Neurocrine and BIAL announce exclusive North American licensing agreement for opicapone.

Neurocrine Biosciences, Inc. and BIAL announced that they have entered into an exclusive licensing agreement for the development and commercialization of opicapone in North America. Ongentys (opicapone) is a once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor) that was approved in June 2016 by the European Commission as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.

“Securing the commercial rights to opicapone in the United States and Canada is another important step in expanding our movement disorders franchise,” said Kevin C. Gorman, chief executive officer of Neurocrine Biosciences. “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.”

“We are pleased to have Neurocrine as our partner in developing and commercializing opicapone,” said Antonio Portela, chief executive officer of BIAL. “We believe this partnership is another landmark for BIAL. Neurocrine has extensive experience in developing therapies for movement disorders and shares our long-term vision for opicapone, we look forward to bringing this important new treatment option to Parkinson’s patients in the United States.”

“Opicapone potentially addresses two significant needs for individuals with Parkinson’s disease; extending the timeframe when motor symptoms are adequately controlled as well as once-daily dosing which greatly simplifies the treatment regimen,” said Christopher O’Brien, chief medical officer of Neurocrine Biosciences. “We look forward to working with the FDA to bring this novel therapy to Parkinson’s patients.”

Under the terms of the agreement, Neurocrine will be responsible for development and commercialization of opicapone in the United States and Canada. Neurocrine will make an upfront payment of $30 million and will fund all development activities necessary for U.S. Food and Drug Administration (FDA) approval. BIAL is eligible to receive additional milestone payments of approximately $115 millionfrom Neurocrine for the achievement of certain development, regulatory and commercial milestones. In addition, Neurocrine will pay BIAL a percentage of net sales in exchange for the manufacture and supply of opicapone drug product. 

Upon the completion of technology transfer from BIAL, Neurocrine intends to meet with the FDA to discuss a potential New Drug Application submission. 

(Source: PR Newswire)