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M8 Pharmaceuticals Announces License of Exclusive rights for Diacomit® (Stiripentol) from Biocodex SAS

Sep 14, 2021

m8 Pharmaceuticals and Biocodex have signed an exclusive licensing agreement for the Mexican and Brazilian market for Diacomit® (stiripentol). Diacomit® is approved for adjunctive treatment with clobazam and valproate in Dravet syndrome in over 27 countries, including North America and Europe. Dravet syndrome, also known as severe myoclonic epilepsy in infancy (SMEI), is a catastrophic early onset epileptic syndrome that is thought to affect approximately 1,000 to 2,000 patients in Mexico, and approximately 2,000 to 4,000 patients in Brazil. In most cases, the first seizures occur during the first year of life. Dravet syndrome is characterized by severe epilepsy, psychomotor retardation, and often ataxia. Status epilepticus is frequent and is thought to be in part responsible for the high premature mortality rate reported in these patients, ranging from 15.9 to 18%.

The addition of Diacomit® to the m8 portfolio further reinforces the company’s position as a Latin American leader in the CNS space.

“We remain committed to bringing products to Latin America. Actively partnering with neurologists to address the unmet needs of patients and their families, as is the case of this devastating orphan disease which mainly affects children…” said Joel Barlan, m8’s CEO.

“We are pleased to have entered into this collaboration with m8 which is a major step forward to Diacomit development in Latin America. With this partnership in Mexico and Brazil, we are aiming at providing access to Diacomit to a large number of patients suffering from this severe condition” adds Nicolas Coudurier, CEO of Biocodex

About Diacomit® (stiripentol) Diacomit® is an antiseizure medication developed by Laboratories Biocodex. Possible mechanisms of action of its anticonvulsant effect in humans include increase of GABAergic inhibition, inhibition of lactate dehydrogenase and blockage of sodium and calcium channels.Diacomit® is now approved by FDA in two formulations (capsules and powder for oral suspension). Biocodex received orphan-drug designation for Diacomit® from the FDA in 2008 and full approval in 2018.Diacomit® is also approved for adjunctive treatment with clobazam and valproate in Dravet syndrome in 27 countries in the EU (January 2007), Canada (December 2012), Japan (September 2012), Australia (September 2019), Argentina (December 2020) and Taiwan (June 2021).

About Biocodex Biocodex is an independent multinational pharmaceutical company founded in France in 1953. It is headquartered in Gentilly (France) with its American subsidiary in San Mateo (CA). The company is focused on discovering, developing and commercializing innovative therapeutics relating to the central nervous system (epilepsy, pain management, psychiatry), gastroenterology (microbiota) and women health.

For any information please contact:

Thomas Couroussé Head of Neurology division T: +33 (0)1 41 24 46 69

Joel Barlan Chief Executive Officer T: +52 (55) 4431 2933

Rafael Ferrer Vice President of Corporate Development T: +1 (305) 299 6998