ONGENTYS® ▼ (opicapone) approved in Japan

Porto, 30 June 2020 - BIAL announced today that ONGENTYS® ▼ (opicapone) tablets 25 mg received a manufacturing and marketing approval in Japan for the improvement of the end-of-dose motor fluctuations (wearing-off phenomenon) in Parkinson's disease in combination with levodopa-carbidopa or levodopa–benserazide hydrochloride.

“We are very pleased to achieve this regulatory milestone for opicapone. After Europe and the U.S., this approval is a landmark in BIAL’s R&D program, reinforcing our ongoing commitment to the quality of life of patients worldwide. Opicapone offers patients living with Parkinson´s disease an effective, once-daily adjunctive treatment option to the gold standard levodopa/dopa-decarboxylase inhibitors preparations and we look forward to working with our partner in the Japan, Ono Pharmaceutical Co., Ltd., to make this therapy available to Japanese patients.” said António Portela, CEO of BIAL.

This approval is mainly based on the results of a multi-center, placebo controlled, randomized, double-blind, parallel group study and an open-label, uncontrolled, long-term extension study conducted in Japan in patients with Parkinson's disease with wearing-off phenomenon treated with levodopa (dopamine precursor) and a DOPA decarboxylase inhibitor (DDCi) (ONO-2370-02 study). This study demonstrated superiority of opicapone compared to placebo in the primary endpoint (change in OFF-time from baseline). In addition, the study showed that there were no newly concerned adverse drug reactions associated with opicapone and that the drug was well tolerated.

In April 2013, BIAL and Ono Pharmaceutical Co., Ltd. entered into an exclusive licensing agreement for the development and commercialization of opicapone in Japan.

Parkinson's disease is a neurodegenerative, chronic and progressive disease. It is the second most common neurodegenerative disease after Alzheimer’s disease, with a prevalence of approximately 0.5–1% among those 65–69 years of age, rising to 1–3% among persons 80 years of age and older. In Japan the number of patients with Parkinson’s disease is estimated to be approximately 163,000.1

About Opicapone 2

Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT inhibitor.

Opicapone works by decreasing peripheral levodopa’s conversion rate into 3-O-methyldopa, thereby prolonging the duration of levodopa’s effect in reducing the OFF-time period of Parkinson’s and extending the ON-time period3,4,5.

In June 2016, the European Commission authorized Ongentys® (opicapone), hard capsules 25 mg and 50 mg, has an adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. In Europe opicapone is currently marketed in Germany, United Kingdom, Spain, Portugal and Italy. In April 2020, Ongentys® (opicapone), hard capsules 25 mg and 50 mg, was approved by the U.S Food and Drug Administration (FDA) as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

About Parkinson's disease

Parkinson's disease is a neurodegenerative, chronic and progressive disease, characterised by massive depletion of striatal dopamine because of degeneration of dopaminergic neurons in the brain (substantia nigra).

Epidemiological evidence points to a complex interaction between genetic vulnerability and environmental factors. PD is the second most common neurodegenerative disease after Alzheimer’s disease (AD), with a prevalence of approximately 0.5–1% among those 65–69 years of age, rising to 1–3% among persons 80 years of age and older. With an ageing population, both the prevalence and incidence of PD are expected to increase by more than 30% by 2030.6

The diagnosis of Parkinson's disease is based on clinical observation and relies on three key elements: bradykinesia (slow movements), resting tremor, and rigidity (muscle stiffness). Of these, bradykinesia must be present, with at least either tremor or rigidity. Other common symptoms are postural instability, reduced facial expression and blinking, and a slouching posture. The disease progressively incapacitates patients, causing hindrance in their lives and daily activities.

About BIAL

Founded in 1924, BIAL's mission is to research, develop and provide therapeutic solutions within the area of health. In the last decades, BIAL has focused strategically on quality, innovation and internationalisation. BIAL is strongly committed to therapeutic innovation, investing more than 20% of its annual turnover into research and development within neurosciences and the cardiovascular system. The company expects to introduce new drugs on the market in the coming years, strengthening its international presence based on proprietary drugs and achieving its goal of supplying innovative products to patients worldwide.

For more information on BIAL: www.bial.com

References

1. Statistics and Information Department, Minister’s Secretariat, Ministry of Health, Labour and Welfare. Patient Survey 2014 (Disease and Injury).”

2. Ongentys® EU SMPC. Last updated 22/04/2020.

3. Ferreira J., et al. Lancet Neurol. 2016 Feb;15(2):154-165

4. Ferreira J., et al. Neurology. 2018 May 22;90(21):e1849-e185

5. Lees A., et al. JAMA Neurol. 2017 Feb 1;74(2):197-206

6. Kouli A, et al. Parkinson’s Disease: Pathogenesis and Clinical Aspects. 2018 Ch 1