Sun Pharma Advanced Research Company (SPARC) and Sun Pharmaceutical Industries (including its subsidiaries or associate companies) have entered into a licensing arrangement for SPARC’s ELEPSIA XR (Levetiracetam Extended Release tablets).
As per the agreement, SPARC will license ELEPSIA XR (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of $10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XR.
ELEPSIA XR was approved by the 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 viz., Halol site of Sun Pharma was not acceptable on the date of approval. Sun Pharma has undertaken a detailed remediation at Halol for restoring cGMP compliance status for the site.
Sun Pharma Advanced Research Company is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
