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À la suite des présentations lors de la United European Gastroenterology (UEG) Week 2016 et de la réunion annuelle de l'American College of Rheumatology (ACR), les résultats de l'étude ont révélé que sur les 50 % de patients qui étaient passé au CT-P13, la proportion de patients dont la maladie progressait était comparable à celle des patients demeurés sous l'infliximab de référence (respectivement 29,6 et 26,2 %). Les taux d'abandon dû au manque d'efficacité pour l'infliximab de référence et l'infliximab biosimilaire étaient respectivement de huit et trois. La durée avant abandon du traitement objet de l'étude était quasiment identique entre les deux groupes, et des taux de rémission globaux et fréquences d'effets indésirables analogues ont également été observés. 1 Tore K. Kvien, chef du service de rhumatologie de l'hôpital Diakonhjemmet à Oslo, en Norvège, et auteur principal de l'étude NOR-SWITCH, a aussi déclaré: « Les résultats de NOR-SWITCH montrent que l'efficacité et l'innocuité sont comparables chez les patients passés au CT-P13 et ceux qui ont poursuivi leur traitement à l'aide de l'infliximab de référence, ce qui prouve que les patients peuvent passer au CT-P13 en toute sécurité. Comme les données concernent spécifiquement le CT-P13, il convient d'indiquer clairement que ces résultats ne peuvent s'appliquer qu'à ce biosimilaire particulier.» Menée auprès de près de 500 patients, l'étude a été conçue par un groupe de projet pluridisciplinaire et plurirégional possédant des compétences spéciales dans les domaines des essais stratégiques, de l'immunogénicité et des statistiques et dirigé par le professeur Tore Kvien au service de rhumatologie de l'hôpital de Diakonhjemmet à Oslo, en Norvège. Le groupe comprenait en outre des représentants des trois organisations de patients pertinentes.2 Le CT-P13 est développé et fabriqué par Celltrion, Inc. et a été le premier anticorps monoclonal biosimilaire approuvé par l’Agence européenne des médicaments (EMA). Il est indiqué pour le traitement de huit maladies auto-immunes, notamment la polyarthrite rhumatoïde et les maladies inflammatoires de l’intestin. Le CT-P13 a été approuvé par l’EMA sous le nom commercial Remsima® en septembre 2013 et lancé en Europe début 2015. La FDA a approuvé le CT-P13 de Celltrion en avril 2016 sous le nom commercial Inflectra™. Le CT-P13 de Celltrion est approuvé dans plus de 79 pays (au mois de janvier 2017), y compris les États-Unis, le Canada, le Japon et dans toute l’Europe. Celltrion Healthcare assure la commercialisation, la vente et la distribution dans le monde entier des médicaments biologiques mis au point par Celltrion, Inc. grâce à un vaste réseau mondial couvrant plus de 120 pays. Les produits de Celltrion Healthcare sont fabriqués dans des installations de culture de cellules de mammifères de pointe, conçues et construites conformément aux bonnes pratiques de fabrication de la Food and Drug Administration (FDA) américaine et de l'Union européenne. Pour de plus amples informations, consultez: http://www.celltrionhealthcare.com/ The Lancet est l'une des plus importante revue médicale générale indépendante du monde. Cette revue révisée par des pairs publie des actualités médicales, des recherches originales et des comptes rendus sur tous les aspects de la médecine clinique et de la santé internationale. The Lancet a un facteur d'impact de 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, disponible à l'adresse suivante: http://dx.doi.org/10,1016/S0140-6736(17)30068-5 [consulté en mai 2017].


Dr Kwon, medisch directeur bij Celltrion Healthcare, verklaarde: “ De publicatie van de NOR-SWITCH-gegevens in The Lancet markeert opnieuw een belangrijke mijlpaal voor het vergroten van het vertrouwen van artsen om biosimilar infliximab te gebruiken als overwogen wordt om hun patiënten over te schakelen.” Na presentaties tijdens zowel de 2016 United European Gastroenterology (UEG) Week als de jaarlijkse bijeenkomst van het American College of Rheumatology (ACR) bleek uit de bevindingen van de studie dat van de 50% van de patiënten die overgeschakeld waren naar CT-P13, het percentage patiënten met verslechtering van de ziekte vergelijkbaar was met die patiënten die referentie infliximab bleven gebruiken (respectievelijk 29,6 en 26,2%). De datadiscontinueringspercentages door een gebrek aan werkzaamheid voor referentie infliximab en biosimilar infliximab waren respectievelijk acht en drie. De tijd om de stopzetting van de medicijnen te onderzoeken was bijna identiek tussen de twee groepen, waarbij ook vergelijkbare totale remissiecijfers en frequenties van bijwerkingen waargenomen werden. 1 CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ The Lancet is een van 's werelds grootste onafhankelijke algemene medische tijdschriften. Het intercollegiaal getoetste tijdschrift publiceert medisch nieuws en origineel onderzoek en biedt evaluaties over alle aspecten van klinische geneeskunde en internationale gezondheid. The Lancet heeft een impactfactor van 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, beschikbaar op: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [geraadpleegd in mei 2017]. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


News Article | May 12, 2017
Site: www.businesswire.com

INCHEON, South Korea--(BUSINESS WIRE)--Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima®/ Inflectra™) were published in the prestigious journal The Lancet. Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. 1 Dr Kwon, Medical Director at Celltrion Healthcare said: “ The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.” Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. 1 Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “ NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.” The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis). Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.2 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017]. 2 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].


