ORPHELIA Pharma and DESITIN GmbH announce the launch of Kigabeq® in Germany

Paris/Lyon and Hamburg, July 16, 2019 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that it has entered into a license and distribution agreement with the epilepsy specialist Desitin GmbH to market Kigabeq® in Germany.

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug, available as scored soluble tablets of 100 mg and 500 mg strengths for oral and (naso)gastric administration. Kigabeq® has been developed exclusively for children and has been granted a Paediatric Use Marketing Authorization (PUMA) by the European Commission in October 2018. Kigabeq® is the first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy.

« This is a key milestone for ORPHELIA Pharma and for Kigabeq®, our first product to receive EU approval and to reach the market. Kigabeq® addresses a significant unmet medical need in a rare and potentially devastating form of epilepsy and we are convinced that it will improve the life of children affected by this condition » comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma.

« Kigabeq® is an appropriate therapeutic option and is highly appreciated as new part of our antiepileptic portfolio », Martin Zentgraf, General Manager of Desitin says. « We have started promotion of Kigabeq® in July 2019 already which will hopefully be well accepted for its use in pediatric patients ».

« As a renowned specialist in epilepsy, Desitin is the best possible partner for Kigabeq® in Germany » adds Gilles Alberici, President of ORPHELIA Pharma. « Germany is the first country where we launch our first approved product. We are now preparing the market access in France and ORPHELIA Pharma looks forward to building relationships with other distribution partners to market Kigabeq® throughout Europe. This agreement marks our transition from a development to a commercial-stage company ».

About infantile spasms

West Syndrome, or infantile spasms, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor retardation and an hypsarrhythmic electroencephalogram. It is a rare disease with an estimated incidence of around 5 per 10,000 living births. It affects infants whose development was normal or children with impaired cognitive development prior to spasms. Children with infantile spasms must be treated as soon as possible to stop spasms and improve prognosis.

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament. For more information, please visit www.orphelia-pharma.eu

About Desitin GmbH – CNS in Focus; People in Mind

Based in Hamburg, Desitin Arzneimittel GmbH is marketing pharmaceutical products in international countries. At our Hamburg plant we produce sophisticated products for the treatment of neurological and psychiatric illnesses and offer a large number of established and innovative products, especially for our core indications epilepsy and Parkinson’s syndrome. The optimisation of pharmacotherapy through continuous development and in cooperation with other future-oriented companies, is one of Desitin’s main areas of activity and investment. For more information, please visit https://www.desitinpharma.com