Sun Pharma Licenses Drug; Takes On Manufacturing RemediationBy
Sun Pharma Advanced Research Company (SPARC) and Sun Pharma have announced an arrangement for SPARC's Elepsia XTRM (levetiracetam extended-release tablets), an anti-epileptic drug, in which SPARC will license the product to a wholly owned subsidiary of Sun Pharma for the US market. SPARC will receive an upfront payment of $10 million from Sun Pharma and is eligible for certain additional milestone payments and defined royalties linked to any future sales of the drug.
Elepsia XRTM was approved by the US Food and Drug Administration (FDA) in March 2015, but SPARC received a letter from the FDA in September 2015 rescinding the earlier approval because the compliance status of the manufacturing facility at Sun Pharma's Halol, India site was not cGMP compliant at the time of approval. Sun Pharma has undertaken a remediation at the Halol site for restoring cGMP-compliance status.
The in-licensing of Elepsia XTRM is expected to facilitate Sun Pharma's entry into the central nervous system market segment in the US. Levetiracetam products currently approved by the 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.
Source: Sun Pharma