Sun Pharma, SPARC in pact for commercialisation of phenobarbital for injection in US
Sun Pharma will pay SPARC an upfront payment of $10 million
A wholly-owned subsidiary of Sun Pharmaceutical Industries 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 neonatal seizures 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 $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.
“SPARC’s benzyl alcohol and propylene glycol-free formulation of phenobarbital for injection is an exciting addition to our growing portfolio of speciality 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 the lives of patients,” said Abhay Gandhi, CEO, North America, Sun Pharma.
“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 minimise the risk of neo natal gasping syndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol-containing drug formulations,” said Anil Raghavan, CEO, SPARC.
