Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company Ltd (SPARC) have formalised a licensing agreement for the commercialisation of benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the United States. Sun Pharma will pay SPARC an upfront payment of $10 million.

SPARC had submitted a New Drug Application (NDA) to the US Food and Drug Administration (US FDA) for this product to treat neonatal seizures in February 2022. Currently, there are no phenobarbital injection products approved by the US FDA for seizures treatment in newborns, a note from the companies said.

SPARC will also be eligible to receive milestone payments on achievement of regulatory and sales , 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 US. Through our existing relationships with hospitals and other institutional customers, we are well-positioned to bring this product to market...,”said Abhay Gandhi, Sun Pharma’s Chief Executive (North America). The product is designed to minimise the risk of neonatal gasping syndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol containing drug formulations, explained Anil Raghavan, Chief Executive of SPARC.

Mohali plant under OAI

Meanwhile, Sun Pharma has provided a further update on the USFDA inspection at its Mohali (Punjab) facility from August 3 to 12, 2022 and the issuance of Form-483 by the regulator with six observations.

The plant has been put under the ‘Official Action Indicated’ (OAI) classification, Sun Pharma said, in a recent listing on the stock exchange.

The regulatory communication states, “the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved and may initiate additional actions, if any, under the current Consent Decree.” The company continues to manufacture and distribute existing products for the US market, thereby this is not likely to have any material adverse impact on current business from the facility, it added.

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