Actionable insights on equities, fixed-income, macros and personal finance Start 14-Days Free Trial
Actionable investing insights Get Free Trial

Sun Pharma Advanced Research inks deal with Sun Pharmaceutical Industries for Epilepsy Drug


Sun Pharma Logo

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.

Related Post: US FDA Warning Letter to Sun Pharmaceutical Industries for Halol facility

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.

Dilip Sanghvi2

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.

Sun Pharma Share Price 18 July 2016

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 expects16% growth in Net Profits at Rs. 1,988.3 crore and Net Sales by 9.3% to Rs. 8,106.7 crore.

Holdings: Analyst and family do own stock listed above. Please assume we are biased.



Nothing in this newsletter is financial advice and should not be construed as such. Please do not take trading decisions based solely on the matter above; if you do, it is entirely at your own risk without any liability to Capital Mind. This is educational or informational matter only, and is provided as an opinion. 

Disclosure: The authors at Capital Mind have positions in the market and some of them may support or contradict the material given above, or may involve a direction derived from independent analysis.


Like our content? Join Capitalmind Premium.

  • Equity, fixed income, macro and personal finance research
  • Model equity and fixed-income portfolios
  • Exclusive apps, tutorials, and member community
Subscribe Now Or start with a free-trial