Sun Pharma Advanced Research Company (SPARC) and its parent Sun Pharma have entered into a licensing arrangement for its Elepsia tablets, used in the treatment of epilepsy, in the US market for an up-front payment of USD 10 million.
“As per the agreement, SPARC will license Elepsia XRTM (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of USD 10 million from Sun Pharma,” SPARC said in a BSE filing.
It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of Elepsia XRTM, the company added.
Elepsia XRTM was approved by the USFDA in March 2015. However, in September, 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 of Sun Pharma was not acceptable on the date of approval.
“The licensing of Elepsia XRTM is a step ahead in our desire to make it available for thousands of epilepsy patients taking multiple pills of Levetiracetam every day…If and when the USFDA reapproves the epilepsy XRTM application,
Sun Pharma’s significant US presence will help SPARC in commercialising this important product for patients in the US market,” SPARC CEO Anil Raghavan said.
Shares of SPARC were trading 5.11 per cent higher at Rs 367.50 apiece on BSE.