Bioprojet Pharma SAS and AOP Orphan announce signing of the distribution agreement for Wakix® (pitolisant) in Austria, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Slovenia and Sweden.
Wakix® (pitolisant) was centrally approved by the European Medicines Agency (EMA) for treatment of adults suffering from narcolepsy with or without cataplexy, a rare, disabling, long-term disease. Narcoleptic patients have an irresistible urge to sleep, even at inappropriate times and places, and a disturbed night-time sleep. Cataplexy refers to muscle weakness that can cause collapse when severe.
"Distributing Wakix® (pitolisant) is in the strategic scope of AOP Orphan to give patients access to a new, innovative medicine in a rare and serious disease, such as narcolepsy, in our geographical area of focus, namely Austria, Nordic countries and Central Eastern Europe," states Dr. Rudolf Widmann, Chief Executive Officer, AOP Orphan. Dr. Georg Fischer, Chief of Corporate Development, AOP Orphan adds "Wakix® (pitolisant) strengthens AOP's neurology focus and is a perfect addition to our portfolio. With Wakix® (pitolisant) we now have extended our neurology portfolio to three products on the market and two further products in clinical development".
Chief Executive Officer, Bioprojet Pharma SAS, Jean-Guillaume Lecomte, comments "With Wakix® (pitolisant) we address a significant unmet medical need in the treatment of narcolepsy. Next to introducing Wakix in Western Europe with its own commercial organisations, Bioprojet is glad to expand Wakix access to narcolepsy patients and their physicians all over Northern and Central Eastern Europe with the support of AOP Orphan.
About Wakix® (Pitolisant)
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist which enhances the activity of histaminergic neurons, which maintains wakefulness. The drug was approved by the EMA in 2016 for the treatment of narcolepsy in adults with or without cataplexy. Pitolisant has an orphan designation in the European Union.
Narcolepsy is a rare, chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, cataplexy, a sudden loss of muscle control triggered by emotions, and hallucinations among other symptoms. Two types of narcolepsy are currently recognized according to the ICSD3 diagnostic criteria, Type 1 and 2. Type 1 is associated with cataplexy and a reduction in of hypocretin-1 levels, while Type 2 is not associated with cataplexy.
Bioprojet is a pharmaceutical company headquartered in Paris, France. Its activity is focused on the design, synthesis and development of novel classes of drugs for unmet medical needs, such as Racecadotril (Tiorfan ®, Hidrasec) and Pitolisant (Wakix®). Bioprojet is commercially active in 7 western European countries through its own organisation and commercially covering the rest of the word through distributors and licensees
About AOP Orphan Pharmaceuticals AG
AOP Orphan is a multinational company with headquarters in Vienna, Austria focusing on clinical research, development and distribution of medicines for rare and complex diseases. The company also provides individualized and customized services to meet and accommodate the needs of physicians and patients across Europe, the Middle East & Asia. Currently AOP Orphan is concentrating on orphan and complex diseases in HematoOncology, Cardiology & Pulmonology, and Neurology & Metabolic Disorders.
Chief Executive Officer
Bioprojet Pharma SAS
T.: + 33 1 47 03 66 26,
Dr. Georg Fischer
Chief of Corporate Development
AOP Orphan Pharmaceuticals AG
T.: + 43 1 503 72 44 15
Business Unit Director Neurology & Metabolic Disorders
AOP Orphan Pharmaceuticals AG