De Oliveira F.G.,UEG |
Godoi W.M.,Federal University of Goais |
Engenharia Agricola | Year: 2015
Brazil is a country of tropical climate, a fact that hinders the poultry production in the aspect of thermal comfort. Thus, we aimed to evaluate the thermal environment in commercial poultry houses with different covers during the months of December 2012 to May 2013, in the municipality of Rio Verde, Goiás. The experimental design was completely randomized in split plots with factorial arrangement of treatments 2x3, being two shed models (thermal and aluminum roof tiles) and three sections within each shed (initial, central and final) for 182 days, having the days as replicates. The thermal environment was assessed through thermal comfort indices: Temperature and Humidity Index, Black Globe Temperature and Humidity Index, Radiant Heat Load and Enthalpy. The data was analyzed by SISVAR 5.1., through the analysis of variance, the Scott Knott test used to compare the means, considering a significance level of 1%. The results showed a significant statistical difference between the sheds and the points assessed (P < 0.05). The thermal shed had the lowest values for the environmental variables (Dbt and Bgt) and thermal indices studied, but larger values for the RH compared to the shed with aluminum covering. The use of thermal covers minimizes the difference in temperature range throughout various times of the day, being at 14:00 o'clock the prominence time to others.
dos Reis R.C.,IFG |
Devilla I.A.,UEG |
Ascheri D.P.R.,UEG |
Servulo A.C.O.,UEG |
Revista Brasileira de Engenharia Agricola e Ambiental | Year: 2012
The objective of this paper was to model the drying curves of the leaves of basil (Ocimum basilicum L.) in the infrared at temperatures of 50, 60, 70 and 80 °C and to evaluate the influence of drying temperature on the color of dried leaves. Drying was conducted in infrared dryer with temperature and greenhouse air circulation. Experimental data were fitted to eight mathematical models. The magnitude of the coefficient of determination (R2), the mean relative error (P), the estimated mean error (SE) and chisquare test (χ2) were used to verify the degree of fitness of the models. From the study it was concluded that: a) the behavior of the drying curves of basil leaves was similar to most agricultural products, the drying times in the infrared were less than the drying times in an oven with air circulation, b) the mathematical drying model proposed by Midilli et al. (2002) was the one which best adjusted to the experimental data, c) the diffusion coefficient ranged from 9.10 × 10-12 to 2.92 × 10-11 m2 s-1 and d) the color of the samples was highly influenced by drying, becoming darker due to loss of chlorophyll with increasing temperature.
Gomes M.A.,State University of Goiás |
Ascheri D.P.R.,UEG |
De Campos A.J.,UEG
Semina:Ciencias Agrarias | Year: 2016
The market demand for corn starch and cassava continues to increase because of their use in edible applications, their biodegradable nature, and other appealing properties. As a result, there is a need to identify alternative starch sources, for example, the seeds of S. burchelli, with the potential to be modified for use in post-harvest applications. Therefore, this study aimed to develop and characterize edible films based on the starch phosphates of the seeds of S. burchelli, with the specific aim to apply these starches to cherry tomatoes for post-harvest conservation. After extraction, the starch was phosphorylated with sodium tripolyphosphate (STP) in different concentrations and times according to a 2 x 2 factorial design with additional treatment (native starch). After modification, the starch phosphates were selected for the preparation of edible films using glycerol as a plasticizer, in proportions of 5, 10, 15 and 20% for each selected starch. The films were measured for thickness, permeability to water vapor and solubility in water. According to their permeability values, 4 films were selected for application in the coverage of cherry tomatoes. The conservation of cherry tomatoes with and without coverage was studied over 8 evaluation times (up to 21 days) at 10±2 °C and 80±5% relative humidity. The weight loss, soluble solids, titratable acidity, maturation index, and firmness were measured every 3 days during storage. The starch phosphates showed a phosphorus content within that established by standards, such that the resulting films are acceptable for use in food for human consumption. The edible films presented with an acceptable appearance and without the development of cracks. The concentration of glycerol and the type of starch influenced the characteristics of the films, increasing the permeability and reducing the water solubility of the various edible films. The best result obtained regarding the conservation of cherry tomatoes was observed for fruits with edible coatings of greater permeability to water vapor; such fruits exhibited only a slight decline in firmness during storage compared with the control. It can be concluded that the modification performed on the starch and the glycerol concentration positively influenced the properties of the edible films, allowing for optimal use in post-harvest applications. Similarly, the edible coatings conferred better appearance to the fruits, maintaining their maturation index and firmness during the experimental period and providing better post-harvest storage conditions for the cherry tomatoes.
