PORTO, Portugal, October 17, 2016 /PRNewswire/ --
ONGENTYS® (opicapone) has now been launched in the UK for the treatment of adult Parkinson´s disease patients with motor fluctuations.
ONGENTYS® (opicapone) was authorised by the European Commission in June 2016 as 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 stabilised on those combinations.
Several therapeutic strategies are available to improve the signs and symptoms of Parkinson´s disease, mainly dopaminergic drugs avoiding the degradation or mimicking dopamine physiological effects. Levodopa remains the gold-standard treatment for the disease, although its long-term use causes what is known as motor complications, like end of dose motor complications or wearing-off. "Wearing-off" episodes may be improved with appropriate changes in the medication regimen, i.e. adding an extra dose of levodopa or using a COMT inhibitor.
"There is still an unmet medical need for effective new therapeutic options for Parkinson´s disease. Opicapone will provide clinicians in UK with a COMT inhibitor, with the convenience of once-daily dosing. It is an option when levodopa-treated patients need additional help to improve motor symptoms such as wearing off in Parkinson´s disease.", said Professor Andrew Lees, Professor of Neurology at the National Hospital for Neurology and Neurosurgery, Queen Square, London and University College London.
"Studies have shown that ONGENTYS® (opicapone) is an effective, once-daily, 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 stabilised on those combinations. We are pleased that opicapone is now available in UK, a country where BIAL has recently opened an affiliate. Opicapone is the outcome of BIAL's longstanding scientific commitment to neurological research. These launches also reflect BIAL's increasing European footprint and the company's mission to care for the Health of people worldwide", comments António Portela, CEO of BIAL.
The European Commission authorisation for opicapone was based on data from a clinical development programme which included 28 human pharmacology studies with more than 900 patients exposed to opicapone in 30 countries worldwide. The two pivotal phase III studies, BIPARK-I and BIPARK-II demonstrated that opicapone once-daily achieved an absolute reduction in OFF-time of 103 and 107 minutes respectively and statistically significant increases in ON-time without troublesome dyskinesia compared to placebo (P=0.002).
Opicapone was also associated with significant improvements in both patient and clinician global assessments of change. BIPARK-I was an active-controlled trial and included an entacapone arm: opicapone once-daily demonstrated to be non-inferior to entacapone dosed multiple times per day. The data from the phase III trials demonstrated that opicapone improves motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors use. It has also been demonstrated to have a generally favourable safety and tolerability profile in the whole trial population and in the subset of patients over 70 years, and is not associated with relevant electrocardiographic or hepatic adverse events.
Both phase III trials included a 1-year open-label extension and opicapone demonstrated an OFF-time reduction from the double-blind phase baseline that was sustained over the open-label phase
BIAL anticipates additional EU launches of opicapone over the coming year. The company recently opened affiliates in Frankfurt and London, so as to strengthen its internationalisation strategy and the commercialisation of its medicines in those countries.
Parkinson's disease is a neurodegenerative, chronic and progressive disease. The clinical manifestations usually start after the age of 50 years (average age for diagnosis is approximately 60 years) and the prevalence is estimated at 300 per 100,000 inhabitants, increasing to 1/100 over the age of 55-60 years. According to the European Parkinson's Disease Association (EPDA) around 6.3 million people have Parkinson's worldwide. Along with available statistics, 1.2 million people in the European Union have Parkinson's, approximately 260,000 in Germany and 120,000 in UK.
About ONGENTYS® (opicapone)
Opicapone is a third-generation catechol-O-methyltransferase (COMT) inhibitor. It was rationally designed to provide a peripherally selective high COMT inhibitory potency and to avoid cell toxicity.
Opicapone dose dependently increases the bioavailability of levodopa by up to 55% vs placebo and this translates into a dose-dependent reduction in OFF time. Molecular structure resulted in an exceptionally high binding affinity (fentomolar) that translates into a slow complex dissociation rate constant and a long duration of action that allows once daily dosing.
