Mumbai-based Sun Pharma, including its subsidiaries, and Sun Pharma Advanced Research Company (SPARC) on Wednesday 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 (US FDA) for this product for the treatment of seizures in newborns in February 2022, according to Sun Pharma’s statement shared with stock exchanges.
Sun Pharma is a wholly-owned subsidiary of Sun Pharmaceutical Industries. Currently, there are no phenobarbital injection products approved by the US FDA for the treatment of seizures in newborns.
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 and tiered royalties on sales.
“SPARC’s benzyl alcohol and propylene glycol-free formulation of phenobarbital for injection is an exciting addition to our growing portfolio of specialty branded products in the US. 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 patients’ lives,” said Abhay Gandhi, CEO North America, Sun Pharma.
SPARC CEO Anil Raghavan said, “SPARC is excited to enter into this collaboration with Sun Pharma and is committed to developing new products to address the needs of patients. SPARC’s benzyl alcohol and propylene glycol-free formulation of phenobarbital for injection is designed to minimize the risk of the neonatal gasping syndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol-containing drug formulations.”