Celltrion Healthcare Present 1-year Results for CT-P13 (Biosimilar Infliximab, Remsima®/ Inflectra®) Switching Study in Crohn’s Disease
Today at the 25th United European Gastroenterology Week Congress, Celltrion Healthcare presented data from the phase III, randomised controlled, switching trial comparing CT-P13 and reference infliximab. The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.1
The trial investigated the efficacy and safety of CT-P13 throughout a 54-week treatment period, following a switch from reference infliximab at week 30. 220 patients were randomly assigned to four groups (maintained groups [CT-P13 and reference infliximab] and switched groups [reference infliximab to CT-P13 and CT-P13 to reference infliximab]) in a double-blinded manner. Efficacy, pharmacokinetics (PK) and safety were comparable among all treatment groups up to week 30.2 The Crohn’s Disease Activity Index - 70 (CDAI-70) response, clinical remission and the Short Inflammatory Bowel Disease questionnaire (SIBDQ) score, a measure of quality of life for people with inflammatory bowel disease, were similar among all groups at each measured time point up to week 54 too.1
The safety profiles among all treatment groups, including adverse reactions, serious adverse events, infections, and immunogenicity were similar throughout the one year treatment period.1
Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany, commented on the study, “This is the next randomised controlled trial following the NOR-SWITCH study in patients with inflammatory bowel disease using CT-P13 infliximab that shows positive results. All treatment groups in this study, including reference infliximab maintenance, CT-P13 infliximab maintenance, and switching in both directions (reference to CT-P13 and CT-P13 to reference) groups showed comparable efficacy and safety. As a gastroenterologist, I find these data reassuring and hope they help my fellow physicians make informed treatment decisions to ensure the best outcomes for their patients.”
Improving patient treatment experience of CT-P13
Celltrion Healthcare also presented data from an initial phase I open label study of a subcutaneous (SC) form of CT-P13 in healthy volunteers. The study was designed to evaluate the safety and PK of CT-P13 SC. Results showed PK profiles after a single SC injection were linear by dose levels. Subcutaneous administration of CT-P13 was found to be feasible in terms of bioavailability and safety profile and could provide patients with a more convenient and accessible treatment administration option.3
Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “Active switching to biosimilars could have a significant impact on the financial sustainability of healthcare systems by generating budget savings for biologic treatments. This switching study in Crohn’s disease is important in showing clinical evidence of the comparable safety and efficacy when switching to biosimilars. Adding to the wealth of data for CT-P13, Celltrion Healthcare is confident that these results should help physicians to feel even more confident in switching between reference products and biosimilars and is committed to continuously providing more convenient treatment options, including the subcutaneous form of infliximab to patients.”
Notes to editors:
About inflammatory bowel disease
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.4 They affect an estimated 2.5-3 million people in Europe;5 CD affects about three people per 1,000 and UC about 5 people per 1,000.4
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.5
About Celltrion Healthcare
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/.
About CT-P13 3.4 CD RCT
The study is a randomised, double-blind, parallel-group, phase III study to investigate the efficacy and safety of CT-P13 compared to reference infliximab in people with Crohn’s disease. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis and 180 patients completed up to week 30. At week 30 approximately half of the patients in each group were switched to the alternative treatment up to 54 weeks. 166 patients completed the study to 54 weeks. The study was funded equally by Celltrion and Pfizer.
About CT-P13 (biosimilar infliximab)
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 IBD. 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 CT-P13 in April 2016 under the trade name Inflectra™. CT-P13 is approved in more than 80 countries (as of October 2017) including the US, Canada, Japan and throughout Europe.
1 Kim YH, et al. LB04, Phase III randomized controlled
trial to compare biosimilar infliximab (CT-P13) with innovator
infliximab in patients with active Crohn’s disease: 1-year maintenance
and switching results. Presented at the 25th United European
Gastroenterology Week Congress.
2 Kim YH, et al. Phase III randomized double-blinded, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab (INX) in patients with active Crohn’s disease: early efficacy and safety results. Gastroenterology 152, S65 (2017).
3 R. Westhovens et al . P0387, Subcutaneous administration of a novel formulation of CT-P13 (Infliximab biosimilar) is safe and achieves projected therapeutic drug levels: a phase Ⅰ study in healthy subjects, Presented at the 25th United European Gastroenterology Week Congress.
4 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017].
