Specialty pharmaceutical company Knight Therapeutics Inc. (GUD.TO) announced Thursday it has entered into an exclusive license agreement with Amneal Pharmaceuticals, Inc. (AMRX), granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America.
IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed for the treatment of Parkinson's disease. Financial terms of the agreement were not disclosed.
IPX203 contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution.
IPX203 was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The RISE-PD study met its primary and secondary endpoints.
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