Giongo P.R.,UEG |
Vettorazzi C.A.,University of Sao Paulo
Revista Brasileira de Engenharia Agricola e Ambiental | Year: 2014
This study aimed at to estimate the surface albedo in the Corumbataí River Basin, State of São Paulo, Brazil, using TM-Landsat 5 images, together with the Digital Terrain Model (DTM), in order to take into account the terrain slope, as well as the Mapping Evapotranspiration at High Resolution and with Internalized Calibration (METRIC) model. Available ancillary data from a meteorological station located in the study area, and ten images from 01/02/2009, 04/02/2010, 22/04/2009, 24/05/2009, 12/06/2010, 08/07/2008, 30/07/2010, 31/08/2010, 13/09/2009 and 31/10/2009, were also used. Te use of TM-LANDSAT 5 images with the METRIC model and the DTM, allowed to identify the spatial and temporal variations of different coverages on the mapping of surface albedo of the Corumbataí River Basin. Te data were consistent with those presented in the literature for sugarcane, water, pasture and eucalypt, for satellite images of clear-sky days.
News Article | November 7, 2016
The number of deaths from pancreatic cancer will overtake breast cancer mortality rates in the EU in 2017 (Vienna, 7 November 2016) The number of deaths from pancreatic cancer will overtake breast cancer mortality rates in the EU in 2017, a study has found. The findings, recently presented at UEG Week 2016, mean that pancreatic cancer will become the third leading cause of death from cancer in the EU behind lung and colorectal cancer. Pancreatic cancer mortality rates are increasing in many countries across the EU and it is estimated that 91,500 deaths will occur from the disease next year, compared with 91,000 from breast cancer. The research used time-linear prediction models to estimate mortality rates until 2025, when deaths from pancreatic cancer (111,500) across Europe are projected to have increased by almost 50% since 2010 (76,000)1. All countries included in the study show varying increases in pancreatic cancer mortality rates from 20% to a staggering 131% increase over the 15-year period. Despite being the third biggest cancer killer, the incidence of pancreatic cancer across Europe is relatively low in comparison with colorectal, lung and breast cancer. This demonstrates the extremely poor outlook for patients that are diagnosed with the disease which, unlike many other cancers, has not changed in the last 40 years. Research shows that the median five-year survival rate for pancreatic cancer across Europe is 5% and patients lose 98% of their healthy life expectancy at the point of diagnosis. Despite these alarming statistics, 64% of Europeans state that they know very little about pancreatic cancer and currently there is no feasible screening method. Ahead of World Pancreatic Cancer Day on November 17, experts are calling for increased awareness of the disease to allow patients to be diagnosed in time for life-saving surgery. Professor Matthias Löhr, UEG pancreatic cancer specialist, explains, "Pancreatic cancer survival rate is lower than any other cancer. Consequently, it is absolutely vital that patients receive a diagnosis as early as possible to allow for surgery, which is currently the only potential for a cure". "Members of the public as well as doctors are therefore advised to increase their knowledge of the signs for pancreatic cancer, which include new-onset diabetes, abdominal and back pain, a change in bowel habits and jaundice" adds Professor Löhr. A new video to help increase public awareness of pancreatic cancer is available at: https:/ For further information and interviews with Professor Matthias Löhr, please email email@example.com or call Luke Paskins on 0044 (0)1444 811099 Professor Matthias Löhr is a UEG pancreatic cancer expert from the Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. UEG, or United European Gastroenterology, is a professional non-profit organisation combining all the leading European societies concerned with digestive diseases. Together, its member societies represent over 22,000 specialists, working across medicine, surgery, paediatrics, gastrointestinal oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge. Find out more by visiting http://www. To advance standards of gastroenterological care and knowledge across Europe and the world, UEG offers numerous activities and initiatives, including: 1. Ferlay J., Partensky C., Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. ACTA Oncologica, August 2016. 2. International Agency for Research On Cancer 3. Carrato A., et al. A Systematic Review of the Burden of Pancreatic Cancer in Europe: Real-World Impact on Survival, Quality of Life and Costs. Journal of Gastrointestinal Cancer, May 2014. 4. Ipsos Pancreatic Cancer Awareness Survey: Global Online Omnibus Survey. November 2014.
