As per the press release the agreement is for Levetiracetam extended release tablet, ELEPSIA XR. This drug was approved by the US FDA in March, 2015 but was rescinding back in September, 2015 due to the compliance issues at SUN’s manufacturing facility i.e. Halol. (As per ET now, USFDA has deferred plans to re-inspect Sun Pharma’s Halol plant from July 13 to a later unconfirmed date).
Sun Pharma has confirmed that a detailed remediation plan has been undertaken for restoring cGMP (Current Good Manufacturing Practices) status at this site.
As per the agreement, SPARC will license Levetiracetam Extended Release tablets to a wholly-owned subsidiary of Sun Pharma for the US market against which it will receive an up-front payment of US$10 million and will be eligible to receive additional milestone payments and defined royalties linked to any future sales of ELEPSIA XR.
The in-licensing of ELEPSIA XR will facilitate Sun Pharma’s anticipated entry into the proprietary CNS segment in the US which will be done through its newly created Sun Neurosciences business unit.
The product is used in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. As per IMS MAT December 2015, 9 million prescriptions were dispensed for Levetiracetam making it one of the most widely prescribed treatments for epilepsy in the US.
Here is what Anil Raghavan, CEO, SPARC said: “ELEPSIA XR is designed as a novel once-a-day formulation of Levetiracetam using SPARC’s proprietary Wrap MatrixTM technology. It is designed to reduce pill burden and help improve convenience and compliance in these patients.”
He also added that if and when the USFDA reapproves the ELEPSIA XR application, Sun Pharma’s significant US presence will help SPARC in commercializing this important product for patients in the US market.
Sun Pharma Advanced Research Company (SPARC) is an international pharmaceutical company engaged in research and development of drugs and delivery systems and Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company with over has 48 manufacturing facilities across six continents. The company is due to announce their results on the 28th July 29.
Religare Research expects a QoQ growth of 7.6% in Net Profits at Rs. 1,844.4 crore and Net Sales by 5.2% to Rs. 8,029.8 crore.
Edelweiss expects a 16% growth in Net Profits at Rs. 1,988.3 crore and Net Sales by 9.3% to Rs. 8,106.7 crore.
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