Merck, Glaxo Prepare For Hpv Vaccine Battle With U.s. Approvals
The Food and Drug Administration authorized sales of Gardasil to prevent genital warts in males ages 9 to 26 and Glaxos Cervarix to prevent cervical cancer in females ages 10 to 25, the companies said today in separate statements. Gardasil has been approved in the U.S. since 2006 and is part of routine vaccinations for school-age girls.
The shots target strains of human papillomavirus, or HPV, a common sexually transmitted virus that can cause cancer and serious infections. Concerns about Cervarixs safety contributed to a regulatory delay in 2007, helping give Merck a head start on the U.S. market. Outside advisers to the FDA on Sept. 9 backed Cervarix as well as Mercks proposal to expand Gardasils market.
“Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in the United States, in both males and females,” said Anna Giuliano, a program leader in risk assessment, detection and intervention at the Moffitt Cancer Center in Tampa, Florida, in Mercks statement.
Broader use could revive Gardasils sales, which declined 5 percent last year to $1.4 billion amid questions about side effects and cost.
Approval in boys may add as much as $200 million to $300 million in annual sales for Merck, of Whitehouse Station, New Jersey, Leerink Swann & Co. analyst Seamus Fernandez said in a research report last month.
Challenge for Glaxo
London-based Glaxo faces a challenge in winning doctors and parents support for Cervarix because Gardasil also protects against genital warts. Cervarix is cleared in 100 countries, including approval today in Japan, and had sales of 125 million pounds ($232 million) last year, about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales worth 603 million pounds in 2013.
Demand for both vaccines will likely be affected by recommendations of the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices next week. The 15-member panel that sets national guidelines plans to review Cervarix for girls and Gardasil for boys at an Oct. 21 meeting in Atlanta.
Twenty million Americans are infected with HPV, and most will be able to fight off the infection naturally. This year, an estimated 11,270 new cases of cervical cancer will be diagnosed in the U.S. and 4,070 women will die of the disease, according to the National Cancer Institute, a U.S. agency. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, according to the CDC.
Three Doses
Gardasil and Cervarix are given in three doses during a six-month period to trigger immune responses that help protect against the two HPV strains responsible for most U.S. cervical cancer cases. Gardasil also protects against two additional strains of HPV that cause 90 percent of genital warts.
It would cost more than $100,000 to vaccinate enough boys with Gardasil to get one year of additional life compared with less than $50,000 for girls, according to a study by Harvard University researchers presented in June. Mercks studies show it would cost $50,000 for boys and girls at a price of $400 per vaccine.
Paying for Shots
Merck will expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19- to 26- year-old men without health insurance and those with private insurance with partial or no coverage for the shots, according to the companys statement.
Glaxos studies showed a slight increase in miscarriages among young women who took Cervarix. Outside advisers to the FDA who backed the safety and effectiveness of Cervarix said Glaxos plan to register patients and monitor for pregnancies would mitigate any potential risks.
American depositary receipts of Glaxo, each representing two ordinary shares, fell 8 cents to $41.20 at 4:01 p.m. in New York Stock Exchange composite trading. Merck dropped 9 cents to $33.21.
Merck, Glaxo Prepare For Hpv Vaccine Battle With U.s. Approvals
The Food and Drug Administration authorized sales of Gardasil to prevent genital warts in males ages 9 to 26 and Glaxos Cervarix to prevent cervical cancer in females ages 10 to 25, the companies said today in separate statements. Gardasil has been approved in the U.S. since 2006 and is part of routine vaccinations for school-age girls.
The shots target strains of human papillomavirus, or HPV, a common sexually transmitted virus that can cause cancer and serious infections. Concerns about Cervarixs safety contributed to a regulatory delay in 2007, helping give Merck a head start on the U.S. market. Outside advisers to the FDA on Sept. 9 backed Cervarix as well as Mercks proposal to expand Gardasils market.
“Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in the United States, in both males and females,” said Anna Giuliano, a program leader in risk assessment, detection and intervention at the Moffitt Cancer Center in Tampa, Florida, in Mercks statement.
Broader use could revive Gardasils sales, which declined 5 percent last year to $1.4 billion amid questions about side effects and cost.
Approval in boys may add as much as $200 million to $300 million in annual sales for Merck, of Whitehouse Station, New Jersey, Leerink Swann & Co. analyst Seamus Fernandez said in a research report last month.
Challenge for Glaxo
London-based Glaxo faces a challenge in winning doctors and parents support for Cervarix because Gardasil also protects against genital warts. Cervarix is cleared in 100 countries, including approval today in Japan, and had sales of 125 million pounds ($232 million) last year, about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales worth 603 million pounds in 2013.
Demand for both vaccines will likely be affected by recommendations of the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices next week. The 15-member panel that sets national guidelines plans to review Cervarix for girls and Gardasil for boys at an Oct. 21 meeting in Atlanta.
Twenty million Americans are infected with HPV, and most will be able to fight off the infection naturally. This year, an estimated 11,270 new cases of cervical cancer will be diagnosed in the U.S. and 4,070 women will die of the disease, according to the National Cancer Institute, a U.S. agency. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, according to the CDC.
Three Doses
Gardasil and Cervarix are given in three doses during a six-month period to trigger immune responses that help protect against the two HPV strains responsible for most U.S. cervical cancer cases. Gardasil also protects against two additional strains of HPV that cause 90 percent of genital warts.
It would cost more than $100,000 to vaccinate enough boys with Gardasil to get one year of additional life compared with less than $50,000 for girls, according to a study by Harvard University researchers presented in June. Mercks studies show it would cost $50,000 for boys and girls at a price of $400 per vaccine.
Paying for Shots
Merck will expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19- to 26- year-old men without health insurance and those with private insurance with partial or no coverage for the shots, according to the companys statement.
Glaxos studies showed a slight increase in miscarriages among young women who took Cervarix. Outside advisers to the FDA who backed the safety and effectiveness of Cervarix said Glaxos plan to register patients and monitor for pregnancies would mitigate any potential risks.
American depositary receipts of Glaxo, each representing two ordinary shares, fell 8 cents to $41.20 at 4:01 p.m. in New York Stock Exchange composite trading. Merck dropped 9 cents to $33.21.