Late-stage study data presented at the European Research Organization on Genital Infection and Neoplasia conference on Thursday suggest that, compared with placebo, Merck & Co.’s Gardasil prevented 90 percent of external genital lesions caused by human papillomavirus types 6, 11, 16 and 18 in boys and young men.

As part of the study, researchers randomly assigned 4065 males between the ages of 16 and 26 to receive three injections of either Gardasil or placebo over a six-month period. The results showed that after a mean duration of about 29 months, three cases of external genital lesions were observed among subjects vaccinated with Gardasil, compared with 31 cases in the placebo group. The vaccine was also found to be 86-percent effective at reducing persistent HPV infection, Merck indicated.

The drugmaker said that it is on schedule to submit an application to the FDA by the end of 2008 to market the product for the prevention of external genital lesions caused by the four HPV strains in boys and men aged 9 to 26 years. Lauri Markowitz, from the US Centers for Disease Control and Prevention, stated that the data are “obviously encouraging,” but noted that “policy makers will be looking at a variety of different issues,” including how cost effective the product would be if used in males.

Merrill Lynch’s David Risinger has estimated that if the product is approved for use in males, more than 350 000 boys and men could receive the injection next year, with the annual number increasing to over 1 million by 2011. The analyst forecast that Gardasil could achieve peak sales of $2.7 billion in 2011.

The vaccine is currently approved for use in females aged 9 through 26 years to prevent cervical, vulvar and vaginal cancers caused by HPV strains 16 and 18, and genital warts caused by HPV types 6 and 11. Merck is awaiting a decision by the US regulator to market the vaccine to women through age 45.

Source: FirstWord

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