Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)
Details : Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experi...
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 12, 2023
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 24, 2022
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available ...
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 15, 2022
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 06, 2022
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data demonstrated that newly approved Ongentys significantly reduced "off" time as an add-on therapy in patients with Parkinson's Disease taking Levodopa/Carbidopa only in a pooled Post-Hoc, sub-group analysis of Phase III studies.
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 09, 2020
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Bial
Deal Size : Undisclosed
Deal Type : Agreement
BIAL and Recipharm Expand Long-Term Supply Agreement for Opicapone API
Details : The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 10, 2020
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Bial
Deal Size : Undisclosed
Deal Type : Agreement