ORPHELIA Pharma and Ethypharm sign a licensing agreement for the development and marketing of Kigabeq® in China

Saint-Cloud and Paris – January 19, 2021 – Ethypharm and ORPHELIA Pharma announce today the signature of an exclusive agreement for the development, registration and marketing in the People’s Republic of China of Kigabeq® (vigabatrin) indicated for the first-line treatment of infantile spasms (West syndrome).

 Kigabeq®, the first paediatric form of vigabatrin developed by ORPHELIA Pharma, is approved and marketed in Europe, where this medicine, intended exclusively for children, has been granted a Paediatric Use Marketing Authorisation (PUMA). Kigabeq® is indicated for the first-line treatment of infantile spasms (West’s syndrome), a severe epileptic encephalopathy in infants.

There is a significant unmet medical need in China for patients suffering from this rare and devastating form of epilepsy. By entering into this agreement, Ethypharm and ORPHELIA Pharma are committed to providing appropriate treatment for Chinese children suffering from this rare disease.

As part of this agreement, ORPHELIA Pharma grants Ethypharm exclusive rights to Kigabeq® in the People’s Republic of China. After registration, Ethypharm will be responsible for the distribution and sale of Kigabeq® in China.

 “Our objective is to make Kigabeq® available in many territories. After Europe and China, new agreements will be signed to enable the marketing of this formulation of vigabatrin, which is particularly suitable for children,” comments Hugues BIENAYME, founder and Managing Director of ORPHELIA Pharma.

 “We are very pleased to establish this partnership with ORPHELIA Pharma. This collaboration brings an effective solution to young Chinese patients. The upcoming commercialisation of Kigabeq® is fully in line with our strategy to strengthen our rare disease franchise in China” said Bertrand DELUARD, President and CEO of Ethypharm.

 Through this partnership, Ethypharm is strengthening its ambition to become a key player in the field of rare diseases in China. Operating successfully for more than 20 years in an ever-changing Chinese environment, Ethypharm has a fully integrated subsidiary located in Shanghai. “Our subsidiary is a partner of choice for companies wishing to make their existing internationally-marketed orphan drugs or drugs for rare diseases available to Chinese patients,” says François LIOT, General manager of Shanghai Ethypharm.

“I am delighted to sign this agreement with Ethypharm, which is based on the value of Kigabeq® in paediatrics. Thanks to the in-depth knowledge that the Ethypharm Group is developing in China, we are very confident that chinese children suffering from infantile spasms will have access to Kigabeq® as quickly as possible,” adds Gilles ALBERICI, Chairman of ORPHELIA Pharma.

About Kigabeq®

Kigabeq® is the first paediatric formulation of vigabatrin, an essential anti-epileptic drug. Kigabeq® is available in 100 mg and 500 mg soluble and scored tablets for oral or (naso)gastric administration and is indicated for the first-line treatment of childhood spasms (West’s syndrome), a severe epileptic encephalopathy in infants. Kigabeq® has been developed exclusively for children and has been granted Paediatric Use Marketing Authorisation (PUMA).

About infantile spasms

West’s syndrome, or infantile spasms, is a severe epileptic encephalopathy of the infant that combines epileptic spasms, a psychomotor deterioration and an hypsarrhythmic electroencephalogram tracing. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in infants with previously normal development or with a pre-existing delay; in all cases, infantile spasms have a strong impact on the psychomotor development. Pharmacological treatment must be started quickly to allow the spasms to stop and improve the prognosis.

 About the Ethypharm Group

Ethypharm is a European pharmaceutical company focused on two therapeutic areas: the Central Nervous System and Critical Care. Ethypharm markets its drugs directly in Europe and China, and with partners in North America and the Middle East where its drugs are in high demand. The Group employs more than 1,500 people, mainly in Europe and China.

Ethypharm works closely with authorities and healthcare professionals to ensure the appropriate use of and access to its medicines, by as many people as possible.

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 authorisation in September 2018 and is being launched in several countries. Our second product, Ivozall®, obtained European marketing authorisation in November 2019 for the treatment of acute lymphoblastic leukaemia. ORPHELIA Pharma conducts research projects through academic and industrial collaborations.

