Merck has submitted its cervical cancer vaccine Gardasil to the FDA following impressive clinical trial results against the two most common causes of the cancer.

Gardasil targets 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 assessing Gardasil's use in women against HPV types 16 and 18, the cause of 70% of all cervical cancer cases, found the vaccine prevented 100% of cervical pre-cancers and non-invasive cervical cancers.

If approved the vaccine would need to be given before the onset of sexual activity, but it could then remove the necessity of cervical smear tests.

For fuller protection men too would need to be vaccinated and trials of Gardasil in adolescent males and females produced higher anti-HPV immune responses in that group than in young women, according to results released in May.

Merck wants a priority review from US regulator the FDA for Gardasil's biologics licence which, if granted, would cut review time from ten to six months.

Speed of review is important for Merck because Gardasil will soon face competition from GlaxoSmithKline's Cervarix, a similar vaccine that is due to be filed with regulators next year.

Cervarix has also 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.

For its vaccine Merck has enrolled more than 25,000 people in the phase III clinical trial programme.

The product will be marketed by Sanofi Pasteur MSD in Europe, where the company, a joint venture between Merck and Sanofi-Aventis' vaccine arm, plans to submit it to the regulatory authorities before the end of this year.

Merck and Sanofi Pasteur MSD have two other late-stage vaccines in development: Rotateq, a vaccine for paediatric rotavirus gastroenteritis, and Zostavax, a vaccine for shingles and its associated pain. EMEA marketing applications were submitted in April (Rotateq) and May (Zostavax) this year.

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Tuesday , November 01, 2005

pharmafocus@wiley.co.uk