India’s Sun Pharma Advanced Research Company (SPARC) has licensed its novel epilepsy drug Elepsia XR (levetiracetam) to its parent, Mumbai-based Sun Pharmaceutical Industries, as a way to speed up U.S. market entry following manufacturing issues that prevented a launch last year.
Under the terms of the deal, SPARC gets $10 million in an upfront payment as well as milestone and royalty payments linked to sales.
SPARC had received approval for the drug from the U.S. FDA in March 2015 and at the time said it was evaluating partners for commercial sales that were initially forecast at about $50 million annually.
However, the manufacture of the product at the Halol plant owned by the parent was delayed because of manufacturing violations cited by the U.S. FDA.
In a release, Sun said it is at work on bringing the Halol site up to compliance and suggested the licensing deal will aid the introduction of Elepsia into the market without providing details.
“The in-licensing of ELEPSIA XR will facilitate Sun Pharma’s anticipated entry into the proprietary CNS segment in the U.S.," Kirti Ganorkar, senior vice president for Business Development at the parent said in a statement.
"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."
Last year, Reuters had reported that the company had worked "very aggressively" to find partners for the product and was in "some advanced discussions" to launch by the second half of fiscal 2016.
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