Merck, Sanofi JV wins anal cancer indication for Gardasil in EU

Merck's Gardasil HPV vaccine--FierceBiotech file photo

Gardasil may be the No. 2-selling vaccine in the world, but its marketers have struggled against a variety of barriers to get it where they want it in terms of uptake. Now, a new anal cancer indication in Europe may help with that goal.

On Wednesday, Sanofi Pasteur MSD--the European joint venture between Sanofi ($SNY) and Merck ($MRK)--announced that the European Commission had green-lighted Gardasil in both males and females for the prevention of anal cancers and precancerous lesions related to certain HPV types. According to the company, about 6,800 new cases of anal cancer occur each year in Europe, of which between 75% and 80% are attributable to HPV types that Gardasil targets.

"Thanks to the new indication for anal cancer, Gardasil provides today a unique prevention tool for such a serious oncological disease," Sanofi Pasteur MSD President Dr. Jean-Paul Kress said in a statement.

The new use could also help improve the case for covering the vaccine for both sexes in Europe; unlike Australia, whose National HPV Vaccination Program provides Gardasil free for both girls and boys, the U.K., for one, only covers the vaccine for girls aged 12 to 13.

Sanofi Pasteur MSD President Dr. Jean-Paul Kress

"The possibility to prevent anal cancer further reinforces the need for widespread vaccination of both males and females against HPV, especially since there are currently no other routine measures or screening programs available for prevention of anal cancers," Kress said.

A new, two-dose schedule could help to that end as well. Given the nod in April by the EC, the regimen will cut the number of doses per patient by one, with some suggesting the country use the money saved to extend its Gardasil program to boys.

Merck and Sanofi, too, are optimistic that such a switch would actually improve sales despite limiting per-patient shots, with a Sanofi Pasteur MSD spokeswoman recently telling British magazine GP that the move "could help to extend HPV vaccine coverage and increase uptake."

- read the release

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