{"id":26398,"date":"2022-10-25T03:44:07","date_gmt":"2022-10-25T03:44:07","guid":{"rendered":"https:\/\/d36deud6t4mnhi.cloudfront.net\/press-releases\/declaration-dipsen-concernant-la-nouvelle-date-de-reunion-du-comite-consultatif-de-la-fda-sur-le-palovarotene\/"},"modified":"2024-07-22T12:01:32","modified_gmt":"2024-07-22T10:01:32","slug":"ipsen-statement-on-updated-timeline-for-palovarotene-fda-advisory-committee-meeting","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/fr\/press-releases\/ipsen-statement-on-updated-timeline-for-palovarotene-fda-advisory-committee-meeting\/","title":{"rendered":"D\u00e9claration d\u2019Ipsen concernant la nouvelle date de r\u00e9union du Comit\u00e9 consultatif de la FDA sur le palovarot\u00e8ne"},"content":{"rendered":"\n<p><strong>Paris (France), Le 25 octobre 2022&nbsp;<\/strong>\u2013 Ipsen (Euronext : IPN&nbsp;; ADR&nbsp;: IPSEY) d\u00e9clare que les autorit\u00e9s r\u00e9glementaires am\u00e9ricaines (<em>Food and Drug Administration<\/em>, FDA) ont annonc\u00e9 aujourd\u2019hui leur d\u00e9cision de reporter la r\u00e9union pr\u00e9vue du Comit\u00e9 consultatif sur les traitements des maladies endocriniennes et m\u00e9taboliques concernant le m\u00e9dicament exp\u00e9rimental palovarot\u00e8ne. La nouvelle date sera confirm\u00e9e prochainement. La r\u00e9union du Comit\u00e9 consultatif \u00e9tait initialement pr\u00e9vue le 31 octobre 2022. La FDA a inform\u00e9 Ipsen que le report est li\u00e9 \u00e0 une nouvelle demande d\u2019informations de sa part sur les donn\u00e9es des essais cliniques sur le palovarot\u00e8ne, et ne concerne aucunement le profil de s\u00e9curit\u00e9 du m\u00e9dicament. Ipsen s\u2019emploie actuellement \u00e0 traiter cette demande. D\u00e9termin\u00e9s \u00e0 proposer des options de traitement innovantes \u00e0 la communaut\u00e9 des patients atteints de fibrodysplasie ossifiante progressive, nous travaillerons rapidement avec la FDA pour atteindre au plus vite notre objectif.<\/p>\n\n\n\n<p><strong>\u00c0 propos d\u2019Ipsen&nbsp;<\/strong><\/p>\n\n\n\n<p>Ipsen est une soci\u00e9t\u00e9 biopharmaceutique mondiale de taille moyenne focalis\u00e9e sur la mise au point de m\u00e9dicaments innovants en Oncologie, dans les Maladies rares et en Neurosciences. Avec un chiffre d\u2019affaires de 2,6 milliards d\u2019euros en m\u00e9decine de sp\u00e9cialit\u00e9 pour l\u2019exercice 2021, Ipsen vend des m\u00e9dicaments dans plus de 100 pays. Outre sa strat\u00e9gie d\u2019innovation externe, les efforts d\u2019Ipsen en mati\u00e8re de R&amp;D sont focalis\u00e9s sur ses plateformes technologiques diff\u00e9renci\u00e9es et innovantes situ\u00e9es au c\u0153ur de clusters mondiaux de la recherche biotechnologique ou en sciences de la vie Paris-Saclay, France ; Oxford, Royaume-Uni ; Cambridge, \u00c9tats- Unis ; Shanghai, Chine. Ipsen emploie environ 5 000 collaborateurs dans le monde. Ipsen est cot\u00e9 \u00e0 Paris (Euronext: IPN) et aux \u00c9tats-Unis \u00e0 travers un programme d\u2019<em>American Depositary Receipt<\/em>&nbsp;(ADR&nbsp;: IPSEY) sponsoris\u00e9 de niveau&nbsp;I. Le site Internet d\u2019Ipsen est&nbsp;<a href=\"https:\/\/www.ipsen.com\/\">ipsen.com<\/a>.<\/p>\n\n\n\n<p><strong><u>Pour plus d\u2019informations :<\/u><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Contacts<\/strong><strong>&nbsp;<\/strong><strong><u>Investisseurs<\/u><\/strong><\/td><td><\/td><\/tr><tr><td><strong>&nbsp;Craig&nbsp;Marks<\/strong>Vice-Pr\u00e9sident, Relations Investisseurs+44 (0)7584 349 193<\/td><td><strong>Adrien&nbsp;Dupin de Saint-Cyr<\/strong>Responsable, Relations Investisseurs+33 6 64 26 17 49<\/td><\/tr><tr><td><strong><u>M\u00e9dias<\/u><\/strong><\/td><td><\/td><\/tr><tr><td><strong>Anna Gibbins<\/strong>Directrice