About the BIPARK-I study
BIPARK-I was a phase III, randomised, double-blind, active- and placebo-controlled, parallel group efficacy and safety study with an open-label 1-year extension phase in levodopa-treated patients with idiopathic Parkinson's disease and motor fluctuations.
The efficacy and safety of three different doses (5, 25 and 50 mg) of opicapone administered once-daily, compared with entacapone (200 mg) or placebo administered with each dose of levodopa, were assessed. Opicapone 50mg once-daily was superior to placebo and non-inferior to entacapone.
The study enrolled 600 patients from 106 study sites in Europe. Patients were 34-83 years-old and had a diagnosis of idiopathic Parkinson's disease for at least 3 years; had a modified Hoehn & Yahr Scale stage of ≤3 in the ON state; had to receive optimum levodopa therapy (3-8 daily doses), stable for at least 4 weeks; had signs of end-of-dose deterioration (wearing-OFF) for at least 4 weeks with a mean daily OFF-time of 1.5 hours while awake, not including morning pre-first dose OFF-time; and had the ability to keep accurate 24-hour diaries. Patients were randomly assigned in a 1:1:1:1:1 ratio to opicapone 5 mg, 25 mg or 50 mg, entacapone and placebo.
The primary endpoint was the mean change from baseline in absolute OFF-time, as measured by 24-hour diaries. Secondary endpoints included proportion of responders, Investigators' and Subjects' Global Assessment of Change, UPDRS, quality of life, non-motor symptoms and sleep scales, tolerability and safety assessments. Ninety percent (542/600) of patients completed the study.
About the BIPARK-II study
BIPARK-II was a phase III, randomised, double-blind placebo-controlled study with an open-label 1-year extension phase in levodopa-treated patients with idiopathic Parkinson's disease and end-of-dose motor fluctuations.
The efficacy and safety of two different doses (25 and 50 mg) of opicapone, administered once-daily, were compared with placebo, administered with each dose of levodopa, were assessed. Mean reduction in absolute OFF-time in both the 25 and 50 mg OPC groups was greater than in the placebo arm.
286 patients completed the study from 69 multinational study sites. Patient´s inclusion criteria and trial assessments (primary and secondary outcomes) were similar to BIPARK-I.
About Parkinson's disease
Parkinson's disease is a neurodegenerative, chronic and progressive disease, characterized 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. The clinical manifestations usually start after the age of 50 years (average age for diagnosis is approximately 60 years) and the prevalence is estimated at 300 per 100,000 inhabitants, increasing to 1/100 over the age of 55-60 years.
Diagnosis is based on clinical observation. A diagnosis of Parkinson's disease can be made in patients who present with at least two of the three cardinal signs: resting tremor, rigidity and bradykinesia. Tremor is particularly important, as it is present in 85% of patients with Parkinson's; a diagnosis of Parkinson's disease is particularly difficult when tremor is absent. Other frequent symptoms include postural instability, masked face and decreased eye blinking, stooped posture, and decreased arm swing.
Founded in 1924, BIAL's mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has strategically focused on quality, innovation and internationalisation.
BIAL's has nine affiliates and its products are in pharmacies of more than 50 countries. Since May 2016 BIAL has had its own affiliate in the UK.
Being the partner of choice for many pharma companies, BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in Research and Development (R&D) every year.
BIAL has established an ambitious R&D programme centred in neurosciences, cardiovascular system and allergic immunotherapy. BIAL's innovative programmes focus on continuing the clinical development of its epilepsy drug ZEBINIX®/APTIOM® (eslicarbazepine acetate) on the market in Europe and the US, as well as ONGENTYS® (opicapone) for Parkinson's disease.
The company expects to continue to introduce new medicines and vaccines to the market in the next years, strengthening its position worldwide and accomplishing the company's purpose of "Caring for your Health".
For more information about BIAL, please visit http://www.bial.com.
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Job code: ON/SEP16/UK/068
Date of preparation: September 2016