News Article | December 9, 2016
INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organisation (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab to biosimilar infliximab.1 The ECCO statement covers several aspects related to biosimilars and the key positions are:1 This marks a significant shift in attitude from the previous ECCO position paper, which advised that switching from an established biologic to a biosimilar was inappropriate and called for more data on the safety and benefit of biosimilars in general.2 Professor Silvio Danese, President Elect of ECCO and Head of the IBD Unit, Humanitas Clinical and Research Center, Italy commented: “ Findings from the 2015 ECCO survey of IBD specialists found that around 80% of specialists are either totally confident, very confident or confident enough in using biosimilars, which is a huge change compared to 39% when a similar survey was conducted back in 2013.”3 Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “ This position paper comes amid a global trend encouraging the use of biosimilars. Rising healthcare costs and the consequent financial burden placed on health services are some of the biggest challenges many countries face. While biologics have positively impacted patient treatment, their high costs may limit patient access to these modern medicines. The availability of generally less expensive treatment options like biosimilars can reduce pressure on healthcare system resources. Biosimilars are a cost effective alternative to biological therapies and can eventually lead to potential budget savings and provide improved access to life-changing treatment for patients.” Celltrion Healthcare has already seen success with CT-P13 - the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The recently released NOR-SWITCH study revealed that efficacy and safety were maintained in patients switched to CT-P13 from originator infliximab and it is not inferior to those who continued treatment with the originator.4 These findings were presented at the 2016 United European Gastroenterology (UEG) Week in October and at the 2016 American College of Rheumatology (ACR) Annual Meeting in November. The European Crohn´s Colitis Organisation (ECCO) is the non-profit association founded in 2001 to improve the care of patients with inflammatory bowel disease (IBD) in Europe. ECCO is the largest forum for specialists in IBD in the world, representing 3,132 IBD experts as individual members. ECCO develops clinical guidelines that serve as standard references for IBD management in Europe. The first position statement of ECCO on the use of biosimilar medicines in the treatment of IBD was published in 2013 to define the collective view of European specialist in IBD concerning biosimilars. The biosimilar infliximab developed and manufactured by Celltrion, Inc. was the world’s first biosimilar monoclonal antibody to be 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 biosimilar infliximab in April 2016 under the trade name Inflectra™. Celltrion’s biosimilar infliximab is approved in more than 75 (as of September 20, 2016) countries including the US, Canada, Japan and throughout Europe. Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about five people per 1,000.5 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6 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/ 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337.
News Article | December 9, 2016
" Questo documento di sintesi si inserisce in un contesto globale che tende a incoraggiare l'uso dei biosimilari. I crescenti costi dell'assistenza sanitaria e il conseguente onere finanziario per i servizi sanitari sono alcuni dei problemi più importanti che molti paesi devono affrontare. I biologici hanno influito positivamente sul trattamento dei pazienti, ma i loro costi elevati possono limitare l'accesso a questi farmaci moderni. La disponibilità di opzioni di trattamento generalmente meno costose, come i biosimilari, può ridurre la pressione sulle risorse dei sistemi sanitari", ha dichiarato Man Hoon Kim, Presidente e CEO di Celltrion Healthcare. Celltrion Healthcare ha già ottenuto risultati positivi con CT-P13, il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA) e dalla Food and Drug Administration (FDA) statunitense. I dati dello studio clinico NOR-SWITCH recentemente divulgati hanno evidenziato che l'efficacia e la sicurezza restavano invariate nei pazienti passati al trattamento con CT-P13 da infliximab originale, e che tali valori non erano inferiori rispetto ai pazienti che proseguivano con il trattamento a base del prodotto originale.4 Questi risultati sono stati presentati alla 2016 United European Gastroenterology (UEG) Week nel mese di ottobre e al convegno annuale 2016 dell'American College of Rheumatology (ACR) a novembre. La European Crohn´s Colitis Organisation (ECCO) è l'associazione non a scopo di lucro fondata nel 2001 per migliorare il trattamento dei pazienti affetti da malattia infiammatoria intestinale (IBD) in Europa. ECCO è il maggior forum per gli specialisti nelle IBD a livello mondiale, in rappresentanza di 3.132 esperti IBD in qualità di singoli associati. ECCO sviluppa direttive cliniche che fungono da riferimenti standard per la gestione delle IBD in Europa. La prima presa di posizione di ECCO sull'uso dei biosimilari nel trattamento delle IBD è stato pubblicato nel 2013 per definire la visione collettiva degli specialisti europei in materia di biosimilari per il trattamento delle IBD. Il biosimilare infliximab 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 il biosimilare infliximab di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. Il biosimilare infliximab di Celltron è approvato in oltre 75 paesi (dati aggiornati al 20 settembre 2016), inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. Le IBD rappresentano un aggravio importante per il sistema sanitario e per la società, con costi diretti calcolati in 4,6-5,6 miliardi di euro all'anno.6 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 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337.
