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Norgine et Navidea nouent un partenariat européen pour LYMPHOSEEK®


News provided by

Norgine B.V.

Mar 06, 2015, 06:29 ET

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LONDRES, March 6, 2015 /PRNewswire/ --

Le premier traitement du genre pour la détection et la classification de cancers métastasés   

Norgine a annoncé aujourd'hui que sa filiale SpePharm AG avait passé un accord de sous licence exclusive avec Navidea Biopharmaceuticals Inc pour la commercialisation et la distribution de l'injection LYMPHOSEEK® (technetium Tc 99m tilmanocept) en Europe et sur d'autres marchés clés.

     (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a )

LYMPHOSEEK® nucléidique est approuvé en Europe pour l'imagerie et la détection peropératoire de ganglions lymphatiques sentinelles drainant la tumeur primaire chez des patients adultes souffrant d'un cancer du sein, d'un mélanome, ou d'un carcinome squameux localisé de la cavité buccale.[1]

LYMPHOSEEK® est conçu pour localiser les ganglions lymphatiques sentinelles et cartographier le drainage des ganglions lymphatiques de ces cancers.

Le cancer de la tête et du cou touche chaque année 100 000 personnes en Europe.[2] Dans une étude menée sur des patients ayant un carcinome squameux cutané ou intrabuccal à la tête et au cou, LYMPHOSEEK® identifiait correctement et avec précision dans 98,8 % des cas le cancer métastatique dans les ganglions lymphatiques locaux.[1] Cela signifie que les patients pourraient éviter l'intervention chirurgicale défigurante actuellement utilisée à ce stade du cancer.

Peter Stein, directeur général chez Norgine, a indiqué : « Notre partenariat avec Navidea est un exemple supplémentaire de l'engagement de Norgine à acquérir des produits pharmaceutiques spécialisés. Le cancer est une maladie dévastatrice qui demande des thérapies spécialisées pour permettre une détection et une classification correcte. Ce traitement innovant, premier dans son genre, favorisera la classification précise de cancers et permettra ainsi aux professionnels des soins de santé et aux patients de choisir le traitement le plus adapté. »

Rick Gonzalez, président et directeur général chez Navidea a commenté : « Étendre l'utilisation de LYMPHOSEEK® à de nouveaux marchés mondiaux fait partie intégrante de la stratégie de croissance de Navidea et nous pensons que l'expertise de Norgine dans la vente spécialisée et le marketing, associée à son infrastructure bien établie et sa présence forte sur le marché européen en fait un partenaire de commercialisation idéal pour atteindre l'indemnisation et étendre l'utilisation de LYMPHOSEEK® pays par pays. »

L'imagerie radio-pharmaceutique ciblant les récepteurs a été approuvée par la U.S. Food and Drug Administration en 2013 et par la European Medicines Agency en Novembre 2014.  

Selon les termes de l'accord, Navidea recevra un paiement initial de 2 millions de dollars et pourra recevoir des paiements d'étape supplémentaires basés sur les ventes et pour un montant de 5 millions de dollars, ainsi que des redevances sur les ventes nettes en Europe. Les autres termes financiers du contrat ne sont pas divulgués.

Voir le communiqué sur http://www.norgine.com

Références  

1. Le kit de préparation radio-pharmaceutique SmPC Lymphoseek 250 microgrammes. Disponible en ligne : http://ec.europa.eu/health/documents/community-register/2014/20141119129982/anx_129982_en.pdf

2. GLOBOCAN 2012 : Estimation de l'incidence du cancer, mortalité et prévalence dans le monde en 2012. Disponible en ligne : http://globocan.iarc.fr/Default.aspx

Contact : Charlotte Andrews, +44(0)7714-061-485

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