GSK to conduct head-to-head trial as stakes rise in vaccine sector

GlaxoSmithKline will pit its experimental cervical cancer vaccine Cervarix against Merck’s Gardasil in a head-to-head clinical trial, the drugmaker said. The study, set to enroll more than 1,000 women, is a somewhat risky move for GSK. The results could support Gardasil, which was approved last June and is expected to generate upward of $700 million in sales this year. But favorable data could give Cervarix, which is still in development, a marketing edge. The company plans to submit the vaccine to the FDA in 2009, and results would become available by then. In 2009, Gardasil will generate $2.5 billion in sales, compared with $850 million for Cervarix, according to a report from investment bank Friedman, Billings, Ramsey cited by Forbes. From there, sales of both will level off. The stakes for the two drug companies rose recently when the American Cancer Society issued recommendations that girls should get the new vaccine for human papilloma virus (HPV) at age 11-12. The American Academy of Pediatrics did the same when it updated its own immunization schedule earlier this year. HPV types 16 and 18 are responsible for at least 70% of all cervical cancers worldwide. GSK’s phase III trial will be designed to compare the vaccine’s immune responses to types 16 and 18, as well as to other cancer-causing HPV types. Merck’s vaccine is designed to protect against four strains of HPV; GSK is testing its vaccine to protect against two. Cervarix’s proprietary adjuvant system stimulates “a more robust immune memory response,” according to GSK. Merck says its technology is well established. Meanwhile, legislation proposed in West Virginia would require girls entering sixth grade to get vaccinations to protect them against HPV. Delegate Bonnie Brown, D-Kanawha, promoted the legislation that would mandate vaccination against the disease. “It is important that as many girls as possible have access to this lifesaving technology,” Brown said during a news conference in Charleston, WV. According to a study released by Women in Government, a nonprofit, bipartisan organization of female state legislators, West Virginia’s cervical cancer fatality rate is the second highest in the US, behind only Washington, DC. Four women per 100,000 die of cervical cancer in the state every year, according to the study. Resources will be a central question for the legislation, according to an Associated Press report. The vaccines cost $120 per dose and the course of treatment requires three doses. This year, there are 10,235 sixth grade girls in West Virginia, according to the state Dept. of Education. At $360 per course of treatment, that’s a bill of more than $3.6 million. The vaccine, Merck’s Gardasil, prevents infections from the sexually transmitted virus HPV, which can cause cervical cancer, genital lesions and genital warts. Gardasil was approved in June for girls as young as 9 and a government advisory panel later recommended that the vaccine be given before girls become sexually active. About 6 million Americans are diagnosed annually with HPV. The American Cancer Society estimates cervical cancer will be diagnosed in 9,700 women nationwide this year and that 3,700 will die. An estimated 70% of cervical cancer cases are caused by HPV. Lawmakers in Maryland and Virginia have also proposed bills similar to the West Virginia legislation. In December, New Hampshire health officials announced plans to offer Gardasil human vaccine free to all girls to help protect them against cervical cancer. The New Hampshire Vaccines for Children program is funded by the federal government and private insurers and offers “no-cost” immunizations to children through age 18. The program also pays to vaccinate children against other diseases, such as hepatitis A and B, polio and measles. A total of $4.8 million has been budgeted for the HPV vaccine for 2007.

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