Paris and Lyon, on July 21st, 2021 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs and Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical Products and Services company, announce that they have signed an exclusive agreement to manage the supply and distribution of Kigabeq® into unlicensed markets.
Kigabeq® was granted a European Paediatric Use Marketing Authorization (PUMA) in September 2018 and is currently approved for the treatment of infantile spasms (West Syndrome) and pharmaco-resistant focal-onset seizures (partial seizures).
Under the terms of the agreement, Clinigen will provide access to Kigabeq® 500 mg and 100 mg soluble tablets into markets where Kigabeq® is not commercially available. Clinigen will manage all elements of the supply including healthcare practitioner enquiry management, regulatory oversight, logistics and access management. The agreement currently covers all global territories except for USA, China, EU, UK and Bangladesh.
Sam Herbert, Chief Operating Officer and Head of Products Division, Clinigen, said: “We are pleased to be partnering with ORPHELIA Pharma and to be supplying Kigabeq® through our product lifecycle platform. This agreement will offer healthcare professionals another option to treat difficult-to-manage types of epilepsy. This is a great example of how Clinigen’s lifecycle platform can help patients source medicines which are not otherwise available.”
Hugues Bienaymé, General Manager of ORPHELIA Pharma added: “We are delighted to have entered into this collaboration with Clinigen. With this agreement, our ambition to make Kigabeq® available worldwide, will be fulfilled.”
Healthcare professionals can obtain details about the products by calling the Clinigen customer service team at +44 (0) 1932 824100, emailing MedicineAccess@clinigengroup.com or going online at www.clinigendirect.com.
Patients seeking medical information should contact their physician.
About ORPHELIA Pharma
ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of paediatric and orphan diseases. Its mission is to provide patients with essential hospital products in the fields of epilepsy and oncology, with formulations that are suited to the paediatric population. ORPHELIA’s first product, Kigabeq®, which was approved during the latter part of 2018 for the treatment of West Syndrome in particular, has been launched in several European countries. Its second product, Ivozall®, obtained a European marketing authorization at the end of 2019 for the treatment of acute lymphoblastic leukaemia. ORPHELIA Pharma also conducts research projects through academic and industrial partnerships.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist pharmaceutical services and products platform focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 16 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 34 of the top 50 pharmaceutical companies; interacting with over 5,000 hospitals across more than 115 countries.
For more information on Clinigen, please visit http://www.clinigen.com