Knight Therapeutics Inc., a specialty pharmaceutical firm, announced Thursday that it has obtained an exclusive license from Amneal Pharmaceuticals, Inc. This agreement grants Knight the exclusive rights to seek regulatory approval and distribute IPX203 across Canada and Latin America.
IPX203 is an innovative, orally administered formulation of carbidopa/levodopa (CD/LD) extended-release capsules. It was developed specifically for the treatment of Parkinson's disease. Although the specifics of the financial agreement between the firms remain undisclosed, the implications are significant for both.
The formulation of IPX203 features a combination of immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules are made up of CD and LD, supplemented with a disintegrant polymer to enable quick dissolution.
This formulation was assessed during the RISE-PD clinical trial—a 20-week, randomized, double-blind, active-controlled, phase 3 clinical study involving 630 patients. The study successfully met all its primary and secondary goals, paving the way for the distribution of IPX203.
