US drug major Merck & Co has filed a Biologics License Application for its cervical cancer vaccine Gardasil (quarivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) with the US Food and Drug Administration, raising hopes that the vaccine could be on the market in the second half of next year, should a priority review be granted.
Gardasil has been the subject of much media hype since trials showed it to be 100% effective against the four most common types of human papillomavirus, which can spur development of cervical cancer. In fact, according to the company, the link between HPV and cervical cancer is stronger than that between smoking and lung cancer.
The group’s European partner, Sanofi Pasteur, the vaccines unit of French drug giant Sanofi-Aventis, is planning to file a similar application with the European Medicines Agency before the end of the year, and Merck says it intends to complete a submission to the Australian regulatory authorities this month, with applications in other countries starting early next year.
Cervical cancer is the second most common cause of death from cancer (after breast cancer) amongst young women in Europe, with around 3,500 new cases and 15,000 deaths each year. Analysts have suggested that the market for an effective HPV vaccine would be worth upwards of $4 billion dollars a year, although it remains to be seen which of the front-line candidates will garner the greatest share. The companies’ main rival is UK drug giant GlaxoSmithKline, which said earlier this year it plans to file its HPV vaccine Cervarix in Europe during the first half of 2006, and in international markets over the remainder of the year.