Merck, Sanofi granted European Commission thumbs-up on Gardasil 9

Following behind a blockbuster is no easy task, but with a European Commission decision on Wednesday in favor of the vaccine, Merck's Gardasil 9 may just be up to the challenge of succeeding Gardasil.

The commission gave Merck ($MRK) and Sanofi Pasteur the go-ahead to market the 9-valent HPV jab in member nations, allowing the companies to engage in pricing and reimbursement negotiations with countries individually.

Gardasil 9 protects against HPV types 31, 33, 45, 52 and 58--which cause nearly 20% of cases of cervical cancer--as well as types 6, 11, 16 and 18, which the original Gardasil blocked. Analysts anticipate that it will reach $1.9 billion in annual sales--with much of that coming at the expense of its predecessor, predicted to fall in sales to $525 million by 2018 from $1.8 billion in 2013. 

Wednesday's nod follows a March recommendation by the European Medicines Agency based on 7 efficacy trials in more than 15,000 people in 30 countries. In a statement, Sanofi Pasteur MSD President Dr. Jean-Paul Kress called Gardasil 9 a "significant step forward for public health," adding that it can help prevent 90% of cervical cancers and help to prevent other associated cancers for which there is no current systematic screening.

Sanofi Pasteur MSD President Dr. Jean-Paul Kress

"We are delighted to receive the EU Commission approval for this important vaccine that provides an extraordinary opportunity to further prevent cancer in women and men throughout Europe," he said.

The vaccine won the FDA's favor last December and in February snagged the CDC's Advisory Committee on Immunization Practices' blessing, enabling it to be used on a large scale against HPV in the U.S.

Developed by Merck as a successor to Gardasil, the vaccine will be sold in Western European countries by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi Pasteur. Merck will sell it in the U.S., Canada and in other countries, including in Eastern Europe.

- here's the release

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