EUROPEAN COMMISSION APPROVES MERCK'S GARDASIL

European authorities have approved Merck's Gardasil, a vaccine that prevents cervical cancer and other potentially cancerous lesions caused by various strains of the human papillomavirus (HPV). Merck can now market the vaccine in all 25 member countries of the European Union (EU).

Sanofi pasteur will market the drug for Merck in 19 European countries, including 15 EU members, Merck said Sept. 22. In other Central and Eastern European countries, Merck will market the drug itself as either Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) or Silgard.

The European Commission has approved Gardasil for use in 9- to 26-year-old females to prevent cervical cancer, precancers and external genital warts caused by HPV types 6,11,16 and 18. Merck received U.S. approval for the vaccine earlier this year.

HPV types 16 and 18 account for 70 percent of cervical cancers. Nearly half-a-million women develop cervical cancer every year and more than half of them die as a result, according to the World Health Organization. Clinical trials Merck released in October 2005 showed Gardasil prevented virtually 100 percent of HPV-caused growths that can lead to the deadly disease. Cervical cancer kills approximately 15,000 women in Europe each year, according to Merck.

Gardasil is already approved in Australia, Brazil, Canada, Mexico and two African nations, according to the company.