Pharmaceutical giant Sun Pharma said on Wednesday it had signed a licensing deal with Sun Pharma Advanced Research Company to commercialise a drug for neonatal epilepsy in the US market.
The Mumbai-based drugmaker has signed an agreement with Sun Pharma Advanced Research Company (SPARC) to commercialise sodium phenobarbital powder with benzyl alcohol and propylene glycol in the United States.
SPARC submitted a New Drug Application (NDA) for this product to the US Food and Drug Administration (USFDA) in February 2022. Currently, there is no FDA-approved phenobarbital injection product for the treatment of neonatal seizures.
Under the terms of the license agreement, Sun Pharma will pay SPARC an upfront payment of $10 million, the pharma giant said in a statement. It added that SPARC will also be eligible to receive milestone payments based on the achievement of regulatory and sales milestones, as well as tiered royalties on sales.
SPARC CEO Anil Raghavan said the drug was designed to minimise the risk of neonatal wheezing syndrome, a life-threatening condition that can be observed with the use of benzyl alcohol-containing pharmaceutical preparations. SPARC was demerged from Sun Pharma in 2007.