Sun Pharma, SPARC collaborate for commercialization of phenobarbital for injection in US
SPARC's phenobarbital sodium powder for injection is a benzyl alcohol and propylene glycol-free formulation intended for the treatment of seizures in neonates.
Mumbai: Sun Pharma, including its subsidiaries, and Sun Pharma Advanced Research Company Ltd. (SPARC) have announced the signing of a licensing agreement for the commercialization of benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the United States.
SPARC submitted a New Drug Application (NDA) to the U.S. 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 US $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 specialty branded products in the U.S. 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 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," said Anil Raghavan, CEO, SPARC.
It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures. The currently marketed phenobarbital formulations are notified under the DESI (Drug Efficacy Study Implementation) program list by the U.S. Department of Health and Human Services.
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