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Quantum leap

Pharma companies are limbering up in the race to market the first cervical cancer vaccine after trial results for Gardasil reveal that the drug is extremely effective

Possibilities of a new lucrative, life-saving market for oncology vaccines have been substantially boosted after an eagerly anticipated experimental treatment has shown positive results in preventing the onset of cervical cancer.

Results published on October 6 suggest that the vaccine, Gardasil, administered in three doses over six months was 100 per cent successful at protecting against two types of human papilloma virus (HPV), which are present in 70 per cent of cervical cancers. The vaccine is also said to protect against genital warts, however the results of this part of the trial have yet to be published.

In the Gardasil phase III study, entitled Future II, none of the women given the vaccine developed cell changes that lead to cancer or pre-cancer - 22 women given dummy injections did. None of the women had HPV when they were initially enrolled. The tests indicate that Gardasil is not a cure for cancer but can prevent it from developing.

Sanofi Pasteur MSD and Merck, which developed Gardasil, plan to apply for a US Food and Drug Administration approval to market the vaccine before the end of the year. Licence application to the European Medicines Agency will inevitably follow.

Gardasil's creators are now in a race with GlaxoSmithKline (GSK), which is developing a similar vaccine called Cervarix. Results of the GSK trials have not yet been published, but if successful, will introduce fierce competition in the new oncology vaccine market, estimated to be worth $1.5bn a year.

Doctors have already begun calling for Gardasil to be part of a national health programme and given to boys and girls between the ages of nine and 11 before they become sexually active. Such a move may cause controversy but talks have already begun with various agencies, including the Department of Health.

Gardasil's progress is welcome news for Merck, which has suffered in the last three years - the patent on its biggest seller, Zocor, expires next year and it faces legal liabilities following the withdrawal of Vioxx.

Every day 40 women die of cervical cancer in Europe. It is the second most common cause of death from cancer (after breast cancer) in young women (15-44 years).

30th September 2008

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