Merck's experimental human papilloma virus (HPV) vaccine Gardasil, for prevention of cervical cancer, could prove a blockbuster many times over and salve the company's damaged reputation.
Deutsche Bank's Barbara Ryan said that if Merck can beat GlaxoSmithKline to the punch and wrangle an endorsement from the Centers for Disease Control, ensuring widespread uptake among young women, Gardasil could generate $1-$5 billion and save tens of thousands of lives. "If Merck launched first with a universal recommendation, it certainly could be a multibillion dollar drug," said Ryan. "It would improve the fundamentals of their business, but whether a lot of the benefits would get gobbled up by Vioxx litigation, it's just too early to say."
GSK also has an HPV vaccine in development, and has published studies showing that it prevents persistent infection with HPV types 16 and 18, which cause 70 percent of cervical cancers. The drug, Cervarix, is in Phase III trials and GSK plans to file for European approval in early 2006, but has not set a filing date for the U.S. Merck this week announced Phase III trial results showing its vaccine 100 percent effective in preventing HPV 16 and 18 infections. Gardasil also reduces infections with HPV 6 and 11, responsible for 90 percent of genital warts.
The company vowed to file for approval of the vaccine by year's end, and expects to see it approved sometime in 2006.
Cervical cancer caused 3,000 deaths in the U.S. last year, and an estimated 300,000 worldwide. Merck's ongoing FUTURE II trial involves 25,000 people in 33 countries worldwide. Women cited in the results were followed for two years.