Benzinga | Jul 19, 2021 08:07AM EDT

Ligand's Partner Merck Receives FDA Approval for VAXNEUVANCE For The Prevention of Invasive Pneumococcal Disease in Adults Caused by 15 Serotypes; Under The Terms Of The Licensing Agreement With Merck, Ligand Earned A $2M Milestone Payment

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced that its partner Merck has received approval from the U.S. Food and Drug Administration (FDA) for VAXNEUVANCETM, 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. VAXNEUVANCE is a 15-valent pneumococcal vaccine utilizing Ligand's CRM197 vaccine carrier protein, which is produced using the patent-protected Pelican Expression Technology(tm) platform.

Under the terms of the licensing agreement with Merck, Ligand earned a $2 million milestone payment upon FDA approval of VAXNEUVANCE and is entitled to a low-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(tm)."