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Sun Pharma, SPARC sign pact to commercialise seizures drug in the US

Sun Pharma, SPARC sign pact to commercialise seizures drug in the US

Sun Pharma, SPARC sign pact to commercialise seizures drug in the US
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By CNBCTV18.COMNov 9, 2022 2:36:12 PM IST (Updated)

The benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection is designed to minimise the risk of neonatal gasping syndrome, a life-threatening condition.

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Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Co. Ltd (SPARC) on Wednesday announced that the companies have entered into a license agreement for commercialisation of phenobarbital for injection in the United States.


SPARC had submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for this product in February 2022. The formulation, targeted at treating seizures in neonatal patients, is still awaiting the USFDA approval.

The benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection is designed to minimise the risk of neonatal gasping syndrome, a life-threatening condition. Currently, there are no phenobarbital injection products approved by the USFDA for the treatment of seizures in newborns.

As per the agreement signed by the two companies, Sun Pharma has agreed to 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.

Sun Pharma was also in focus this morning after the company's Mohali facility received an Official Action Indicated (OAI) status from the USFDA.
An OAI classification means that the USFDA may withhold approvals of any pending products until outstanding observations are resolved.

Shares of Sun Pharma Advanced Research Company are trading 0.4 percent lower after a brief spike at Rs 253.60.

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