Amneal, BIAL ink U.S. licensing agreement for Ongentys

Amneal and BIAL have reached a licensing agreement where Amneal will have exclusive rights to market and distribute Ongentys (opicapone) in the United States starting on Dec. 18, 2023. Amneal expects to begin distribution of Ongentys in early 2024.

Ongentys is BIAL’s proprietary once-daily, peripherally-acting, highly selective catechol-O-methyltransferase inhibitor, approved by the Food and Drug Administration in 2020 as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes.

“As a company committed to the Parkinson’s community, Amneal continues to look for more ways to serve and support people with PD, their loved ones, and the physicians who treat them,” said Joe Renda, senior vice president, chief commercial officer specialty. “We understand the importance of minimizing ‘Off’ time and increasing “On” time without troublesome dyskinesia when treating PD. We look forward to working with BIAL to ensure Ongentys remains available for patients in the U.S. and look to further grow this key adjunctive therapy. This is an exciting complement to our specialty branded portfolio and pipeline of best-in-class treatment options for PD.”

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“We are fully committed to creating value for people living with severe neurological conditions worldwide, being the U.S. is a key geography for BIAL. Amneal shares our long-term vision for Ongentys, and our partnership will allow us to expand its accessibility, continuing to make a difference for patients suffering from Parkinson’s disease in the U.S.,” said Max Bricchi, executive vice president, chief commercial officer of BIAL.

The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance, Amneal said.

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