Many Wall Street analysts greeted the FDA's decision to reject Merck's bid to expand the use of Gardasil to 27 to 45-year-old women with a yawn. Most analysts think the key market for the vaccine is already covered by the agency's 2006 approval of the cervical cancer vaccine to protect girls and women aged 9 to 26. The older group was unlikely to deliver any significant new revenue. And Gardasil has captured a significantly larger market than GlaxoSmithKline's Cervarix.
One of the few dissents to that opinion came from James Kelly, an analyst at Goldman Sachs who said the new market is important to Merck because sales of Gardasil are beginning to peak. Merck says it plans to respond to the FDA's decision in about a month.
- read the AP report