Merck’s Controversial HPV Vaccine Spurs $100 Million Capital Investment in Virginia

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas). A growing number of states nationwide are following Texas Governor Rick Perry’s lead to make Merck’s (NYSE:MRK) (Whitehouse Station, New Jersey) cervical cancer vaccine, Gardasil, a required element of regular childhood immunization programs. The measures are facing strong opposition from those who feel the option of whether or not to take the drug should be left for parents to decide. Whether or not the mandatory state laws pass, Merck is in the midst of a two-phase expansion valued at nearly $100 million at the Elkton, Virginia plant to accommodate the anticipated heavy demand for the drug.

The current $57 million expansion follows a $40 million first phase that was completed last year at the plant), where a portion of the Gardasil production process will take place when construction is complete in 2009. A vaccine fermentation unit was constructed during the first phase and the current project will add a new building and install purification equipment essential to the production of the drug.

Three injections of Gardasil are given in the upper arm over six months to achieve immunity. Insurers may cover the vaccine in some cases, but the retail price may run as much as $150 per shot. The drug delivers immunity against several of the more dangerous strains of the human papillomavirus (HPV), a common, sexually transmitted family of microorganisms that in some people cause genital infections including genital warts in men and women. In rare cases the virus leads to cancer of the cervix. About 10,000 new cases are diagnosed annually in the United States.

Last year, Gardasil received FDA approval for sale and marketing to girls and women ages 9 to 26. The drug delivers the most protection when given to children before they become sexually active. While males carry the virus, it is apparently harmless in most cases. Ongoing studies by Merck are looking at the benefits of vaccinating boys and young men as well as women through middle age.

Merck’s Elkton facility, which is referred to as the “Stonewall” plant, employs more than 700. First opened in 1941, the site is one of seven Merck manufacturing plants in the continental United States.

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