BIAL and Wanbang Announce Exclusive Licensing Agreement for Opicapone in China
Ongentys® (Opicapone) is a new treatment for Parkinson’s Disease approved by the European Commission in June 2016
Porto, Portugal and Xuzhou, China, January 9th, 2018 - BIAL and Jiangsu Wanbang Biopharmaceutical Group Co., Ltd. (Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196 and HKG: 02196) announced today that they have entered into an exclusive license agreement for the importation, packaging and commercialization of Opicapone in China (excluding Hong Kong, Macao and Taiwan).
Under the terms of the agreement, BIAL will receive from Wanbang an upfront license fee of 2.5 million euros and up to 12.5 million euros in further milestones.
Ongentys® (Opicapone) is BIAL’s proprietary once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor) that was approved in June 2016 by the European Commission as an adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations1.
“BIAL is committed to addressing the needs of patients and healthcare professionals worldwide. This license agreement is a landmark on BIAL’s expanding strategy as it marks the entering of our products in such an important market like China.”, said António Portela, Chief Executive Officer of BIAL. “We are very pleased to work with Wanbang that shares our long-term vision for Ongentys® and are excited to bring this important new treatment option to Chinese Parkinson’s patients.”
“We are pleased to partner with BIAL to introduce Opicapone to China for patients with Parkinson’s disease.”, said Mr. Yifang Wu, Executive Director, President and Chief Executive Officer of Fosun Pharma, and Chairman of Wanbang. “We were impressed with the efficacy, safety and once-daily administration regimen of Opicapone. This collaboration will offer an alternative treatment for the unmet medical needs in China, and enrich the product portfolio of Wanbang and Fosun Pharma in the therapeutic area of CNS diseases, one of our strategic therapeutic areas. We look forward to collaborating with BIAL to import and commercialize Opicapone in China soon.”
Opicapone is marketed in European markets, like Germany, UK and Spain. BIAL anticipates additional EU launches of Opicapone over the current year.
Parkinson’s Disease is the second most severe neurodegenerative disease, with 7 to 10 million patients globally, next to Alzheimer's disease. According to some Chinese studies, in China, the incidence rate of Parkinson’s disease in population over than 65 years is 1700/100.000, indicating a patient population of 100 thousand new cases every year2.
Notes to Editors
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). The European Parkinson’s disease Association (EPDA), estimates that 1.2 million people live with Parkinson's disease in the European Union3.
The diagnosis is based on clinical observation and 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 true Parkinson's disease.
Several therapeutic strategies are available to improve the signs and symptoms of the disease, mainly dopaminergic that avoid the degradation or mimic dopamine physiological effects. Levodopa still remains the gold-standard treatment, although its long-term use causes what is known as motor complications, like end-of-dose motor fluctuations or wearing-off. This will lead to progressively shorter intervals during which symptoms remain adequately controlled. In other words, the effects of medication will start to "wear off' in between medication doses. “OFF-time” refers to periods of the day when the medication is not working well, causing worsening of Parkinsonian symptoms. In contrary, the term "ON-time" refers to periods of adequate control of the symptoms. "Wearing-off" episodes may occur predictably and gradually, or they may emerge suddenly and unexpectedly. The episodes may be improved with appropriate changes in the medication regimen, for example adding an extra dose of levodopa or using a COMT inhibitor.
Opicapone is a novel, once-daily, peripherally-acting, highly-selective COMT inhibitor proposed for use as adjunctive therapy to levodopa in Parkinson’s patients.
Opicapone works by prolonging the duration of effect of levodopa through decreasing its conversion rate into 3-O-methyldopa, thereby reducing the OFF-time period of Parkinson’s and extending the ON-time period. This novel compound discovered in the BIAL laboratories is designed to provide patients and physicians with a once-daily treatment option without the deleterious side-effects and complicated dosing regimen of other COMT inhibitors.
In June 2016, the European Commission authorized Ongentys® (Opicapone) as an adjunct 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. This European approval was based on data from a clinical development programme that included 28 human pharmacology studies with more than 900 patients exposed to Opicapone in 30 countries worldwide.
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 internationalization.
BIAL is strongly committed to therapeutic innovation, investing more than 20 per cent of its annual turnover in Research and Development (R&D) centered on the neurosciences and cardiovascular system. The company expects to introduce more new medicines to the market in the next years, strengthening its international presence based in its own innovative medicines and accomplishing the purpose of delivering innovative products to patients worldwide.
For more information about BIAL, please visit www.bial.com.
As one of the core members of Fosun Pharma, Wanbang has the first-class research and manufacturing site on prokaryotic and eukaryotic gene engineering drug and the leading recombinant protein product development technology for recombinant human insulin analogues and recombinant human erythropoietin.
Wanbang focuses on the development, manufacturing and distribution of pharmaceutical products concerning many treatment fields such as hypoglycaemic, hypertensive, hypolipidemic, uric acid, and cancer.
With the dedication to a healthier life, Wanbang is committed to bring innovative ideas, products and services to advance the health and well-being of people, to become a respected and innovation oriented first-tier enterprise in pharmaceutical industry.
For more information about Wanbang, please visit http://www.chinawanbang.com/
1- Ongentys® (Opicapone) SPC - Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002790/WC500209536.pdf Accessed January 2018
2- Chin. J. Contemp. Neurol. Neurosurg, Feb 2016, Vol. 16, No.2
3- EPDA website – Available at http://www.epda.eu.com. Accessed January 2018.
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