LONDON: Clinigen Group plc), the global pharmaceutical Products and Services company, and ORPHELIA Pharma, a pharmaceutical company specialised in orphan and paediatric medicines, 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 gain access to 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.”