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FDA to Review Merck's New HPV Vaccine

Merck (NYSE: MRK  ) announced today that the Food and Drug Administration has accepted a marketing application for V503, its new vaccine against human papillomavirus, or HPV.

The pharmaceutical giant currently sells Gardasil, which protects against four types of HPV. GlaxoSmithKline (NYSE: GSK  ) also sells an HPV vaccine, Cervarix, but it only guards against two types of HPV. 

Covering more types of the virus has helped sales. Last year, Merck sold $1.8 billion worth of Gardasil worldwide. Sales of Cervarix by GlaxoSmithKline were only $270 million. 

V503 is designed to protect against nine different types of the virus. In a clinical trial presented at the European Research Organisation on Genital Infection and Neoplasia, V503 protected against 97% of the pre-cancers caused by the five additional viruses that V503 covers. For the four types of HPV that are covered by both V503 and Gardasil, the two vaccines produced equivalent levels of antibodies to the viruses, suggesting V503 works just as well for those virus types.

The increased coverage may not result in increased prescriptions since the CDC already recommends that all preteens get the current vaccines, but V503 could take some additional sales from GalxoSmithKline. Merck may also be able to justify a price increase over Gardasil because of the decrease in potential cancers.

V503 will receive a standard review, so Merck should receive an approval decision within a year of when the company submitted its application to the agency.


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Brian Orelli

Dr. Orelli is a Senior Biotech Specialist. He has written about biotech, pharmaceutical, and medical device companies for The Motley Fool since 2007.

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