Sanofi, Merck win EMA nod for Gardasil 9

Merck's ($MRK) new-and-improved Gardasil is making headway in Europe with the word late last week that the European Medicines Agency (EMA) has recommended the jab against 9 types of human papillomavirus (HPV) and will send its blessing to the European Commission.

Gardasil 9 was recommended by the EMA for routine vaccination 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. The vaccine, sold by Merck in the U.S. and Sanofi Pasteur MSD in Europe, immunizes against the most HPV types of any available vaccine, Sanofi Pasteur said in its release.

"We anticipate that, if approved, Gardasil 9 will represent a major step forward in HPV prevention. Gardasil 9 has the potential to help prevent over 80% of genital cancers caused by HPV and to reduce the transmission of the 9 HPV types," Dr. Jean-Paul Kress, president of Sanofi Pasteur MSD, said in a statement.

The EMA based its decision on four main studies testing the vaccine's efficacy against all 9 HPV types; safety was evaluated in more than 23,000 people.

The recommendation will be sent to the European Commission to decide on EU-wide marketing authorization. With European Commission approval, pricing and reimbursement negotiations can take place with member nations.

The FDA approved the jab in December 2014, and now with the CDC's Advisory Committee on Immunization Practices' blessing in February, Gardasil 9 can be used on a large scale against HPV in the U.S.

Such advancements are likely welcome news to Merck and Sanofi Pasteur. As of the FDA's approval, analysts expected the jab to bring in peak sales of $1.9 billion per year, though that will come at the expense of its predecessor. Leerink Partners analysts have estimated that sales of the old vaccine will sink to just $525 million in 2018 after reaching $1.83 billion in 2013; at one time, forecasts for Gardasil went as high as $10 billion, but sex-related stigma and other factors dampened those sales hopes.

- here's the EMA release
- and the Sanofi Pasteur MSD statement

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