Sun Pharma and Sun Pharma Advanced Research Company (SPARC) yesterday announced the signing of a licensing agreement for commercialisation of 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 (FDA) for this product for the treatment of neonatal seizures in February 2022. Currently, there are no phenobarbital injection products approved by the FDA for the treatment of seizures in newborns, a statement from Sun Pharma notified.
Under the terms of the licence agreement, Sun Pharma will pay SPARC an upfront payment of $10 million. 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, the statement said.