Ligand Says Merck Receives FDA Approval For CAPVAXIVE For Adults

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) announced Tuesday that its collaborator Merck & Co., Inc. (MRK), known as MSD outside the U.S. 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 Ligand and the company is entitled to a royalty on worldwide net sales.

CAPVAXIVE utilizes the PeliCRM197 carrier protein which helps enhance antigen immunogenicity in conjugate vaccines. PeliCRM197 is produced using the Pfenex Expression Technology platform which Ligand initially acquired in 2020 and ultimately spun out to Primrose Bio in September 2023.

As part of the Primrose Bio transaction, Ligand retained the existing commercial royalties related to the Pfenex Expression Technology including CAPVAXIVE.

Ligand will now collect commercial royalties on six products developed with the Pfenex Expression Technology, including Merck's CAPVAXIVE and VAXNEUVANCE.