Merck in race to bring first cervical cancer vaccine to market
pharmafile | January 18, 2006 | News story | Sales and Marketing |
Merck and GlaxoSmithKline are head-to-head in a race to establish a market for their rival cervical cancer vaccines, both set for approval in 2006.
The most advanced of the two is Merck's Gardasil, which has been submitted to the FDA following impressive clinical trial results against the two most common causes of the cancer.
Merck is looking to widen the use of its vaccine from industrialised nations to the developing world, where nearly 80% of cervical cancer cases occur, with clinical trials in India.
The company says that by collaborating with the Indian Council of Medical Research it hopes to establish a model for introducing Gardasil that can be exported to other developing countries.
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.
GlaxoSmithKline's 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 GSK is highlighting clinical data on Cervarix's use in young girls, potentially the most lucrative patient population for a cervical cancer vaccine.
A European phase III trial of more than 650 girls and women found the antibody levels induced by Cervarix against HPV 16/18 were at least two times as high in 10-14 year old adolescent girls than in women aged 15-25 years old.
Higher antibody levels in the 10-14 age group means those in it may be protected against cervical cancer for longer than those aged 15-25.
Improved efficacy at a younger age is important because any cervical vaccine will need to be given before the onset of sexual activity, but it could then remove the necessity of cervical smear tests.
Cervarix is due to be filed with regulators this year and with speed of review crucial Merck is pressing the FDA to grant Gardasil a priority review.
Gardasil will be marketed by Sanofi Pasteur MSD in Europe, where the company, a joint venture between Merck and Sanofi-Aventis' vaccine arm, submitted it to regulatory authorities in December.
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