Communication Globale Franchise, Maladies Rares+44 7717801900<\/td><td><strong>Rachel Reiff<\/strong>\u00c9TATS-UNIS Directrice Communication Franchise+1 908 616 1680<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Avertissement Ipsen<\/strong><\/p>\n\n\n\n<p>Les d\u00e9clarations prospectives et les objectifs contenus dans cette pr\u00e9sentation sont bas\u00e9s sur la strat\u00e9gie et les hypoth\u00e8ses actuelles de la Direction d\u2019Ipsen. Ces d\u00e9clarations et objectifs d\u00e9pendent de risques connus ou non, et d\u2019\u00e9l\u00e9ments al\u00e9atoires qui peuvent entra\u00eener une divergence significative entre les r\u00e9sultats, performances ou \u00e9v\u00e9nements effectifs et ceux envisag\u00e9s dans ce communiqu\u00e9. Ces risques et \u00e9l\u00e9ments al\u00e9atoires pourraient affecter la capacit\u00e9 d\u2019Ipsen \u00e0 atteindre ses objectifs financiers qui sont bas\u00e9s sur des conditions macro\u00e9conomiques raisonnables, provenant de l\u2019information disponible \u00e0 ce jour. L\u2019utilisation des termes \u2018croit\u2019, \u2018envisage\u2019 et \u2018pr\u00e9voit\u2019 ou d\u2019expressions similaires a pour but d\u2019identifier des d\u00e9clarations pr\u00e9visionnelles, notamment les attentes d\u2019Ipsen quant aux \u00e9v\u00e9nements futurs, y compris les soumissions et d\u00e9cisions r\u00e9glementaires. De plus, les pr\u00e9visions mentionn\u00e9es dans ce document sont \u00e9tablies en dehors d\u2019\u00e9ventuelles op\u00e9rations futures de croissance externe qui pourraient venir modifier ces param\u00e8tres. Ces pr\u00e9visions sont notamment fond\u00e9es sur des donn\u00e9es et hypoth\u00e8ses consid\u00e9r\u00e9es comme raisonnables par Ipsen. et d\u00e9pendent de circonstances ou de faits susceptibles de se produire \u00e0 l\u2019avenir et dont certains \u00e9chappent au contr\u00f4le du Groupe, et non pas exclusivement de donn\u00e9es historiques. Les r\u00e9sultats r\u00e9els pourraient s\u2019av\u00e9rer substantiellement diff\u00e9rents de ces objectifs compte tenu de la mat\u00e9rialisation de certains risques ou incertitudes, et notamment qu\u2019un nouveau m\u00e9dicament peut para\u00eetre prometteur au cours d\u2019une phase pr\u00e9paratoire de d\u00e9veloppement ou apr\u00e8s des essais cliniques, mais n\u2019\u00eatre jamais commercialis\u00e9 ou ne pas atteindre ses objectifs commerciaux, notamment pour des raisons r\u00e9glementaires ou concurrentielles. Ipsen doit faire face ou est susceptible d\u2019avoir \u00e0 faire face \u00e0 la concurrence des m\u00e9dicaments g\u00e9n\u00e9riques qui pourrait se traduire par des pertes de parts de march\u00e9. En outre, le processus de recherche et d\u00e9veloppement comprend plusieurs \u00e9tapes et, lors de chaque \u00e9tape, le risque est important qu\u2019Ipsen ne parvienne pas \u00e0 atteindre ses objectifs et qu\u2019il soit conduit \u00e0 renoncer \u00e0 poursuivre ses efforts sur un m\u00e9dicament dans lequel il a investi des sommes significatives. Aussi, Ipsen ne peut \u00eatre certain que des r\u00e9sultats favorables obtenus lors des essais pr\u00e9 cliniques seront confirm\u00e9s ult\u00e9rieurement lors des essais cliniques ou que les r\u00e9sultats des essais cliniques seront suffisants pour d\u00e9montrer le caract\u00e8re s\u00fbr et efficace du m\u00e9dicament concern\u00e9. Il ne saurait \u00eatre garanti qu\u2019un m\u00e9dicament recevra les homologations n\u00e9cessaires ou qu\u2019il atteindra ses objectifs commerciaux. Les r\u00e9sultats r\u00e9els pourraient \u00eatre sensiblement diff\u00e9rents de ceux annonc\u00e9s dans les d\u00e9clarations pr\u00e9visionnelles si les hypoth\u00e8ses sous-jacentes s\u2019av\u00e8rent inexactes ou si certains risques ou incertitudes