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Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)
ONGENTYS® (opicapone) is a leading adjunctive therapy for the treatment of Parkinson’s Disease Complements Amneal’s existing Parkinson’s franchise and
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nONGENTYS® (opicapone) is a leading adjunctive therapy for the treatment of Parkinson’s Disease\n\n\n\nComplements Amneal’s existing Parkinson’s franchise and further expands specialty portfolio\n\n\n\n BRIDGEWATER, N.J. & PORTO, Portugal--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023. Amneal expects to begin distribution of ONGENTYS® in early 2024.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231207320607/en/\nONGENTYS® is BIAL’s proprietary once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor), approved by the U.S. Food and Drug Administration (“FDA”) in 2020 as an add-on treatment to carbidopa/levodopa (CD/LD) in patients with Parkinson’s disease (PD) experiencing “Off” episodes.\n\n\nCarbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s. As the disease progresses, patients on LD start experiencing motor complications such as the “wearing-off phenomenon,” which are periods where LD is no longer providing enough relief from PD symptoms and people experience what is referred to as “Off” time. Wearing-off is common, with around 50% of patients reporting it in the first five years after PD diagnosis.1 “Off” time can greatly disrupt a patient’s daily routine by inhibiting their ability to perform tasks or care for themselves.\n\n\nONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time. ONGENTYS offers patients living with Parkinson´s disease an effective, once-daily adjunctive treatment option for “Off” episodes. It is the first and only LD optimizer approved for once-daily use. Amneal views ONGENTYS® as highly complementary to Rytary® and IPX203.\n\n\n“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 understa...