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The European Medicines Agency (EMA) accepted Pfizer’s ($PFE) application to expand its label for blockbuster vaccinePrevenar 13 back in August, and so far, an advisory committee likes what it sees.
Europe’s Committee for Medicinal Products for Human Use (CHMP) has backed Prevenar, recommending the European Commission (EC) expand the vaccine’s label in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains. And if the EC follows suit, the indication will apply to all EU member states plus Iceland, Lichtenstein and Norway.
Pfizer based its application on its CAPiTA trial, which showed that Prevenar slashed first episodes of community-acquired pneumonia (CAP) by 46% and first episodes of non-invasive CAP by 45%. Those numbers impressed analysts such as BMO Capital Markets’ Alex Arfaei, who has predicted strong adult uptake outside the U.S. where smoking and other factors make populations more vulnerable to pneumococcal disease.
If Pfizer does win the EC’s blessing, it’ll just be another notch in Prevenar’s belt. The shot is the best-selling vaccine in the world, hauling in $4.05 billion in 2013 global sales–nearly twice as much as No. 2 Gardasil from Merck ($MRK). And last August, Pfizer won a key CDC panel endorsement for universal use of the jab in adults over the age of 65–a nod analysts say could add $2 billion in peak sales potential.
But in the meantime, Pfizer’s been working to expand its lineup beyond its best-selling franchise, too. Shortly after closing a deal to acquire Baxter’s marketed vaccine portfolio, it struck a pact earlier this month to acquire Switzerland’s RedVax for an undisclosed sum.
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| Pfizer R&D chief Mikael Dolsten |
And not all of that expansion will come through deals: At last week’s JP Morgan Healthcare Conference, company R&D chief Mikael Dolsten said the pharma giant would start up a “pivotal” Phase IIb study of its Staphylococcus aureus candidate in the middle of this year. If all goes well, “we believe there are opportunities to go to dialogues around an accelerated approval” based on the study, he said.