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First cervical cancer vaccine close to European approval

Published on 01/08/06 at 10:42am

The first-ever cervical cancer vaccine is set for approval in Europe following its recommendation from a key advisory committee.

The positive opinion for Merck's Gardasil from the Committee for Medicinal Products for Human Use places the company one step ahead of GlaxoSmithKline in its race to be the first to launch a cervical cancer vaccine.

Merck is seeking a European licence for Gardasil to immunise children, adolescents and adult women aged between nine and 26 years against cervical cancer.

Gardasil was recommended for the four types of the human papillomavirus (HPV) that cause the most cases of cervical cancer;  precancerous cervical lesions and external genital lesions, types 6, 11, 16 and 18.

Phase III clinical trials looking at the vaccine's use in women for HPV types 16 and 18 - the cause of 70% of all cervical cancers - found it had a 100% success rate in preventing the development of cervical pre-cancers and non-invasive cervical cancers.

In Europe, Gardasil will be marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis' vaccine branch. In central and eastern Europe, Gardasil will be marketed by Merck Sharp & Dohme alone under the brand name Silgard.

The vaccine received US approval in June this year and is now also available in Mexico, Australia, Canada and New Zealand. Merck is also in partnership with the Indian Council of Medical Research to develop the vaccine in the Third World.

Hot on Gardasil's heels is GSK's Cervarix, which was submitted to the EMEA in March this year and it is due to be sent to US regulators before the end of 2006.

Cervarix has been shown to protect against HPV types 16 and 18 and may provide additional protection against types 31, 45 and 52 - the cause of a further 12% of cervical cancers.

A European phase III trial of more than 650 girls and women found the antibody levels induced by Cervarix against HPV 16 and 18 were at least twice as high in 10-14 year old adolescents than in women aged between 15 and 25.

Higher antibody levels in the 10-14 year old age group means girls may be protected against cervical cancer for longer than those aged 15-25.

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