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License and distribution agreement for Kigabeq in the United Kingdom

29 October 2019

ORPHELIA Pharma and Veriton Pharma execute a license and distribution agreement for Kigabeq® in the United Kingdom

Paris/Lyon and Weybridge, October 29th, 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 Veriton Pharma to market Kigabeq® in the United Kingdom.

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug, available as scored 100 mg and 500 mg soluble tablets for oral and (naso)gastric administration. Kigabeq® has been developed exclusively for children aged between 1 month and 6 years and was granted a Paediatric Use Marketing Authorization (PUMA) in September 2018. Kigabeq® is indicated in the first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy.

« As a renowned specialist in the treatment of epilepsy, Veriton Pharma is an outstanding partner for Kigabeq® in the United Kingdom » comments Hugues Bienaymé, founder and General Manager of ORPHELIA Pharma. « After Germany, the UK is the second country where Kigabeq® will be offered to patients. We are now actively preparing launch of Kigabeq® in France and in other European countries with dedicated distribution partners. This new agreement confirms the continued attractiveness for Kigabeq® in Europe ».

« At Veriton Pharma, we are dedicated to providing tailored therapy options for people with special medical needs. We are excited to be the exclusive partner working alongside ORPHELIA in the UK and this collaboration aligns with Veriton’s core strategy to continuously deliver products to help support UK healthcare.», says Chris Grimes, Chief Commercial Officer of Veriton.

« This agreement with Veriton Pharma is an important step forward 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 it aims at improving the life of children affected by this condition » adds Gilles Alberici, Chairman of ORPHELIA Pharma.

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

ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of rare and serious paediatric diseases. Our mission is to provide patients with essential hospital products in the fields of epilepsy and oncology with formulations adapted to the paediatric population.

Our first product, Kigabeq®, obtained its Marketing Authorization in October 2018 and is being launched in Europe. Our second product, Ivozall®, received a positive opinion from the CHMP in September 2019 recommending the issuance of a European marketing authorization. ORPHELIA Pharma also conducts research projects through academic and industrial collaborations. The main investors are initiative OCTALFA and Pierre Fabre Medicament.

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About Veriton Pharma

Veriton Pharma is a private pharmaceutical company founded in 1997. The company is based in Weybridge UK with regional offices in The Middle East and Australia where it supplies products to over 25 countries worldwide. Veriton Pharma focuses on the development of licensed medicines, predominantly for CNS, and unlicensed medicines for patients with special requirements that licensed products cannot meet.

The company has a portfolio of more than 60 specialised formulations for treating conditions across a range of therapeutic areas. Veriton Pharma’s products are supported in the UK by a team of Regional Account Managers who are able to access the NHS at all critical levels. Similarly, both the MEA and Australian offices are able to provide experienced sales support within each of these areas.

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