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Merck Seeks FDA Priority Review for Cervical Cancer Vaccine
  Mon Dec 5, 2005 10:09 AM ET
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON (Reuters) - Merck & Co. Inc. (MRK.N: Quote, Profile, Research) said on Monday it had filed its experimental vaccine Gardasil for U.S. Food and Drug Administration approval, confirming its lead in the race to commercialize a shot against cervical cancer.
Merck and Sanofi Pasteur MSD (SASY.PA: Quote, Profile, Research), which will market the product in Europe, said applications for approval would also be submitted in Europe and Australia before the end of 2005, with filings in other countries following from early 2006.
Gardasil will compete with GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) Cervarix, which the British group plans to file for European approval in the first half of 2006. Glaxo has yet to set a date for U.S. filing but is expected to do so before the end of December.
Both vaccines have proved effective in clinical trials in preventing the most important strains of human papillomavirus (HPV), a sexually transmitted virus which causes most cases of cervical cancer, the second biggest cancer killer in women.
Merck is seeking a priority review from the FDA, which could mean Gardasil gets a green light within six months, instead of the normal 10 months or so.
Gardasil and Cervarix are among the most closely watched new products in both Merck and Glaxo's portfolios, reflecting the scale of the potential patient market they are addressing.
Merck estimates the target population for cervical cancer vaccines could total 75-80 million in the United States and Europe alone, while Glaxo believes the total market for may be worth $4 billion to $7 billion in annual sales by 2010.
The vaccines promise to be controversial, however, since they would be targeted largely at young girls. Both drug makers have been meeting with advocacy groups to dispel concerns that giving the shots might promote sexual activity.
While Merck is set to enjoy a first-mover advantage over Glaxo in the marketplace, industry analysts predict vaccination ramp-up will take several years, so the delay for Cervarix should still allow Glaxo to be competing in all markets by the end of the decade.
Both Gardsil and Cervarix prevent infections from HPV strains 16 and 18, which are responsible for 70 percent of cervical cancers. However, Merck's product also contains antigens against HPV types 6 and 11, which cause genital warts.
Each year 470,000 women around the world are diagnosed with cervical cancer. If it is detected and treated early, survival rates are good but if left it becomes a killer.
Eighty percent of deaths from the disease occur in developing countries, which could be an important market for vaccine manufacturers provided they can offer preferential prices in association with governments or charities.
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