FX.co ★ Ligand Says Merck Receives FDA Approval For CAPVAXIVE For Adults

Ligand Pharmaceuticals Inc. (LGND) announced on Tuesday that its partner Merck & Co., Inc. (MRK), also known as MSD outside the U.S. and Canada, has secured approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE. Previously identified as V116, this 21-valent pneumococcal conjugate vaccine is intended for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

The approval for the pneumococcal pneumonia indication was granted under an accelerated approval process. As a result of the FDA's approval, Ligand will receive a $2 million milestone payment, and the company will also earn royalties on global net sales.

CAPVAXIVE incorporates the PeliCRM197 carrier protein, which enhances the immunogenicity of antigens in conjugate vaccines. This carrier protein is produced using the Pfenex Expression Technology platform initially acquired by Ligand in 2020, and subsequently spun off to Primrose Bio in September 2023.

Through the Primrose Bio transaction, Ligand retained commercial royalty rights associated with the Pfenex Expression Technology, including those related to CAPVAXIVE.

With this arrangement, Ligand is now positioned to collect commercial royalties on six products developed using the Pfenex Expression Technology, which includes Merck's CAPVAXIVE and VAXNEUVANCE.