Glaxo Still Chasing FDA Approval For Cervarix
The FDA’s approval for the ‘other’ HPV-vaccine, Cervarix is still delayed. GlaxoSmithKline, the world’s second-largest drugmaker, requested a ‘priority’ review, potentially prompting an approval decision and sale of the Cervarix vaccine by the end of 2007, said James Tursi, Glaxo’s director of medical affairs for cervical cancer vaccines, at a medical meeting in San Diego.
Glaxo filed for U.S. clearance for Cervarix in March, nine months after Merck won approval for Gardasil, which generated $365 million in sales in first quarter 2007. Gardasil, which protects against the Human Papillomavirus, Or HPV, is one of Merck’s most important new products as it seeks to offset $800 million in lost sales from its cholesterol pill Zocor, which lost patent protection in 2006.
“Gardasil and Cervarix are both nearly 100 percent effective against the two types of HPV that cause the majority of cervical cancer cases,” said Kevin Ault, an obstetrician and gynecologist at Emory University in Atlanta who has worked as a consultant for both companies. “Based on the data we have right now, I would say much of the choice could come down to price.”
Shares of Glaxo, based in London, fell 43 cents to $57.39 at 4 p.m. in New York Stock Exchange composite trading. The stock of Merck, based in Whitehouse Station, New Jersey, fell 19 cents to $52.05.
Both vaccines protect against forms of HPV that can cause 70 percent of cervical cancer cases.
Vaccine Costs
Gardasil, given in a series of three shots, costs $120 per injection. Glaxo hasn’t disclosed how much it will charge for Cervarix. The vaccines may compete for as much as $8 billion in annual revenue by 2010, analyst Navid Malik of Collins Stewart in London said in a research note in March.
Generally, the FDA grants priority review to products that serve unmet medical needs. Regulators take about six months to review drugs granted priority designation, compared with at least 10 months for products under standard review.
Glaxo discussed selected test results for Cervarix yesterday at a meeting of the American College of Obstetricians and Gynecologists. The data were first reported last week at a medical meeting in Portugal.
In women aged 15 to 55, Cervarix protected against the two HPV types that are most responsible for cervical cancer for at least 18 months at the site of infection on the cervix, Glaxo said today.
10 Years of Immunity
“We estimate, based what we know now about how the vaccine works, that it can provide immunity for 10 years,” said Tino Schwarz, study author and head of the Central Laboratory at the Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg in Germany.
The vaccine was 100 percent effective for as much as 5.5 years against types 16 and 18 of the human papillomavirus that causes cervical cancer and maintained an immune response at least 11 times natural levels, Glaxo reported in April.
Cervarix protected against HPV types 45 and 31 for the same duration, was 68 percent effective against pre-cancerous lesions and was 38 percent effective against abnormal Pap smears, Glaxo said. The four strains cause 80 percent of cervical cancers.
Cervical cancer is the second-most common cancer among women and kills 250,000 women a year, according to the World Health Organization. HPV, which causes cervical cancer, is a sexually transmitted virus, so the goal is to vaccinate girls before they become sexually active.
500,000 Cases
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.
While the two vaccines are similar, there some differences. Gardasil is also designed to work against two strains of HPV that cause genital warts. Cervarix uses a booster that may make it last longer.
Both products use vaccine boosters called adjuvants, a substance which enhances the ability of an antigen to stimulate the immune system. Antigens are foreign substances in the body that cause the immune system to form an antibody that responds only to that particular antigen.
Merck’s Gardasil uses a traditional aluminum adjuvant. Glaxo’s Cervarix uses a proprietary adjuvant known as AS04, which the company is seeking to prove makes its vaccine better.
Stronger Immune Response
A study published in the journal Vaccine last year found the immune response to Glaxo’s vaccine was stronger and more sustained when made with AS04 than when made with the conventional adjuvant.
Glaxo will present more detailed data on Cervarix next month at a meeting of the American Society of Clinical Oncology.
Gardasil has drawn some controversy since the Merck drug was approved. Groups, including the conservative political organization Focus on the Family, have opposed making the vaccine mandatory because HPV isn’t spread by casual contact like the germs that cause measles or polio. The American Academy of Pediatrics also said there wasn’t enough funding to pay for the $360 vaccine or public acceptance to make it a requirement.
Among growing criticism, Merck said in February it would stop lobbying state officials to require that girls receive the company’s cervical cancer vaccine before they can attend school
Source: Bloomberg News
