Sun Pharma, SPARC sign licensing pact for epilepsy drug ‘Elepsia XRTM’

Sun Pharma Advanced Research Company Ltd (SPARC) and Sun Pharmaceutical Industries Ltd today announced a licensing arrangement for SPARC's epilepsy drug `Elepsia XRTM' (Levetiracetam extended release tablets).

As per the agreement, SPARC will license Elepsia (XRTM) 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) tablets.

Sun Pharma said the USFDA had approved Elepsia (XR) tablet 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 said it has undertaken a detailed remediation at Halol for restoring cGMP compliance status for the site.

''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. Elepsia XRTM 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. If and when the USFDA reapproves the Elepsia XRTM application, Sun Pharma's significant US presence will help SPARC in commercialising this important product for patients in the US market,'' Anil Raghavan, CEO, SPARC, said.

''The in-licensing of Elepsia XRTM will facilitate Sun Pharma's anticipated entry into the proprietary CNS segment in the US. This is a part of Sun Pharma's strategy, to strengthen its presence in the US specialty segment through its newly created Sun Neurosciences business unit. We believe that SPARC's Wrap Matrix technology will help in differentiating Elepsia XRTM amongst other competing products,'' Kirti Ganorkar, senior vice president, business development, Sun Pharma, added.

Elepsia XRTM is a novel investigational product designed as an extended release formulation of Levetiracetam 1000mg and 1500mg. Elepsia XRTM has been developed using SPARC's proprietary Wrap Matrix platform technology.

Levetiracetam products currently approved by FDA and available on the US market are generally indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. As per IMS MAT December 2015, over 9 million prescriptions were dispensed for Levetiracetam making it one of the most widely prescribed treatments for epilepsy in the US.

Sun Pharma Advanced Research Company Ltd. (SPARC) is an international pharmaceutical company engaged in research and development of drugs and delivery systems.