to compete against Merck's three-year head start in the U.S. market. Glaxo's original bid in 2007 stalled when the FDA sought more data.
Cervarix got a boost on Friday by winning the first approval for a cervical cancer vaccine in Japan, the world's second-largest pharmaceutical market after the United States.
Consensus forecasts suggest Cervarix will generate worldwide sales of just over $1 billion in 2013, according to Thomson Pharma, equivalent to about 2 percent of expected Glaxo sales for that year.
Merck's Gardasil had global sales of $1.4 billion in 2008. The company said Centers for Disease Control and Prevention advisory panel was expected to vote next Wednesday on whether to recommend Gardasil for males.
Both Cervarix and Gardasil fight two HPV strains that cause about 70 percent of cervical cancers.
In Glaxo's studies, Cervarix was 93 percent effective in preventing a pre-cancerous condition associated with the two strains. Cervarix also fought some other strains. It was 89 percent effective in preventing precancerous lesions from the third most common HPV type to cause cancer, Glaxo said.
Neither Gardasil nor Cervarix fights all types of HPV.
In the United States, cervical cancer is often caught early through Pap smears. Still, about 4,000 U.S. women die each year from the disease. Global deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.
Some critics question if it is worth the cost to vaccinate for cervical cancer when its is largely treatable if caught early. Immunizing boys for genital warts also raised concerns since the warts often clear up without treatment.
Gardasil costs about $360, while Glaxo has not announced a price for Cervarix.
Glaxo said Cervarix should be available in the United States later this year. The most common adverse reactions in studies included injection site pain, fatigue and headaches.
FDA advisers in September said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring after approval to see if there was a link to the vaccine.
Cervarix contains a novel additive designed to boost the immune response. In a Glaxo study, Cervarix produced more antibodies than Gardasil but the researchers did not study if the higher levels provided more protection against cancer.
On Gardasil, the FDA said Merck will run post-approval studies to obtain more information about the safety and effectiveness in men and boys. The FDA has repeatedly said Gardasil remains safe with no unusual complications.
Glaxo shares fell 8 cents to close at $41.20, and Merck shares fell 9 cents to close at $33.21, both on the New York Stock Exchange.
(Reporting by Lisa Richwine; Editing by Lisa Von Ahn, Gerald E. McCormick and Carol Bishopric) Keywords: GLAXOSMITHKLINE CERVARIX/USA (Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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