ORPHELIA Pharma and Biocodex sign a license agreement for the distribution of Kigabeq® in 14 european countries

Paris and Gentilly – April 6th 2021 – ORPHELIA Pharma and Biocodex announce today the execution of an exclusive distribution and marketing agreement for Kigabeq® (vigabatrin) for most of the European Union territory, including France.

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.

 About Biocodex

Funded in 1953 beyond the development and marketing of the first probiotic strain in the world, Saccharomyces boulardii CNCMI-745, Biocodex from pioneer became one of leading international players within microbiota.

Biocodex further extended its activities to nervous central system diseases, with a focus on pediatric neurology, reinforcing its commitment to improve quality of life through discovery of innovative drugs addressed to unmet medical needs: full development of antiepileptic drug stiripentol (DIACOMIT®), indicated for the treatment of Dravet syndrome which is a serious and rare epilepsy observed in infants, has brought a valid therapeutic solution to neuropaediatricians.

Initially approved in Europe in 2007 then Canada and Japan in 2012, Diacomit® obtained Marketing Authorization in USA and Switzerland in 2018, Australia in 2019 and recently in Argentina. In numerous other countries, patients could access the drug through specific compassionate use programs. Dedicated medical team is in charge of orphan drugs portfolio, with permanent connexion with neuropaediatric specialists in UE and worldwide.

About ORPHELIA Pharma

ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of pediatric and orphan diseases.

Our mission is to provide patients with essential hospital products in the fields of epilepsy and oncology, with formulations that are suited to the pediatric population. Our 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. Our second product, Ivozall®, obtained a European marketing authorization at the end of 2019 for the treatment of acute lymphoblastic leukemia. ORPHELIA Pharma also conducts research projects through academic and industrial partnerships.

Contacts

Séverine MARTIN / orphelia@orphelia-pharma.eu / +33 (0)1 42 77 08 18

Véronique STALLER / v.staller@biocodex.fr /+33 (0)1 41 24 30 84

6 April 2021

License agreement for the distribution of Kigabeq® in 14 european countries
6 April 2021

ORPHELIA Pharma and Biocodex sign a license agreement for the distribution of Kigabeq® in 14 european countries Paris and Gentilly – April 6th 2021 – ORPHELIA Pharma and Biocodex announce today the execution of an exclusive distribution and marketing agreement for Kigabeq® (vigabatrin) for most of the European Union territory, including France. 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.  About Biocodex Funded in 1953 beyond the development and marketing of […]
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6 April 2021

Accord de licence pour la distribution de Kigabeq® dans 14 pays européens
6 April 2021

ORPHELIA Pharma et Biocodex signent un accord de licence pour la distribution de Kigabeq® dans 14 pays européens Paris et Gentilly – le 6 avril 2021 – ORPHELIA Pharma et Biocodex annoncent ce jour avoir signé un accord de distribution et de commercialisation de Kigabeq® (vigabatrine) dans une grande partie du territoire de l’Union Européenne, dont la France. Kigabeq®, la première forme pédiatrique de vigabatrine développée par ORPHELIA Pharma, est indiqué, entre autres, dans le traitement des spasmes infantiles (syndrome de West). Kigabeq® est approuvé en Europe, où ce médicament destiné exclusivement aux enfants bénéficie d’une autorisation de mise sur le marché centralisée (Paediatric Use Marketing autorisation, PUMA). « Nous sommes très heureux d’annoncer cette collaboration avec la société Biocodex », déclare Hugues BIENAYME, fondateur et Directeur Général d’ORPHELIA Pharma. « En raison de sa grande expérience dans le domaine de l’épilepsie pédiatrique et des maladies rares, Biocodex est certainement le meilleur partenaire pour la distribution de Kigabeq® en Europe ». « Avec Kigabeq®, seule présentation pédiatrique de vigabatrine, Biocodex étoffe son portefeuille de médicaments destinés aux pathologies rares et graves de l’enfant » ajoute Nicolas COUDURIER, Directeur Général de Biocodex. « Kigabeq® et Diacomit® (stiripentol, développé et commercialisé par Biocodex) , sont deux médicaments répondant à un besoin médical important pour de jeunes patients souffrant d’épilepsies sévères et pharmacorésistantes ». « Notre objectif est de mettre Kigabeq® à la disposition de l’ensemble des cliniciens européens, tout particulièrement des neuropédiatres, pour que les enfants touchés par le syndrome de West puissent en bénéficier », conclut Gilles ALBERICI, Président d’ORPHELIA Pharma, « Grâce à cet accord avec Biocodex, Kigabeq® pourra désormais être prescrit dans la majeure partie du territoire européen ». À propos de Kigabeq® Kigabeq® est la première formulation pédiatrique de vigabatrine, un médicament antiépileptique essentiel sous forme de comprimés solubles dosés à 100 mg et 500 mg de vigabatrine pour administration par voie orale ou (naso)gastrique, Kigabeq® est indiqué notamment dans le traitement des spasmes infantiles (syndrome de West), une encéphalopathie épileptique gravissime du nourrisson. Kigabeq® a été développé exclusivement pour l’enfant et bénéficie d’une autorisation de mise sur le marché pédiatrique européenne (Paediatric Use Marketing Autorisation, PUMA). A propos des spasmes infantiles Le syndrome de West, ou spasmes infantiles, est une encéphalopathie épileptique gravissime du nourrisson qui associe des spasmes épileptiques, une détérioration psychomotrice et un tracé électroencéphalogramme de type hypsarythmique. C’est une maladie rare, avec une incidence estimée à 5 pour 10 000 naissances. Elle peut survenir chez un […]
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2 February 2021