Le nouveau rapport de l'Organisation Europeenne de la Maladie de Crohn et de la Colite encourage la transition du produit de reference vers le biosimilaire dans le traitement des maladies inflammatoires de lintestin
News Article | December 10, 2016
Cette décision est un changement important par rapport à l’énoncé de position précédent de l’ECCO, selon lequel la transition d’un produit biologique établi vers un biosimilaire serait inapproprié et demanderait plus de données sur l’innocuité et les avantages des biosimilaires en général.2 Celltrion Healthcare a déjà rencontré du succès avec le CT-P13, le premier anticorps monoclonal biosimilaire au monde approuvé par l’Agence européenne des médicaments (EMA) et par la Food and Drug Administration (FDA) américaine. Les résultats récemment publiés de l’étude NOR-SWITCH ont révélé que les niveaux d’efficacité et d’innocuité étaient maintenus chez les patients qui sont passés de l’infliximab princeps au CT-P13, et qu’ils ne sont pas inférieurs à ceux des patients ayant continué le traitement avec le princeps.4 Ces résultats ont été présentés précédemment lors de la 2016 United European Gastroenterology (UEG) Week, au mois d’octobre et au congrès annuel de l’American College of Rheumatology (ACR) en novembre 2016. L'Organisation Européenne de la Maladie de Crohn et de la Colite (European Crohn’s and Colitis Organisation, ECCO), fondée en 2001 pour améliorer les soins des patients souffrant de maladie inflammatoire des intestins (IBS) en Europe est maintenant le forum le plus entendu pour les spécialistes de IBS dans le monde. Il est composé de 3 132 experts des MII qui sont des membres individuels. ECCO développe des directives cliniques qui servent de normes de référence pour la gestion des MII en Europe. Le premier énoncé de position d’ECCO relatif à l’utilisation des médicaments biosimilaires dans le cadre du traitement des MII a été publié en 2013 afin de définir l’opinion collective des spécialistes européens en ce qui concerne les biosimilaires et le traitement des MII. 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 75 pays (au 20 septembre 2016), y compris les États-Unis, le Canada, le Japon et dans toute l’Europe. Celltrion Healthcare se charge de la commercialisation, la vente et la distribution de médicaments biologiques mis au point par Celltrion, Inc. à travers un réseau mondial couvrant plus de 120 pays. Les produits de Celltrion Healthcare sont fabriqués dans des installations de pointe destinées à la culture de cellules de mammifères et conformes aux normes de bonnes pratiques de fabrication de la FDA américaine et de l’EMA. Pour de plus amples informations, visitez le site : http://www.celltrionhealthcare.com/ 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337.
News Article | December 10, 2016
INCHEON, Zuid-Korea--(BUSINESS WIRE)--Celltrion Healthcare is verheugd over de publicatie van de meest recente position paper van de Europese organisatie voor Crohn en Colitis (ECCO) over het gebruik van biosimilars voor inflammatoire darmaandoeningen (IBD). De position paper ondersteunt de overstap van het referentieproduct infliximab naar biosimilar infliximab.1 Dit markeert een belangrijke verandering in de houding ten opzichte van de vorige position paper van ECCO. Daarin werd gewaarschuwd dat de overstap van een gevestigd biologisch middel naar een biosimilar ongepast was en werd gepleit voor meer gegevens over de veiligheid en het voordeel van biosimilars in het algemeen.2 Professor Silvio Danese, President Elect van ECCO en hoofd van de IBD Unit, Humanitas Clinical and Research Center, Italië, merkte op: “ Uit de bevindingen van het ECCO-onderzoek van 2015 van de IBD-specialisten bleek dat ongeveer 80% van de specialisten ofwel helemaal zeker zijn van, ofwel veel vertrouwen of genoeg vertrouwen hebben in het gebruik van biosimilars. Dat is een enorme verandering in vergelijking met de 39% toen een vergelijkbaar onderzoek werd uitgevoerd in 2013.”3 Celltrion Healthcare heeft al succes ondervonden met CT-P13, 's werelds eerste monoklonaal antilichaam-biosimilar die goedgekeurd is door het Europees Geneesmiddelenbureau (EMA) en de Amerikaanse Food and Drug Administration (FDA). Uit de onlangs gepubliceerde NOR-SWITCH-studie is gebleken dat de werkzaamheid en veiligheid gehandhaafd bleven bij patiënten die de overstap hadden gemaakt van originator infliximab naar CT-P13 en dat deze niet onderdeden voor de gegevens van degenen die de behandeling met de originator voortzetten.4 Deze bevindingen werden gepresenteerd tijdens de 2016 United European Gastroenterology ( UEG) Week in oktober en op de jaarvergadering van 2016 van het American College of Rheumatology (ACR) in november. De Europese organisatie voor Crohn en Colitis (ECCO) is de non-profit organisatie opgericht in 2001 om de zorg voor patiënten met inflammatoire darmziekten (IBD) in Europa te verbeteren. ECCO is het grootste forum voor specialisten op het gebied van IBD ter wereld, dat 3132 IBD-deskundigen vertegenwoordigt als individuele leden. ECCO ontwikkelt