The BIAL group received approval from the European Commission for the market introduction of the drug ONGENTYS® (opicapon), with an indication for the treatment of Parkinson's disease, thus culminating an 11-year investigation into a new molecule.
After the approval of ONGENTYS® by the European Commission, BIAL expects to be able to make this new medicine available by the end of the year in some European markets and during 2017 in the others.
Known until now by the name of the active ingredient, opicapone, ONGENTYS® is a new COMT (catechol-O-methyltransferase) inhibitor, once daily, indicated as an adjunct therapy to levodopa in adult patients with Parkinson's disease and motor fluctuations that are not controlled with other therapies. ONGENTYS® reduces the so-called OFF-time period, which is characterized by a state of profound immobility of patients.
First described in 1817, Parkinson's disease is highly disabling and affects the motor skills of its sufferers. The European Parkinson's Disease Association (EPDA) estimates that 1,2 million people in the European Union suffer from Parkinson's disease, including 22 thousand Portuguese.
António Portela, CEO of BIAL, says that the approval of ONGENTYS® by the European Commission “is the result of the company's commitment to research and development of innovative therapeutic solutions. It represents a lot for BIAL and its collaborators, after the approval of ZEBINIX® for epilepsy, the first Portuguese drug, ONGENTYS® is the second drug to be developed in Portugal with approval by the European authorities. There are many years of effort and dedication by a very competent and highly qualified team. ONGENTYS® is further proof of our ability to innovate and is above all a new hope for doctors and patients. The approval of ONGENTYS® reinforces our ability to successfully implement a long-term strategy focused on innovative therapies”.
The ONGENTYS® molecule began to be studied by BIAL 11 years ago. It is the second medicine with a Portuguese patent to reach the market, after the commercialization of ZEBINIX® (eslicarbazepine acetate) for the treatment of epilepsy, already available in Europe and the United States.
BIAL is an international pharmaceutical company with products available in over 50 countries. The search for new therapeutic solutions has been the main focus of the company for more than two decades, which annually allocates around 20% of its turnover to R&D, which has represented more than 40 million euros.
Comments