Merck receives FDA approval for Vaxneuvance vaccine

The 15-valent pneumococcal vaccine using Ligand’s CRM197 vaccine carrier protein

Merck has received approval from the FDA for Vaxneuvance also known as V114, for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. The 15-valent pneumococcal vaccine using Ligand’s CRM197 vaccine carrier protein, which is produced using the company’s Pelican Expression technology platform.

Under the terms of the licensing agreement with Merck, Ligand was paid a $2m milestone payment following the FDA approval and is entitled to a single-digit royalty on net product sales.

Merck plans to submit a supplemental regulatory licensure application with the FDA later this year for the use of Vaxneuvance in children.

“We are delighted to see Merck’s progress with Vaxneuvance along with the FDA approval of another Pelican Expression Technology-enabled medical advancement,” said John Higgins, CEO of Ligand. “We look forward to the launch of this important pneumococcal conjugate vaccine, and the continued development and progression of our multiple partnerships involving Pelican’s cost-effective and scalable production of our CRM197 vaccine carrier protein also known as PeliCRM.”

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Ligand (more information, website)

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