- Neurocrine Biosciences is dropping at least $30 million for access to a Parkinson's disease drug that could help build out the company's neurological portfolio.
- The drug in question, Ongentys (opicapone), comes from Portuguese drugmaker Bial. Ongentys received E.U. approval last summer as an adjunct therapy to levodopa decarboxylase inhibitors, which help regulate dopamine concentrations in the body and serve as a treatment for Parkinson's.
- In addition to $30 million upfront, Bial could receive up to $115 million in milestone payments, as well as a fee and royalties that amount to 37% of net sales in the U.S.
While Ongentys hasn't yet received Food and Drug Administration approval, Neurocrine plans to meet with the agency after a technology transfer to discuss getting the drug to market.
The companies are hoping to hold that meeting before year's end. Jefferies analysts expect the agency would require an additional clinical trial for Ongentys before greenlighting the treatment in the U.S., and therefore a new drug application wouldn't come until 2020.
The deal is an overall positive for Neurocrine, the investment firm added. While the FDA has approved other generic and branded drugs, such as Novartis' Comtan (entacapone), that function the same as Ongentys, those alternatives require more frequent dosing or have demonstrated less effectiveness, according to meta analysis.
Ongentys also represents a strategic fit for Neurocrine. The company is already preparing for an FDA decision on its highly anticipated tardive dyskinesia drug, Ingrezza (valbenazine). Should Ongentys gain approval as well, it would offer "commercial synergies with Ingrezza with only a marginal increase in sales/marketing head count," as well as hold a similar patent life, Jefferies said. Ingrezza currently has composition of matter exclusivity until 2029.
Per deal terms, Neurocrine is responsible for manufacturing and selling Ongentys in the U.S. and Canada as well as the costs associated with pushing the drug through the FDA regulatory process.
Access to a potentially profitable product is surely a welcome turnaround for Neurocrine, which in the last month saw Ingrezza fail a mid-stage study evaluating it as a treatment for Tourette syndrome in adults.