Ongentys (Neurocrine/Bial/Ono Pharmaceutical) is a once-daily formulation of the catechol-O-methyltransferase (COMT) inhibitor opicapone, approved as an add-on therapy to levodopa for the treatment of Parkinson’s disease patients with end-of-dose motor fluctuations. Being a COMT inhibitor, Ongentys limits peripheral levodopa metabolism, thus increasing the molecule’s delivery to the brain. This prolongs the effect of each levodopa dose, and helps patients to remain free of motor symptoms for longer. In addition, as a third-generation COMT inhibitor, Ongentys is hypothesized to provide inhibitory potency while avoiding cell toxicity.
Ongentys was first approved in the EU in July 2016, where it is marketed by Bial. In February 2017, Bial and Neurocrine entered into a licensing agreement for the development and marketing of Ongentys in North America. Neurocrine anticipates filing Ongentys for regulatory approval in the US in H1 2019, without needing to conduct a separate US clinical trial. Ono Pharmaceutical has exclusive rights to develop and commercialize Ongentys in Japan.
LIST OF FIGURES
8 Figure 1: Ongentys for Parkinson’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Ongentys for Parkinson’s disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ongentys for Parkinson’s disease
12 Figure 4: Ongentys sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Ongentys drug profile
7 Table 2: Ongentys pivotal trial data in Parkinson’s disease
13 Table 3: Ongentys sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25
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