Post by blackcrowheart on Mar 30, 2007 8:50:05 GMT -5
Cancer Vaccine to Test on American Indian Girls
GSK confident as it puts cancer vaccine to test
Sabine Vollmer, Staff Writer
GlaxoSmithKline is taking a risky step as it prepares to seek regulatory
approval for its cancer vaccine Cervarix.
The British drug maker, with a U.S. headquarters in Research Triangle Park,
is announcing today the start of a study to compare Cervarix to its
competitor, Merck's Gardasil. Head-to-head studies are rare, because results can pack
unexpected surprises. But Gardasil has been on the market for about six
months, and GSK is under pressure to catch up, said Gbola Amusa, a pharmaceutical
analyst with Sanford Bernstein in London.
Are the two vaccines different? Both were developed to protect girls and
young women against the human papilloma virus, the most common sexually
transmitted disease in the United States. According to the Centers for Disease
Control and Prevention in Atlanta, one in six of those infected will develop
genital warts; one in 1,000 will be diagnosed with cervical cancer, a disease that
kills about one-third of its victims. Gardasil targets four strains of the
virus, two known to trigger cancer and two that can cause genital warts.
Cervarix targets only the two cancer triggers but has a chemical substance that
boosts the vaccine's strength.
Why push a comparison? Merck's head start has given the company control of
the market. Gardasil, which was approved by regulators in June, was added to
the federal Vaccines for Children program in the fall. That made it available
for free to children who are uninsured, underinsured, on Medicaid or American
Indian, which is about half of all 9- to 18-year-old girls.
If GSK's study confirms that Cervarix is stronger and lasts longer, it could
set the two vaccines apart and convince doctors and consumers that Cervarix
is a better choice. GSK is confident the results of the head-to-head study
will favor Cervarix, said Brian Lortie, a GSK executive.
What's next: The two vaccines will be tested on 1,000 women worldwide and
results reported in about a year. GSK plans to ask for FDA approval in April and
bring the vaccine to market before the end of the year.
GSK confident as it puts cancer vaccine to test
Sabine Vollmer, Staff Writer
GlaxoSmithKline is taking a risky step as it prepares to seek regulatory
approval for its cancer vaccine Cervarix.
The British drug maker, with a U.S. headquarters in Research Triangle Park,
is announcing today the start of a study to compare Cervarix to its
competitor, Merck's Gardasil. Head-to-head studies are rare, because results can pack
unexpected surprises. But Gardasil has been on the market for about six
months, and GSK is under pressure to catch up, said Gbola Amusa, a pharmaceutical
analyst with Sanford Bernstein in London.
Are the two vaccines different? Both were developed to protect girls and
young women against the human papilloma virus, the most common sexually
transmitted disease in the United States. According to the Centers for Disease
Control and Prevention in Atlanta, one in six of those infected will develop
genital warts; one in 1,000 will be diagnosed with cervical cancer, a disease that
kills about one-third of its victims. Gardasil targets four strains of the
virus, two known to trigger cancer and two that can cause genital warts.
Cervarix targets only the two cancer triggers but has a chemical substance that
boosts the vaccine's strength.
Why push a comparison? Merck's head start has given the company control of
the market. Gardasil, which was approved by regulators in June, was added to
the federal Vaccines for Children program in the fall. That made it available
for free to children who are uninsured, underinsured, on Medicaid or American
Indian, which is about half of all 9- to 18-year-old girls.
If GSK's study confirms that Cervarix is stronger and lasts longer, it could
set the two vaccines apart and convince doctors and consumers that Cervarix
is a better choice. GSK is confident the results of the head-to-head study
will favor Cervarix, said Brian Lortie, a GSK executive.
What's next: The two vaccines will be tested on 1,000 women worldwide and
results reported in about a year. GSK plans to ask for FDA approval in April and
bring the vaccine to market before the end of the year.