Date: 2017-02-09
Type of information: Licensing agreement
Compound: Ongentys® (opicapone)
Company: Neurocrine Biosciences (USA - CA) Bial (Portugal)
Therapeutic area: Neurodegenerative diseases
Type agreement: licensing
Action mechanism:
- enzyme inhibitor/COMT inhibitor. Ongentys® (opicapone) is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor that increases L-DOPA plasma levels when used concomitantly with L-DOPA/DOPA-decarboxylase inhibitors (DDCIs). Opicapone increases the bioavailability of levodopa by up to 55% vs placebo.
- The drug 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.
Disease:
Details:
- • On February 9, 2017, Neurocrine Biosciences and BIAL announced that they have entered into an exclusive licensing agreement for the development and commercialization of opicapone in North America. Under the terms of the agreement, Neurocrine will be responsible for development and commercialization of opicapone in the United States and Canada. Upon the completion of technology transfer from BIAL, Neurocrine intends to meet with the FDA to discuss a potential New Drug Application submission.
Financial terms:
- Neurocrine will make an upfront payment of $30 million and will fund all development activities necessary for FDA approval. BIAL is eligible to receive additional milestone payments of approximately $115 million from 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.
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Is general: Yes
