Merck (MRK) recently received U.S. Food and Drug Administration (FDA) approval for the use of its vaccine, Gardasil, for the protection of boys and men aged 9–26 years from genital warts related to human papillomavirus (HPV) types 6 and 11. Originally, Gardasil was approved by the FDA in June 2006, as the first vaccine for cervical cancer, (caused by HPV) for females between 9 to 26 years of age.
Earlier, in September, Gardasil received favorable recommendation from the FDA’s advisory panel. The panel voted 7-1 in favor of the vaccine’s safety and 7-0 (with one abstention) regarding its effectiveness. Apart from the favorable recommendation, the panel members expressed their concern about the lack of long-term data, which would have showed the timeframe of effectiveness of the vaccine.
The final approval of the vaccine follows the results of Merck’s phase III studies of Gardasil conducted over a period of three years on more than 4,000 males aged 16 to 26 years. The vaccine was found to be effective in 90.4% of the cases.
It is estimated that about one million people in the US are likely to develop genital warts this year. While some resolve without treatment; warts recur in at least 25% of the cases that require treatment.
In order to increase the vaccine’s affordability, Merck plans to implement various patient rebate programs to support eligible privately insured males with partial or no coverage for the vaccine. An advisory committee on Immunization Practices is likely to decide shortly whether to recommend Gardasil for use in males, as well as public funding through the U.S. Centers for Disease Control and Prevention (CDC) contract.

In another development, Merck’s primary competitor in the field of cervical cancer vaccine, GlaxoSmithKline (GSK) received an FDA approval for Cervarix. This will undoubtedly hamper US sales of Gardasil which is already struggling due to difficulty in catering to older patients. Gardasil sales fell 5% in 2008 and were down 18% in the second quarter of 2009. Broader use of Gardasil would enable Merck to improve upon the slower sales of the product.

We have a Neutral recommendation on Merck.

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