se mat\u00e9rialisent. Les autres risques et incertitudes comprennent, sans toutefois s\u2019y limiter, la situation g\u00e9n\u00e9rale du secteur et la concurrence&nbsp;; les facteurs \u00e9conomiques g\u00e9n\u00e9raux, y compris les fluctuations du taux d\u2019int\u00e9r\u00eat et du taux de change&nbsp;; l\u2019incidence de la r\u00e9glementation de l\u2019industrie pharmaceutique et de la l\u00e9gislation en mati\u00e8re de soins de sant\u00e9 ; les tendances mondiales \u00e0 l\u2019\u00e9gard de la ma\u00eetrise des co\u00fbts en mati\u00e8re de soins de sant\u00e9&nbsp;; les avanc\u00e9es technologiques, les nouveaux m\u00e9dicaments et les brevets obtenus par la concurrence&nbsp;; les probl\u00e8mes inh\u00e9rents au d\u00e9veloppement de nouveaux m\u00e9dicaments, notamment l\u2019obtention d\u2019une homologation&nbsp;; la capacit\u00e9 d\u2019Ipsen \u00e0 pr\u00e9voir avec pr\u00e9cision les futures conditions du march\u00e9&nbsp;; les difficult\u00e9s ou d\u00e9lais de production&nbsp;; l\u2019instabilit\u00e9 financi\u00e8re de l\u2019\u00e9conomie internationale et le risque souverain&nbsp;; la d\u00e9pendance \u00e0 l\u2019\u00e9gard de l\u2019efficacit\u00e9 des brevets d\u2019Ipsen et autres protections concernant les m\u00e9dicaments novateurs&nbsp;; et le risque de litiges, notamment des litiges en mati\u00e8re de brevets et\/ou des recours r\u00e9glementaires. Ipsen d\u00e9pend \u00e9galement de tierces parties pour le d\u00e9veloppement et la commercialisation de ses m\u00e9dicaments, qui pourraient potentiellement g\u00e9n\u00e9rer des redevances substantielles ; ces partenaires pourraient agir de telle mani\u00e8re que cela pourrait avoir un impact n\u00e9gatif sur les activit\u00e9s d\u2019Ipsen ainsi que sur ses r\u00e9sultats financiers. Ipsen ne peut \u00eatre certain que ses partenaires tiendront leurs engagements. \u00c0 ce titre, le Groupe pourrait ne pas \u00eatre en mesure de b\u00e9n\u00e9ficier de ces accords. Une d\u00e9faillance d\u2019un des partenaires d\u2019Ipsen pourrait engendrer une baisse impr\u00e9vue de revenus. De telles situations pourraient avoir un impact n\u00e9gatif sur l\u2019activit\u00e9 d\u2019Ipsen, sa situation financi\u00e8re ou ses r\u00e9sultats. Sous r\u00e9serve des dispositions l\u00e9gales en vigueur, Ipsen ne prend aucun engagement de mettre \u00e0 jour ou de r\u00e9viser les d\u00e9clarations prospectives ou objectifs vis\u00e9s dans le pr\u00e9sent communiqu\u00e9 afin de refl\u00e9ter les changements qui interviendraient sur les \u00e9v\u00e9nements, situations, hypoth\u00e8ses ou circonstances sur lesquels ces d\u00e9clarations sont bas\u00e9es. L\u2019activit\u00e9 d\u2019Ipsen est soumise \u00e0 des facteurs de risques qui sont d\u00e9crits dans ses documents d\u2019information enregistr\u00e9s aupr\u00e8s de l\u2019Autorit\u00e9 des March\u00e9s Financiers. Les risques et incertitudes pr\u00e9sent\u00e9s ne sont pas les seuls auxquels Ipsen peut \u00eatre confront\u00e9 et le lecteur est invit\u00e9 \u00e0 prendre connaissance du Document d\u2019enregistrement universel 2021 du Groupe disponible sur son site web&nbsp;<a href=\"https:\/\/www.ipsen.com\/\">www.ipsen.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"template":"","categories":[1233,3563],"tags":[],"class_list":["post-26398","press_release","type-press_release","status-publish","has-post-thumbnail","hentry","category-pressrelease-fr","category-rare-diseases-pressrelease-fr","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>D\u00e9claration d\u2019Ipsen concernant la nouvelle date de r\u00e9union du Comit\u00e9 consultatif de la FDA sur le palovarot\u00e8ne<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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