Sponsorizzato dal governo norvegese, lo studio ha esplorato l’impatto del passaggio al biosimilare infliximab CT-P13 di Celltrion Healthcare nei pazienti adulti in condizioni stabili trattati con il prodotto originale infliximab. I dati dimostrano che CT-P13 non è inferiore al trattamento continuativo con infliximab originale e che i pazienti possono passare da una terapia all'altra in tutta sicurezza. 1 A seguito di presentazioni tenutesi in occasione della 2016 United European Gastroenterology (UEG) Week e dell’incontro annuale dell’American College of Rheumatology (ACR), i dati dello studio hanno rivelato che nel 50% di pazienti passati a CT-P13, la proporzione di pazienti che hanno dimostrato un peggioramento della malattia era paragonabile a quelli che continuavano ad essere trattati con infliximab originale (29,6 e 26,2%, rispettivamente). I tassi di sospensione dei dati dovuta ad una mancanza di efficacia per infliximab orginale e infliximab biosimilare erano pari a otto e tre, rispettivamente. È risultato inoltre che il tempo necessario per studiare la sospensione del farmaco sperimentale era quasi identico per entrambi i gruppi, con simili tassi di remissione e frequenza di eventi avversi complessivi. 1 Il Professor Tore Kvien, responsabile del dipartimento di reumatologia del Diakonhjemmet Hospital di Oslo, in Norvegia, e responsabile dello studio NOR-SWITCH, ha inoltre dichiarato: “ I risultati di NOR-SWITCH mostrano che la sicurezza e l’efficacia erano paragonabili fra pazienti che sono passati a CT-P13 e quelli che continuavano il trattamento con infliximab originale, provando che i pazienti possono passare a CT-P13 in tutta sicurezza. Va tuttavia ricordato che questi dati si riferiscono specificamente a CT-P13 e non sono trasferibili ad altri biosimilari”. Per determinare l’impatto del passaggio al biosimilare infliximab (CT-P13) nei pazienti adulti in condizioni stabili precedentemente trattati con il prodotto originale, il governo norvegese ha finanziato lo studio NOR-SWITCH per valutare questa opzione in tutte le patologie infiammatorie per le quali infliximab è approvato (morbo di Crohn, colite ulcerativa, artrite reumatoide, spondiloartrite, artrite psoriasica o psoriasi cronica a placche). CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito http://www.celltrionhealthcare.com/ 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Disponibile su: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [ultimo accesso maggio 2017].


Dixon|James Communications has spun off its growing rebranding specialty team into a separate entity - The Rebranding Experts - allowing it to more directly market its services to those companies and organizations interested in a rebranding business strategy to accelerate growth. The specialty team was launched in 2012 with the rebranding of The British Home as Cantata Adult Life Services and has supported multiple rebrandings since. The team just assisted electronics repair company UEG to rebrand as ReUp as it grows from a business-to-business focus to add direct-to-consumer repair and trade-in service via http://www.reupdevices.com. “We have seen a steady increase in companies and organizations using rebranding to strategically overcome brand limitations and transform for the future,” says Jim Heininger, firm founder. “To meet that need we've moved this capability out from under the agency’s umbrella with its own dedicated storefront and website http://www.rebrandingexperts.com. The key to The Rebranding Experts' success has been assembling a team with the skills in branding, marketing, design, communications, change and project management to seamlessly lead the rebranding process from sell-in to launch to full-scale marketing.” The Rebranding Experts (http://www.rebrandingexperts.com) support simple brand refreshes of logo and graphic identify to full-scale renaming of organizations complete with new mission and vision statements. The firm utilizes a proprietary methodology and full suite of services including: building a rebranding business case, new brand strategy, creative logo and identify development, tagline creation, stakeholder and market research, customer experience design, leadership and employee communications/engagement, special launch events, website redesign and digital marketing, marketing and communications to impacted stakeholders and change management to facilitate the necessary business transformation. The Rebranding Experts will utilize service specialties of the Dixon|James team as needed to scale client projects. Founder Jim Heininger, a marketing communications veteran with 30 years’ experience at McDonald’s Corporation and agencies Ogilvy, Ketchum and Porter Novelli, will oversee both operations. Based in Chicago, Dixon|James (http://www.dixon-james.com) will continue to focus on delivering growth communications for clients, including branding, marketing communications, employee engagement/change management, public relations and digital/social marketing.