klinische richtlijnen die dienen als standaard referenties voor het beheer van IBD in Europa. De eerste standpuntverklaring van ECCO over het gebruik van biosimilars bij de behandeling van IBD werd gepubliceerd in 2013 om de collectieve zienswijze van de Europese specialisten op het gebied van IBD met betrekking tot biosimilars te bepalen. De biosimilar infliximab, ontwikkeld en geproduceerd door Celltrion, Inc., was 's werelds eerste biosimilar monoklonale antilichaam 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 door de EMA goedgekeurd onder de handelsnaam Remsima® en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's biosimilar infliximab goed in april 2016 onder de merknaam Inflectra™. Celltrion's biosimilar infliximab is goedgekeurd in meer dan 75 (vanaf 20 september 2016) landen, waaronder de VS, Canada, Japan en heel Europa. Inflammatoire darmziekten (IBD), waaronder de ziekte van Crohn (CD) en colitis ulcerosa (UC), zijn chronische invaliderende gastrointestinale aandoeningen die van invloed zijn op het gehele leven van een patiënt.5 Ongeveer 2,5 - 3 miljoen mensen in Europa worden er door getroffen;6 CD treft ongeveer drie personen per 1000 en UC ongeveer vijf personen per 1000.5 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/ 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337. 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 | October 27, 2016
Webcast presentation tomorrow 28 October at 14.00 CET/8 AM ET, www.glpg.com , +32 2 400 6926, code 2352766 Mechelen, Belgium, Oct. 27, 2016 (GLOBE NEWSWIRE) -- Galapagos NV (Euronext & NASDAQ: GLPG) announces significant progress in R&D in the first nine months while reporting financial results in line with management guidance. These unaudited results of the first nine months are further detailed in an online Q3 2016 Report published on the Galapagos website, www.glpg.com . "This quarter, we are again encouraged by the progress made in our R&D programs. The FINCH Phase 3 program in RA is recruiting. By year end, Gilead is expected to have in total three major late stage clinical programs dosing patients with filgotinib, with more Phase 2 studies targeting other inflammatory diseases expected in 2017. The endoscopy and histopathology data reported from the FITZROY study with filgotinib in Crohn's disease at UEG Week set a high bar for Crohn's clinical research going forward. We are excited about the progress made in our cystic fibrosis program, keeping us on track to potentially have a triple combination therapy in Class II patient studies by mid-year 2017," said Onno van de Stolpe, CEO. "In the background, our research teams continue to discover new targets and molecules, propelling them forward toward patients, as we go for our ambitious goal of delivering three novel target based Proofs-of-Concept in patients every year." "The financial results for the first nine months of 2016 were fully in line with our expectations, leaving us with a solid cash position of €939 million on 30 September. Our revenues increased by 38% compared to the same period in 2015. We reiterate our cash burn guidance for the full year within the range of €100-120 million, excluding payments from Gilead for filgotinib," said Bart Filius, CFO. Notes: 1) reflects non-cash financial asset adjustment resulting from the Gilead subscription agreement, which offsets the negative €30.6 million non-cash adjustment booked in Q4 2015 2) including €7.9 million of restricted cash 3) including €8.0 million of restricted cash Q3 Report 2016 A detailed Q3 Report for 2016 is available at www.glpg.com/financial-reports. Printed versions of the report can be requested via firstname.lastname@example.org. Conference call and webcast presentation Galapagos will conduct a conference call open to the public tomorrow (28 October 2016) at 14:00 Central European Time (CET), which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement: A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call. About Galapagos Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, 2, 1, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 480 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com. Forward-looking statements This release may contain forward-looking statements, including, among other things, statements regarding the guidance from management (including guidance regarding the expected cash burn during financial year 2016), financial results, timing and/or results of clinical trials, and interaction with regulators. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Galapagos' expectations regarding its 2016 revenues and financial results and 2016 operating expenses may be incorrect (including because one or more of its assumptions underlying its revenue or expense expectations may not be realized), Galapagos' expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos' ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties, and estimating the commercial potential of its development programs. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.