Press contact

Avril PONNELLE / presse@ethypharm.com / + 33 (0)1 41 12 17 20

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

19 January 2021

Signature of a licensing agreement for the development and marketing of Kigabeq® in China
19 January 2021

ORPHELIA Pharma and Ethypharm sign a licensing agreement for the development and marketing of Kigabeq® in China Saint-Cloud and Paris – January 19, 2021 – Ethypharm and ORPHELIA Pharma announce today the signature of an exclusive agreement for the development, registration and marketing in the People’s Republic of China of Kigabeq® (vigabatrin) indicated for the first-line treatment of infantile spasms (West syndrome).  Kigabeq®, the first paediatric form of vigabatrin developed by ORPHELIA Pharma, is approved and marketed in Europe, where this medicine, intended exclusively for children, has been granted a Paediatric Use Marketing Authorisation (PUMA). Kigabeq® is indicated for the first-line treatment of infantile spasms (West’s syndrome), a severe epileptic encephalopathy in infants. There is a significant unmet medical need in China for patients suffering from this rare and devastating form of epilepsy. By entering into this agreement, Ethypharm and ORPHELIA Pharma are committed to providing appropriate treatment for Chinese children suffering from this rare disease. As part of this agreement, ORPHELIA Pharma grants Ethypharm exclusive rights to Kigabeq® in the People’s Republic of China. After registration, Ethypharm will be responsible for the distribution and sale of Kigabeq® in China.  “Our objective is to make Kigabeq® available in many territories. After Europe and China, new agreements will be signed to enable the marketing of this formulation of vigabatrin, which is particularly suitable for children,” comments Hugues BIENAYME, founder and Managing Director of ORPHELIA Pharma.  “We are very pleased to establish this partnership with ORPHELIA Pharma. This collaboration brings an effective solution to young Chinese patients. The upcoming commercialisation of Kigabeq® is fully in line with our strategy to strengthen our rare disease franchise in China” said Bertrand DELUARD, President and CEO of Ethypharm.  Through this partnership, Ethypharm is strengthening its ambition to become a key player in the field of rare diseases in China. Operating successfully for more than 20 years in an ever-changing Chinese environment, Ethypharm has a fully integrated subsidiary located in Shanghai. “Our subsidiary is a partner of choice for companies wishing to make their existing internationally-marketed orphan drugs or drugs for rare diseases available to Chinese patients,” says François LIOT, General manager of Shanghai Ethypharm. “I am delighted to sign this agreement with Ethypharm, which is based on the value of Kigabeq® in paediatrics. Thanks to the in-depth knowledge that the Ethypharm Group is developing in China, we are very confident that chinese children suffering from […]
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19 January 2021

Signature d’un contrat de licence pour le développement et la commercialisation de Kigabeq® en Chine
19 January 2021

ORPHELIA Pharma et Ethypharm signent un contrat de licence pour le développement et la commercialisation de Kigabeq® en Chine Saint-Cloud et Paris – 19 janvier 2021 – Ethypharm et ORPHELIA Pharma annoncent ce jour la signature d’un accord exclusif pour le développement, l’enregistrement et la commercialisation en République Populaire de Chine de Kigabeq® (vigabatrine) indiqué dans le traitement de première intention des spasmes infantiles (syndrome de West).  Kigabeq®, la première forme pédiatrique de vigabatrine développée par ORPHELIA Pharma, est approuvé et commercialisé en Europe où ce médicament destiné exclusivement aux enfants bénéficie d’une autorisation de mise sur le marché pédiatrique (Paediatric Use Marketing autorisation, PUMA). Kigabeq® est indiqué dans le traitement de première intention des spasmes infantiles (syndrome de West), une encéphalopathie épileptique gravissime du nourrisson.  Il existe en Chine un important besoin médical non satisfait pour les patients souffrant de cette forme rare d’épilepsie dévastatrice. En concluant cet accord, Ethypharm et ORPHELIA Pharma s’engagent à fournir un traitement approprié aux enfants chinois atteints de cette maladie rare. Dans le cadre de cet accord, ORPHELIA Pharma accorde à Ethypharm les droits exclusifs sur Kigabeq® en République Populaire de Chine. Après l’enregistrement, Ethypharm sera responsable de la mise sur le marché, de la distribution, et de la vente de Kigabeq® sur le territoire chinois. « Notre objectif est de mettre à disposition Kigabeq® dans de nombreux territoires. Après l’Europe et la Chine, de nouveaux accords seront passés pour permettre la commercialisation de cette formulation de vigabatrine particulièrement adaptée aux enfants » déclare Hugues BIENAYME, fondateur et Directeur Général d’ORPHELIA Pharma.   « Nous sommes très heureux d’établir ce partenariat avec ORPHELIA Pharma. Cette collaboration apporte une solution optimisée aux jeunes patients chinois. La commercialisation prochaine de Kigabeq® s’inscrit ainsi pleinement dans notre stratégie de renforcement de notre franchise maladies rares en Chine ” dit Bertrand DELUARD, président et Directeur Général d’Ethypharm. A travers ce partenariat, Ethypharm renforce son ambition de devenir un acteur clé dans le domaine des maladies rares en Chine. Opérant avec succès depuis plus de 20 ans dans un environnement chinois en perpétuelle évolution, Ethypharm dispose d’une filiale entièrement intégrée située à Shanghai. « Notre filiale est un partenaire de choix pour les entreprises qui souhaitent mettre à disposition des patients chinois leurs médicaments orphelins ou pour des maladies rares déjà commercialisés à l’échelle internationale », indique François LIOT, Directeur de la filiale Ethypharm Shanghai. « C’est un plaisir de conclure cet accord avec […]
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12 October 2020

