Amneal Pharmaceuticals, Inc. (NYSE: AMRX) experienced a notable upswing during the weekend session, registering a 7.89% increase to settle at $5.06. This positive trajectory in Amneal’s stock price was precipitated by a strategic agreement.
In a recent development, Amneal (AMRX) and BIAL – Portela & Ca. entered into a licensing arrangement, conferring exclusive rights to Amneal for the marketing and distribution of ONGENTYS (opicapone) in the United States, effective from December 18, 2023. Amneal anticipates initiating the distribution of ONGENTYS in early 2024.
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ONGENTYS, developed by BIAL, represents a proprietary, once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor). It received approval from the U.S. Food and Drug Administration (“FDA”) in 2020 as an adjunctive treatment to carbidopa/levodopa (CD/LD) for patients with Parkinson’s disease (PD) experiencing “Off” episodes.
CD/LD is a treatment aimed at managing PD symptoms and has held the status of the gold standard since the 1970s. However, as PD advances, patients on LD may encounter motor complications such as the “wearing-off phenomenon,” characterized by periods when LD no longer provides adequate relief from PD symptoms, resulting in what is known as “Off” time.
This wearing-off phenomenon is prevalent, affecting approximately 50% of patients within the first five years after a PD diagnosis. The “Off” time can significantly disrupt a patient’s daily activities, impeding their ability to perform tasks or attend to their own needs. In its dedication to the Parkinson’s community, Amneal remains steadfast in its pursuit of additional avenues to serve and support individuals with PD, their families, and the physicians overseeing their care.
Recognizing the significance of minimizing ‘Off’ time and augmenting “On” time without troublesome dyskinesia in PD treatment, AMRX is collaborating with BIAL to ensure the continued availability of ONGENTYS for U.S. patients and to further advance this crucial adjunctive therapy. While the financial specifics of the agreement have not been disclosed, any associated incremental expenses are factored into Amneal’s guidance.