Opening of the operating pharmaceutical establishment
2 February 2021

ORPHELIA Pharma opens its operating pharmaceutical establishment (“laboratoire pharmaceutique exploitant”) in France Paris and Lyon, February 2nd, 2021. ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs, announces today that it has opened its operating pharmaceutical establishment (“laboratoire pharmaceutique exploitant”) in France. According to the French Public Health Code (“Code de la Santé Publique”), ORPHELIA Pharma will now be able to commercialize medicines under its own name. The authorized activities include importation, sales, advertising, medical information, pharmacovigilance and batch monitoring. The establishment will also be able to launch and monitor early access programs (“Autorisation Temporaire d’Utilisation”, or ATU) on its own behalf or on behalf of third parties. “As of today, we will be able to commercialize our own medicines in France. We currently have two pediatric medicines which have been approved in Europe through a centralized procedure: Kigabeq® (vigabatrin) and Ivozall® (clofarabine)”, comments Laurent Martin, Chief Pharmaceutical Officer of ORPHELIA Pharma. “Becoming a pharmaceutical establishment will also allow us to initiate an early access program (ATU) for our experimental medicine Kimozo®, a liquid oral formulation of temozolomide developed for the treatment of relapsed or refractory neuroblastoma, following validation by health authorities”, he adds. “After having obtained the authorization to open our pharmaceutical establishment from the French medicines agency (ANSM) on November 18th, 2020, this effective opening is a major milestone for our company and is a testament to the efforts undertaken by the people at ORPHELIA Pharma”, concludes Hugues Bienaymé, General Manager. 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 rare 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®, received European marketing authorization in September 2018 and has been made available in several countries. Our second product, Ivozall®, obtained European marketing authorization in November 2019 for the treatment of acute lymphoblastic leukemia. ORPHELIA Pharma conducts research projects through academic and industrial collaborations.
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2 February 2021

Ouverture de l’établissement pharmaceutique exploitant
2 February 2021

ORPHELIA Pharma annonce l’ouverture de son établissement pharmaceutique exploitant en France Paris et Lyon, le 2 février 2021. ORPHELIA Pharma, société biopharmaceutique française dédiée au développement et à la commercialisation de médicaments pédiatriques et orphelins annonce aujourd’hui avoir ouvert son établissement pharmaceutique exploitant en France. Conformément au Code de la Santé Publique, ORPHELIA Pharma pourra désormais exploiter en son nom des médicaments commerciaux. L’exploitation comprend les opérations d’importation, de vente, de publicité, d’information médicale, de pharmacovigilance, et de suivi des lots. Cet établissement permettra également d’exploiter des Autorisations Temporaires d’Utilisation (ATU), pour le compte d’ORPHELIA Pharma ou de tiers. « Cette ouverture permet d’exploiter dès à présent en France nos propres médicaments avec Autorisation de Mise sur le Marché. Nous avons en effet 2 médicaments pédiatriques approuvés en Europe par procédure centralisée : Kigabeq® (vigabatrine) et Ivozall® (clofarabine)», commente Laurent Martin, Directeur des Affaires Pharmaceutiques et Pharmacien Responsable d’ORPHELIA Pharma, « Devenir établissement pharmaceutique nous permettra également d’envisager la mise à disposition sous statut ATU de notre médicament expérimental Kimozo®, formulation buvable de témozolomide développée pour le traitement du neuroblastome réfractaire ou en rechute, après validation par les autorités sanitaires », ajoute-t-il. « Après avoir obtenu l’autorisation d’ouverture de notre établissement pharmaceutique exploitant de l’Agence Nationale de Sécurité du Médicament (ANSM) le 18 novembre 2020, cette ouverture effective est un jalon important pour la société et vient couronner le travail de l’ensemble de l’équipe d’ORPHELIA Pharma », conclut Hugues Bienaymé, Directeur Général.  A propos d’ORPHELIA Pharma ORPHELIA Pharma est une société biopharmaceutique basée à Paris et Lyon qui développe et commercialise des médicaments pour le traitement de maladies pédiatriques et des maladies rares. Notre mission est de fournir aux patients des produits hospitaliers essentiels dans les domaines de l’épilepsie et de l’oncologie avec des formulations adaptées à la population pédiatrique. Notre premier produit, Kigabeq®, a obtenu une autorisation de mise sur le marché européenne en septembre 2018 et est disponible dans plusieurs pays. Notre second produit, Ivozall®, a plus récemment obtenu une autorisation de mise sur le marché européenne pour le traitement de la leucémie aiguë lymphoblastique. ORPHELIA Pharma mène ses projets de recherche par le biais de collaborations académiques et industrielles.
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