Merck's human papilloma virus vaccine Gardasil has reached blockbuster status in its first year on the market, the company reported Oct. 22 during its third quarter earnings call.

"Year-to-date revenue exceeds $1.1 billion," Merck CEO Dick Clark told analysts during the call. Revenues for Gardasil in the third quarter were $418 million.

"Merck has distributed more than 13 million doses of the vaccine worldwide since it came to market in June of 2006," Clark noted.

Gardasil was approved last year for vaccination of women and girls ages 9 to 26 to prevent cervical cancer, cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers caused by HPV types 16 and 18, as well as genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18 (¹ Also see "Merck’s Gardasil HPV Vaccine Clears FDA" - Pink Sheet, 8 June, 2006.).

Growth has come from the approved population overall, but certain demographics in particular have begun to pick up, the firm said.

"With regard to the age range that is currently indicated, we've begun to see a little more use in the 12 through 18-year-old range" due to the company's efforts to target college-age women more, Investor Relations Director Graeme Bell noted.

Merck is seeking to expand its indications for the vaccine on several fronts. The firm filed an sBLA for protection against vaginal and vulvar cancers earlier this year (² Also see "Merck Seeks Additional Claims For Gardasil" - Pink Sheet, 17 April, 2007.).

In addition, the company is conducting studies to evaluate Gardasil in women up to the age of 45 and 16- to 26-year-old men.

"Based on data available at this time, a presentation of the mid-adult women data are expected this quarter," Clark said.

The company also will continue to support Gardasil with direct-to-consumer ads in the fourth quarter, according to Merck.

The firm launched the first national Gardasil-specific DTC campaign last fall, featuring a marketing message designed to empower teens and young women to become "one less" woman who will battle cervical cancer (³ Also see "Merck Launches "One Less" Gardasil DTC Ads Targeting Teens" - Pink Sheet, 13 November, 2006.).

Merck has moved quickly to commercialize its HIV/AIDS treatment Isentress (raltegravir) following FDA approval Oct. 12, the company pointed out (⁴ Also see "Isentress Approval Carries Limited Indication" - Pink Sheet, 12 October, 2007.).

"Within two days [of approval] we began packaging and shipping product to our distribution centers," Clark noted. "Within three days we began to process and ship initial customer orders. The first business day after approval, our fully trained specialty representatives ran doctors offices [reporting] on Isentress. And as of today the first prescription has been filled."

-Brooke McManus (b.mcmanus@elsevier.com)

Gardasil Gains Blockbuster Status In Its First Year On The Market

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