Knight Therapeutics, Amneal Pharmaceuticals enter license agreement

Knight Therapeutics (KHTRF) entered into an exclusive license agreement with Amneal Pharmaceuticals (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 extended-release capsules designed for the treatment of Parkinson’s disease. Financial terms of the agreement were not disclosed. IPX203 contains immediate-release granules and extended-release coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. 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 and showed that treatment with IPX203 demonstrated statistically significant improvement in daily “Good On” time with fewer doses of IPX203 compared with immediate-release carbidopa-levodopa, with IPX203 dosed a mean three times per day vs 5 times per day for immediate-release carbidopa-levodopa.