Merck & Co aims to expand Gardasil usage to boost flagging sales

US drug major Merck & Co recently submitted study data to the US Food and Drug Administration  related to the use of its cervical cancer vaccine Gardasil in women in the age group of 27-45 years. Gardasil was approved by the FDA approval in June 2006 for preventing cervical cancer and genital warts in females in the age group of 9-26 years.

However, comment analysts at Zacks Equity Research, Merck's vaccine segment has been witnessing pressure from lower turnover of Gardasil. While sales ramped very quickly following the approval in 2006, they have struggled recently due to difficulty in penetrating patients. Global sales of Gardasil declined 22% to $311 million during the third quarter. Although the vaccine received FDA approval in September 2009 for the protection of boys and men, within the age group of nine to 26 years, from genital warts related to human papillomavirus (HPV) types 6 and 11, sales will remain under pressure as, on the same day, UK drug giant GlaxoSmithKline's competitive cervical cancer vaccine, Cervarix, finally received approval in the USA (The Pharma Letter October 19, 2009).

Gardasil is designed to target four HPV strains; HPV 6, HPV 11, HPV 16 and HPV 18. While two of these (HPV 16, HPV 18) account for about 70% of cervical cancer cases in the USA, the other two HPV strains are responsible for genital warts in both men and women.