1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, del 6 al 9 de mayo de 2017 2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, del 6 al 9 de mayo de 2017 3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, del 6 al 9 de mayo de 2017 4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219 5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416 6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(Suppl1): A589-A590 8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Acceso 25 de abril de 2017]


Norgine B.V. today presented new post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of PLENVU®, a low volume, 1 litre PEG and ascorbate bowel preparation when compared to sodium picosulfate with magnesium citrate (CITRAFLEET®) and 2 litre PEG with ascorbate (MOVIPREP®) respectively when using site colonoscopist assessments.[1],[2] In addition, data from the DAYB study show that PLENVU® achieved statistically significant improvements in adequate cleansing rates using the Boston Bowel Preparation Score when compared to sodium picosulfate with magnesium citrate.[3] Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate; PLENVU® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.[4],[5],[6] Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented "These phase III data confirm the potential of PLENVU®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources." These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago. The PLENVU® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB. Colorectal cancer is the second most common cause of cancer-related mortality in Europe and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.[7],[8] PLENVU® data being presented at DDW on Saturday 6 May, 12:00 CDT In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU® in the US and Canada. PLENVU® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US. 1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017 2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017 3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017 4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219 5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416 6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(Suppl1): A589-A590 8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]


Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate; PLENVU® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.[4],[5],[6] Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented "These phase III data confirm the potential of PLENVU®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources." These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago. The PLENVU® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB. Colorectal cancer is the second most common cause of cancer-related mortality in Europe and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.[7],[8] PLENVU® data being presented at DDW on Saturday 6 May, 12:00 CDT In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU® in the US and Canada. PLENVU® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US. 1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017 2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017 3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017 4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219 5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416 6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(Suppl1): A589-A590 8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]


Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate; PLENVU® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.[4],[5],[6] Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented "These phase III data confirm the potential of PLENVU®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources." These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago. The PLENVU® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB. Colorectal cancer is the second most common cause of cancer-related mortality in Europe and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.[7],[8] PLENVU® data being presented at DDW on Saturday 6 May, 12:00 CDT In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU® in the US and Canada. PLENVU® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US. 1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017 2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017 3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017 4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219 5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416 6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(Suppl1): A589-A590 8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]


Le Dr Alastair Benbow, directeur médical et du développement chez Norgine, a déclaré : « Ces données de phase III confirment le potentiel de PLENVU®, une préparation intestinale de faible volume visant à remplacer les préparations intestinales conventionnelles. La coloscopie étant considérée comme l'une des procédures de dépistage du cancer colorectal les plus efficaces, utiliser une préparation intestinale hautement efficace telle que PLENVU® est important pour permettre une meilleure détection des adénomes et des polypes, ce qui améliorera au final les résultats thérapeutiques des patients et économisera les ressources des systèmes de santé. » Le cancer colorectal est la deuxième cause la plus courante de mortalité liée au cancer en Europe et aux États-Unis, avec 412 000 nouveaux diagnostics de cancer colorectal chaque année en Europe et 136 115 aux États-Unis.[7],[8] 1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. (Qualité de la préparation intestinale NER1006 par rapport à une préparation à base de picosulfate de sodium et de citrate de magnésium, évaluée par des médecins gastroentérologues sur site : une analyse post-hoc d'un essai contrôlé randomisé) Sa1109. Semaine des maladies digestives, du 6 au 9 mai 2017 2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. (Qualité de la préparation intestinale NER1006 par rapport à une préparation standard associant 2 L de PEG à de l'ascorbate, évaluée par des médecins gastroentérologues sur site : une analyse post-hoc d'un essai contrôlé randomisé) Sa1096. Semaine des maladies digestives, du 6 au 9 mai 2017 3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. (Obtenir une préparation intestinale de niveau adéquat avec un dosage la veille de NER1006 par rapport à du picosulfate de sodium associé à du citrate de magnésium : analyse post-hoc d'un essai de phase 3.) Sa1120. Semaine des maladies digestives, du 6 au 9 mai 2017 4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. (Efficacité et innocuité de la nouvelle préparation intestinale associant 1 L de PEG à de l'ascorbate NER1006 comparativement à une solution standard de 2 L de PEG avec de l'ascorbate dans le cadre de l'administration de doses fractionnées du jour au lendemain ou le matin : résultats de l'étude de phase 3 MORA.) UEG Journal 2016 ; 4(Suppl1) : A218 - A219 5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. (Efficacité et innocuité de la nouvelle préparation intestinale associant 1 L de PEG à de l'ascorbate NER1006 comparativement à une solution à base de trisulfate dans le cadre de l'administration de doses fractionnées pendant la nuit : résultats de l'étude de phase 3 NOCT.) UEG Journal 2016 ; 4(Suppl1) : A415-A416 6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB. (Efficacité et innocuité de la nouvelle préparation intestinale associant 1 L de PEG à de l'ascorbate NER1006 comparativement à une solution à base de picosulfate de sodium et de citrate de magnésium dans le cadre de l'administration de doses fractionnées prises la veille : résultats de l'étude de phase 3 DAYB.)  UEG Journal 2016 ; 4(Suppl1) : A589-A590

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