Pharma Focus Asia

Sun Pharma and SPARC enter into a license agreement for commercialization of phenobarbital for injection in the US

Thursday, November 10, 2022

A wholly-owned subsidiary of Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd., announced the signing of a licensing agreement for 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 neonatal gasping yndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol containing drug formulations,” said Anil Raghavan, CEO, SPARC.

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