Mumbai: Drug major Sun Pharma on Wednesday said it has inked a licensing agreement with Sun Pharma Advanced Research Company to commercialise a medication for the treatment of neonatal seizures in the US market. The Mumbai-based drug maker has inked a pact with Sun Pharma Advanced Research Company (SPARC) to commercialise benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the US.
SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for the said product in February 2022.
Currently, there are no phenobarbital injection products approved by the US FDA for the treatment of seizures in newborns.
Under the terms of the license agreement, Sun Pharma will pay SPARC an upfront payment of USD 10 million, the drug major said in a statement.
SPARC will also be eligible to receive milestone payments contingent upon the achievement of regulatory and sales milestones, as well as tiered royalties on sales, it added.
“Through our existing relationships with hospitals and other institutional customers, we are well-positioned to bring this product to market and make a difference in the lives of patients,” Sun Pharma North America CEO Abhay Gandhi said.
SPARC CEO Anil Raghavan said the medication is designed to minimise the risk of neonatal gasping syndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol containing drug formulations.
SPARC was formed in 2007 through a demerger from Sun Pharma.