On April 6, 2021 ORPHELIA Pharma and Biocodex reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) for most of the European Union territory, including France (Press release, ORPHELIA Pharma, APR 6, 2021, View Source [SID1234577603]).
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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in Europe, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).
"We are very pleased to release this collaboration agreement with Biocodex", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their long-standing experience in the field of pediatric epilepsy, Biocodex is certainly the best partner for Kigabeq distribution in Europe".
"With Kigabeq, the only pediatric presentation of vigabatrin, Biocodex is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Nicolas Coudurier, CEO of Biocodex, " Kigabeq and Diacomit (stiripentol, developed and marketed by Biocodex) are two drugs which address unmet medical needs for young patients affected by severe and resistant to treatment epilepsies".
"Our objective is to make Kigabeq available to all European clinicians, so that children affected by West syndrome can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with Biocodex, Kigabeq will soon be prescribed in most of the European territory."
About Kigabeq
Kigabeq is the first pediatric formulation of vigabatrin, an essential anti-epileptic drug. Presented as soluble and scored tablets of 100 mg and 500 mg for oral or nasogastric administration, Kigabeq is notably indicated for the treatment of infantile spasms (West syndrome), an extremely serious epileptic encephalopathy of the infant. Kigabeq was developed exclusively for children and has been granted European Pediatric Marketing Authorization (PUMA).
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.