Opicapone in Parkinson’s Disease
In its first-quarter earnings conference call, Neurocrine Biosciences (NBIX) highlighted plans to submit an NDA (new drug application) seeking approval for an investigational catechol-O-methyltransferase inhibitor, Opicapone, for treating multi-fluctuation in PD (Parkinson’s disease) patients, in the second quarter. In 2016, the drug was launched in the European market by BIAL under the trade name of ONGENTYS. In February 2017, Neurocrine Biosciences entered an in-licensing agreement with BIAL for Opicapone.
According to Neurocrine Biosciences’ first-quarter earnings investor presentation, around 1 million people are affected by PD in the US. Two out of every three PD patients are on carbidopa/levodopa therapy, considered as a standard of care regimen. However, since these regimens have been shown to lose their efficacy over time, dosage and frequency of dosage need to be adjusted multiple times, which highlights the significant unmet demand in this segment.
Elagolix in uterine fibroids
Neurocrine Biosciences expects partner AbbVie (ABBV) to submit an NDA seeking FDA approval for Elagolix in the uterine fibroids indication in mid-2019. According to Neurocrine Biosciences’ first-quarter earnings investor presentation, Elagolix was discovered and developed up to Phase 2 by Neurocrine Biosciences and was then developed by AbbVie. Around three million women in the US are diagnosed with symptomatic uterine fibroids, while 450,000 new patients are diagnosed annually. Additionally, 250,000 hysterectomies are performed annually to manage the symptoms associated with uterine fibroids. Since only one drug has been approved by the FDA in the past 20 years for this indication, Elagolix is expected to target a largely underserved market opportunity.
NBI-74788 in CAH
According to Neurocrine Biosciences’ first-quarter earnings investor presentation, the company plans to begin a Phase 2 trial evaluating investigational therapy NBI-74788 in theCAH (congenital adrenal hyperplasia) indication in the third quarter. In March 2019, the company issued a press release announcing positive interim results from the Phase II proof-of-concept study evaluating NBI-74788 in the CAH indication.
According to Neurocrine Biosciences’ first-quarter earnings investor presentation, the company expects to have a portfolio of three assets approved across four indications by the end of fiscal 2020.