BIAL announced on 2nd September 2021 that it has entered into an agreement with Sunovion Pharmaceuticals Inc. (Sunovion) whereby BIAL received exclusive commercial license rights to commercialise apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) and the United Kingdom. Apomorphine sublingual film (APL-130277) is a novel thin film formulation of…
Category: Parkinson’s Disease
Istradefylline: CHMP issues negative opinion for in Europe
On 23rd July, Kyowa Kirin Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people…
Bial and Medis partnership
13 July 2021: BIAL and Medis, d.o.o. have entered into an exclusive partnership on two of BIAL’s proprietary drugs: Zebinix® (eslicarbazepine acetate) and Ongentys® (opicapone). The established partnership comprises an exclusive distribution agreement for Zebinix® (eslicarbazepine acetate) in the Czech Republic and Slovakia and an exclusive distribution agreement for Ongentys® (opicapone) in 12 CEE countries…
Study to investigate the efficacy of opicapone in early-stage Parkinson’s disease (PD)
The design for a new phase III, double-blind, randomised trial for opicapone has been presented for the first time at the European Academy of Neurology (EAN) congress. Around 50% of patients with PD experience some degree of motor complications within 2–5 years of starting L-dopa/DDCI therapy and almost all develop such symptoms after 10 years…
New real-world data for ONGENTYS®▼ (opicapone) released at the MDS
New data presented 12-16 September at the MDS 2020 Virtual Congress further support the efficacy and tolerability of ONGENTYS® (opicapone) observed in pivotal Phase III studies. Opicapone is a once-daily catechol-O-methyltransferase (COMT) inhibitor, approved for the treatment of end-of-dose motor fluctuations in adult PD patients taking levodopa. Data from OPTIPARK study demonstrated consistently low incidence of treatment-related adverse events in clinical practice from the…
