Sanofi Pasteur MSD has filed for approval of its cervical cancer vaccine Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) in Europe, just a few days after partner Merck & Co submitted the product in the USA.
The submissions put the two companies ahead of rival GlaxoSmithKline in the race to bring this type of product to market. GSK is developing its own cervical cancer vaccine, Cervarix, which is due to be submitted for approval in Europe in the first half of 2006, followed by filings in other markets over the remainder of the year.
Phase III trials reported a few weeks ago showed that Gardasil was 100% effective in the study in preventing the development of pre-cancerous cervical lesions that can develop into full-blown cervical cancer. Analysts have suggested that the market for an effective cervical cancer prophylactic cancer vaccine could be upwards of $4 billion dollars a year.
Both Gardasil and Cervarix are designed to protect against two forms of the human papillomavirus, types 16 and 18, which are spread by sexual contact. Together these two forms of HPV are responsible for 70% of all cervical cancers. Gardasil also has antigens against HPV types 6 and 11, which account for an estimated 90% of genital wart cases.
Merck is seeking a priority review from the US Food and Drug Administration (FDA), so Gardasil could get the nod within six months, rather than 10. Cervical cancer kills 274,000 women worldwide every year, including 33,000 in Europe. If treated early five-year survival rates can be as high as 80%-90%, but they plummet to 14% if the cancer remains untreated and spreads.
Gardasil is one of three late-stage vaccines in development at Merck and Sanofi Pasteur MSD. In April, Merck filed in the USA for approval of Rotateq, a vaccine for the prevention of paediatric rotavirus gastroenteritis, and Zostavax for the prevention of shingles and associated pain. Sanofi Pasteur MSD submitted European applications for Rotateq and Zostavax in April and May 2005, respectively.