5 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Lehman Brothers Treasury to Further Explore Strategic Opportunities15.10.2018 19:54 | Tiedote
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that the liquidators of LBT are continuing to explore various strategies to, among other things, facilitate the consolidation of the LBT creditor base and the wind-down of the LBT estate. To that end, the liquidators of LBT intend to engage with certain of LBT’s creditors and other market participants regarding potential strategies, including, but not limited to, a potential sale of a portion of LBT’s assets. No assurances can be made that any strategy will be employed, or if one is employed, the timing of its implementation. LBT does not undertake to publicly update its disclosure to reflect developments in this matter. View source version on businesswire.com: https://www.businesswire.com/news/home/20181015005777/en/ Contact information Kramer Levin Naftalis & Frankel LLP Daniel Eggermann, 212-715-9495
SFL – Third-Quarter 2018 Financial Information15.10.2018 19:28 | Tiedote
Regulatory News: SFL (Paris:FLY): Consolidated revenue by business segment (€000's) 2018 (9 months) 2017 (9 months) Rental income 143,790 147,819 o/w Paris Central Business District 119,038 114,326 Paris Other 22,479 21,526 Western Crescent 2,273 11,967 Other revenue 0 0 Total consolidated revenue 143,790 147,819 At €143.8 million, consolidated rental income for the first nine months of 2018 was down €4.0 million or 2.7% compared to the €147.8 million reported for the same period of 2017. The decline was due to the disposal of the IN/OUT property in September 2017, the effects of which were offset to a significant extent by growth in like-for-like income. On a like-for-like basis (excluding all changes in the portfolio affecting period-on-period comparisons), rental income was €6.0 million (4.6%) higher, reflecting the contribution of new leases signed in 2017 and 2018, mainly in the Washington Plaza, 103 Grenelle, Cézanne Saint-Honoré and 9 Percier properties, as well as an increase i
Hilton Earns #2 Spot as World’s Best Workplace15.10.2018 18:54 | Tiedote
For the third consecutive year, Hilton has been named as one of the World’s Best Workplaces recognized by Great Place to Work®. Hilton climbed seven spots to the highly coveted second spot on the list of the top 25 companies and is the only hospitality company in the top ten. Team Members from the world’s most hospitable company say Hilton’s culture, benefits and travel perks make it a great place for a career. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005711/en/ Hilton President & CEO Chris Nassetta with Team Members. (Photo: Business Wire) “Our Team Members are the heart of our business, and they have been the driving force behind our growth and success around the world for nearly 100 years,” said Christopher J. Nassetta, president & CEO of Hilton. “As the pioneers of hospitality, we are dedicated to creating exceptional experiences for every person we meet - and this starts with our Team Members, who make all o
IDEMIA Appoints Yann Delabrière as Group CEO15.10.2018 17:53 | Tiedote
The supervisory board of IDEMIA, the global leader in Augmented Identity, has appointed Yann Delabrière to be Chief Executive Officer with immediate effect taking over from Didier Lamouche who has resigned. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005635/en/ Yann Delabrière (credit Pierre Charriau/IDEMIA) One year after the successful coming together of Oberthur Technologies (OT) and Safran I&S (Morpho) that gave rise to IDEMIA, Yann Delabrière will be charged with overseeing a new phase in the Group’s growth. Yann Delabrière, who previously served as CEO of Faurecia followed by CEO of Zodiac Aerospace, was appointed IDEMIA’s supervisory board chairman in January 2018. Since then he has gained in-depth understanding of the Company’s operations and people. IDEMIA will now look to benefit from Yann’s extensive international managerial experience. Yann Delabrière stated: “I am delighted that the Supervisory Board is
9 in 10 Enterprises Report Gaps Between the Cybersecurity Culture They Have and the One They Want15.10.2018 16:35 | Tiedote
With cybersecurity threats continuing to escalate worldwide, the ISACA/CMMI Institute Cybersecurity Culture Report found that just 5 percent of employees think their organization’s cybersecurity culture is as advanced as it needs to be to protect their business from internal and external threats. More than 4,800 business and technology professionals shared their insights in the global research study, conducted via online polling in June 2018. Results were released today at ISACA’s CSX North America cybersecurity conference in Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005149/en/ New global research from ISACA and the CMMI Institute shows 95% of organizations say there is a gap between the cybersecurity cultures they have and the ones they want. (Graphic: Business Wire) Cybersecurity culture is a workplace culture in which security awareness and behaviors are integrated into everyone’s daily operations, a
AirFit F30, ResMed’s First Minimal-Contact Full Face CPAP Mask, Now Available in the U.S., Canada15.10.2018 16:05 | Tiedote
ResMed (NYSE: RMD, ASX: RMD) today announced the availability of its first minimal-contact full face CPAP mask, AirFit F30, the latest addition to its AirFit mask portfolio, which helps sleep apnea patients reduce facial marks, wear glasses in bed and curl up closer to their bed partner. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005185/en/ AirFit F30 full face CPAP mask: Side View (Photo: Business Wire) Availability AirFit F30 is available for sale now in the United States and Canada, and will be on display at the Medtrade Fall conference this week in Atlanta; visit ResMed’s Booth #2116. AirFit F30 fits 93 percent of patients,1 and features a minimal-contact cushion that sits just below the nose, preventing top-of-the-nose red marks and irritation, plus reducing feelings of claustrophobia for some full face wearers. It also has ResMed’s QuietAir vent, making the mask quieter than ambient noise in the bedroom. New
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme