“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 said in a release.
SPARC will receive an up-front payment of US $10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIATM XR, it added.
The company said ELEPSIATM 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.
At 10:01 AM, SPARC was up 6% at Rs 371 on the BSE with a combined 891,155 shares changing hands on the BSE and NSE so far. Sun Pharma was up 1% at Rs 779 on the BSE as compared to 0.5% rise in the S&P BSE Sensex.
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