ORPHELIA Pharma organise un Symposium lors du congrès SIOP 2020
12 October 2020

Cher Docteur, ORPHELIA Pharma vous convie à son symposium sur l’utilisation du témozolomide dans la prise en charge des tumeurs pédiatriques et le développement de Kimozo, la première suspension orale de témozolomide prête à l’emploi et au goût masqué adaptée aux enfants. Le symposium intitulé « Improving children care with temozolomide oral suspension » se tiendra lors du prochain congrès annuel de la SIOP qui se déroulera du 14 au 17 octobre 2020 dans un format entièrement virtuel. Au cours de cette session, deux cliniciens de renommée internationale, le Dr Lucas Moreno (Hôpital Vall d’Hebron à Barcelone) et le Dr Dominique Valteau-Couanet (Gustave Roussy à Villejuif) présenteront la place du témozolomide dans le traitement des tumeurs pédiatriques récidivantes ou réfractaires et plus particulièrement dans les neuroblastomes. Leur intervention sera suivie de celle du Dr Caroline Lemarchand, Directeur du Développement Pharmaceutique de notre laboratoire, qui présentera Kimozo, la première forme pédiatrique de témozolomide en développement clinique. Ce symposium aura lieu le vendredi 16 octobre 2020 de 9h15 à 9h35 (heure locale Ottawa), de 15h15 à 15h35 en France. Pour y assister, vous devez vous connecter au site de la SIOP (SIOP-Congress.org), entrer votre identifiant et votre mot de passe remis lors de votre inscription au congrès, cliquer sur « Product Theatre » et choisir le symposium virtuel d’ORPHELIA Pharma. Espérant vous compter parmi nous à l’occasion de cet évènement, je vous souhaite d’ores et déjà un excellent congrès SIOP 2020. Bien cordialement, Pierre-Julien COTTE
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12 October 2020

ORPHELIA Pharma to organize a Symposium at the SIOP congress 2020
12 October 2020

Dear Doctor, ORPHELIA Pharma is delighted to invite you to attend its symposium on the use of temozolomide in the management of pediatric tumors and the development of Kimozo, the first ready-to-use, taste-masked oral suspension of temozolomide suitable for children. The symposium entitled “Improving children care with temozolomide oral suspension” will be held during the next SIOP annual congress which will take place from October 14th to 17th, 2020 in a fully virtual format. During this session, two internationally renowned clinicians, Dr Lucas Moreno (Vall d’Hebron Hospital in Barcelona) and Dr Dominique Valteau-Couanet (Gustave Roussy in Villejuif) will highlight the role of temozolomide in the treatment of relapsed or refractory pediatric tumors and more particularly in neuroblastomas. Their speech will be followed by Dr Caroline Lemarchand, Director of Pharmaceutical Development of our laboratory, who will present Kimozo, the first pediatric formulation of temozolomide under clinical development developed by ORPHELIA Pharma. This symposium will take place on Friday, October 16, 2020 from 9:15 a.m. to 9:35 a.m. (local Ottawa time), from 3:15 p.m. to 3:35 p.m. Central European Time (CET). To attend, you must connect to the SIOP website (SIOP-Congress.org), enter your username and password given when you registered for the congress, click on “Product Theater” and choose the virtual symposium of ORPHELIA Pharma. Hoping to have you with us on this occasion, I already wish you an excellent SIOP 2020 congress. Best regards, Pierre-Julien COTTE
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