The San Diego-based biotech turned to Portugal’s Bial for North American rights to Ongentys (opicapone), a once-daily COMT inhibitor approved in Europe as an adjunctive therapy for Parkinson’s disease.
Bial is getting $30 million upfront and up to $115 million in milestones in the deal. And once the deal is done, Neurocrine execs plan to sit down with the FDA and talk about a new drug application.
Analysts seem to have modest hopes in terms of peak sales. Noted Leerink’s Paul Matteis.
Considering the prior size of (standard add-on) entacapone (~$230MM US in 2010), the differentiation of opicapone against the price-pressures from generics, we think it’s realistic that the asset could be a minor profitable P&L contributor at ~$75MM to ~$100MM in peak sales.
“Securing the commercial rights to opicapone in the United States and Canada is another important step in expanding our movement disorders franchise,” said Neurocrine CEO Kevin C. Gorman. “Opicapone is a significant late stage asset with outstanding clinical data and a long period of exclusivity. Upon FDA approval, it will allow us to further leverage our commercial infrastructure and bring much needed relief to the one million people in the United States suffering from the symptoms of Parkinson’s disease.”
The European Commission based its approval of the drug last July on a pair of pivotal phase III studies, BIPARK-I1 and BIPARK II2, that demonstrated that a once-daily dose “achieved an absolute reduction in OFF-time of 2 hours without increasing ON-time with troublesome dyskinesia, statistically significant reductions in absolute OFF-time compared to placebo (P=0.0015) and statistically significant increases in ON-time without troublesome dyskinesia compared to placebo (P=0.002).”
Neurocrine is already coming up on an April 11 PDUFA date for valbenazine, filed for tardive dyskinesia. Recently the biotech also announced that a Phase II study of valbenazine for Tourette syndrome had failed. Bial, meanwhile, was slammed last year after one of its experimental drugs, BIA 10-2474, which blocks the enzyme FAAH was used at a lethal dose in a small trial in France.
One patient in that study died and five others were seriously harmed.
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