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Merck Receives FDA Approval for CAPVAXIVE

CAPVAXIVE is a vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Merck & Co., known as MSD outside the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE, previously known as V116, a 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. The indication for pneumococcal pneumonia is under accelerated approval.
 
The FDA approval of CAPVAXIVE triggers a $2 million milestone payment to Merck’s collaborator Ligand and the company is entitled to a royalty on worldwide net sales.
 
“We are excited to see our longstanding collaborator Merck receive regulatory approval for CAPVAXIVE,” said Todd Davis, CEO of Ligand. “We believe this asset will be an important contributor to our portfolio, which includes more than 25 commercial products including two marketed by Merck.”

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