NEW YORK - Merck & Co. said the Food and Drug Administration will decide within six months whether to approve the cervical cancer vaccine Gardasil for women ages 27 to 45.
The agency is cutting its review time of Gardasil by four months, the company said yesterday. Gardasil is already approved for girls and women ages 9 to 26 and is one of Merck's top-selling products with $1.5 billion in sales last year.
The vaccine protects against the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer later in life. Use among older women may generate an additional $1 billion in annual sales from Gardasil as the drug competes with Cervarix, a similar vaccine developed by London-based GlaxoSmithKline PLC that is awaiting FDA approval, said Bear Stearns & Co. drug analyst John Boris in New York.
Merck is counting on Gardasil to replace revenue lost from products losing patent protection and facing cheaper generic competition in the next three years, including the osteoporosis drug Fosamax and blood pressure drug Cozaar, which generated a combined $6.3 billion last year. Glaxo's Cervarix, which may gain US approval early next year, has been shown effective in women ages 10 to 55.
Merck, based in Whitehouse Station, N.J., fell 20 cents in New York Stock Exchange composite trading.
Gardasil prevented 91 percent of cases of precancers and external genital lesions in women aged 24 to 45, a company-sponsored study found. Merck's vaccine may benefit older women because many still aren't infected with cancer-causing strains of the virus later in life and have sex with multiple partners, said Richard Haupt, Merck's medical director for global vaccines and infectious disease, in a November interview.
If the vaccine is approved for that group, 34 percent of women ages 27 to 35 in the United States may be vaccinated by 2012 and 12 percent of US women ages 36 to 45, Boris, of Bear Stearns, wrote in an Oct. 23 research report.
Gardasil protects against the HPV strains 16 and 18, which are responsible for 70 percent of cervical cancers and HPV strains 6 and 11, which cause 90 percent of genital warts. Cervical cancer kills 250,000 women a year, according to the World Health Organization, which is based in Geneva.