BackSun Pharma partners SPARC to market epilepsy drug in US
SPARC will give the licence of Elepsia XRTM to a Sun Pharma subsidiary for the US market and will receive an upfront payment of $10 million for it
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Hyderabad: Sun Pharmaceutical Industries Ltd on Monday said it has entered into a licensing agreement with Sun Pharma Advanced Research Co. Ltd (SPARC) for the latter’s epilepsy drug Elepsia XRTM for the US market.
SPARC is the research arm of Sun Pharma, India’s largest drug maker.
As per the agreement, SPARC will give the licence of Elepsia XRTM or levetiracetam extended-release tablets, as they are generically known, to a wholly-owned subsidiary of Sun Pharma for the US market and will receive an upfront payment of $10 million for it.
“It (SPARC) is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM," Sun Pharma said in a statement.
Elepsia XRTM was approved by the US Food and Drug Administration (USFDA) in March 2015. However, in September 2015, SPARC received a complete response letter (CRL) from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility at Halol site of Sun Pharma was not acceptable on the date of approval.
Sun Pharma has undertaken a detailed remediation at Halol for restoring current good manufacturing practices (cGMP) compliance status for the site.
“ELEPSIA XRTM is designed as a novel once-a-day formulation of Levetiracetam using SPARC’s proprietary Wrap Matrix technology. It is designed to reduce pill burden and help improve convenience and compliance in these patients," said Anil Raghavan, chief executive officer (CEO) of SPARC.
“If and when the USFDA re-approves the ELEPSIA XRTM application, Sun Pharma’s significant US presence will help SPARC in commercializing this important product for patients in the US market," Raghavan said. “The in-licensing of ELEPSIA XRTM will facilitate Sun Pharma’s anticipated entry into the proprietary CNS segment in the US," said Kirti Ganorkar, senior vice-president, business development, Sun Pharma.
“This is a part of Sun Pharma’s strategy to raise its presence in the US specialty segment through its newly created Sun Neurosciences business unit," Ganorkar said.
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