Clinigen and ORPHELIA Pharma sign an exclusive agreement to supply Kigabeq® (vigabatrin)

Clinigen Group plc (AIM: CLIN, ‘Clinigen’), 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.”

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.

Contact details

Clinigen Group plc
Sam Herbert
Group Chief Operating Officer & Head of Products Division
+44 (0) 1283 495010
investors@clinigengroup.com

Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Hodgson
Tel: +44 (0) 20 3709 5700
Clinigen@consilium-comms.com

ORPHELIA Pharma
Séverine MARTIN
Tel: +33 (0)1 42 77 08 18
orphelia@orphelia-pharma.eu

Notes to Editors

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

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.

For further information, please go to www.orphelia-pharma.eu

About Kigabeq®

Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:

Treatment in monotherapy of infantile spasms (West's syndrome).

Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.

https://www.ema.europa.eu/en/documents/product-information/kigabeq-epar-product-information_en.pdf

About infantile spasms

West syndrome, or infantile spasms, is an extremely serious epileptic encephalopathy in infants that combines epileptic spasms, psychomotor deterioration and a hypsarrhythmic type electroencephalogram. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in an infant with previously normal development or with a pre-existing delay; in all cases, infantile spasms severely hamper the psychomotor development. Pharmacological treatment should be started quickly to allow the spasms to stop and to improve the prognosis.