Celltrion Healthcare showcases initial data from year-long study for subcutaneous formulation of CT-P13 (biosimilar infliximab) in patients with Crohn’s disease
New data presented at the 14th congress of European Crohn’s and Colitis Organisation (ECCO) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with Crohn’s Disease (CD) up to week 54.1
The randomised, controlled phase I study evaluated efficacy, pharmacokinetic (PK) parameters and the overall safety profile of CT-P13 SC throughout the 1-year treatment period.
In the study, 44 patients with moderate to severe CD were randomly assigned into four cohorts; one group receiving CT-P13 IV 5mg/kg every 8weeks and the other three receiving different doses of CT-P13 SC (120mg/180mg/240mg) bi-weekly up to week 54. From week 6 to week 30, the results showed comparable overall clinical response of CT-P13 SC to CT-P13 IV with similar CDAI-70 scores, whereas clinical remission appears to be numerically higher in the SC cohorts at week 54. The safety profiles of CT-P13 in the SC cohorts were comparable to CT-P13 IV up to week 54.1
Celltrion also presented PK and overall safety profile data for two administration methods for CT-P13 SC - auto-injection (AI) and pre-filled syringe (PFS). As part of the study, 218 healthy subjects were randomly split into two groups to receive 120mg of CT-P13 SC via AI or PFS for 12 weeks. The results showed a similar PK and safety profile between CT-P13 SC being administered via AI and PFS, however the study showed administration via AI led to fewer injection site reactions and reduced pain.2 AI also has the potential benefit of being simpler to self-administer and reducing patient distress compared to administration via PFS, meaning that this could be a preferable administration option for CT-P13 SC.
Professor Walter Reinisch, Director of clinical IBD study group, Department of Gastroenterology and Hepatology, Medizinische Universität Wien said, “The year-long results show a comparable PK, efficacy and safety profile between CT-P13 SC and IV. This data is encouraging in showing that CT-P13 SC is safe and efficacious as a treatment for Crohn’s disease and the SC formulation has the potential to be used as an alternative infliximab treatment in the future. CT-P13 SC could become a game-changer in biosimilar treatment by improving convenience and allowing patients to be more in control of their treatment.”
Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “The availability of a subcutaneous version of CT-P13 will be an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases such as Crohn’s disease. We are committed to providing physicians with treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous. If CT-P13 SC is approved in Europe, the dual formulation of infliximab could offer patients a more convenient treatment option.”
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.3 They affect an estimated 5 million people globally.4 IBD accounts for substantial costs to the healthcare system and society; the direct healthcare costs of IBD is estimated to be €4.6-5.6 billion per year.5
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 Commission (EC). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 89 countries (as of Nov 2018) including the US, Canada, Japan and throughout Europe.
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/
1 Reinisch W, et al. A novel formulation of CT-P13
(infliximab biosimilar) for subcutaneous administration: 1-year result
from a phase 1 open-label randomised controlled trial in patients with
active Crohn’s disease. European Crohn’s and Colitis Organisation 2019.
Abstract no: A-1103.
2 Schreiber S, et al. Development of a novel auto-injector of subcutaneous CT-P13 infliximab: Phase 1 randomised, open-label, single-dose trial to compare the pharmacokinetics and safety to pre-filled syringe in healthy subjects. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1165.
3 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.
4 The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Available at: http://www.efcca.org/en/science.
5 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
ABSTRACT NUMBER: A-1103
DATE AND TIME OF PRESENTATION:
March 8th, 17:47 – 17:53 CET
ABSTRACT NUMBER: A-1165
DATE AND TIME OF PRESENTATION:
March 8th, 12:30 CET
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
PayPal Expands its International Money Transfer Service Xoom to 32 Markets across Europe15.7.2019 23:01:00 CEST | Press release
Today, PayPal launched Xoom—its international money transfer service—in 32 markets1 across Europe. People in these markets can now use Xoom to quickly send money, pay bills or top up phones to more than 130 markets internationally. Xoom’s expansion to Europe is a significant milestone and another example of PayPal fulfilling its mission to make the movement and management of money more convenient, accessible, secure and affordable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190715005823/en/ Xoom Launches in 32 Markets Across Europe (Photo: Business Wire) The global remittance market reached $689 billion in 2018, up from $633 billion in 2017 according to World Bank data2. In 2019, remittance flows to low- and middle-income countries are expected to reach $550 billion, to become their largest source of external financing. The global average cost of sending $200 remained high, at around 7 percent in the first quarter of 201
ResMed Inc. Completes $500M Private Placement Debt Offering15.7.2019 20:05:00 CEST | Press release
ResMed Inc. (NYSE: RMD, ASX: RMD) announced today the successful pricing and closing of a private placement offering of $250,000,000 principal amount 3.24% senior notes due July 10, 2026, and $250,000,000 principal amount 3.45% senior notes due July 10, 2029. Net proceeds from the offering will be approximately $498 million, after deducting estimated fees and expenses related to the offering. The net proceeds will be used to pay down current borrowings on ResMed’s senior unsecured revolving credit facility. The notes are senior unsecured obligations of ResMed, and jointly and severally guaranteed by each Subsidiary Guarantor. “We are pleased to complete this U.S. private placement offering on attractive terms,” said Brett Sandercock, ResMed’s chief financial officer. “The transaction significantly lengthens our average debt maturity profile and provides improved visibility on our long-term funding costs.” This private placement offering is exempt from the registration requirements of t
SpeeDx Receives Clearance from Health Canada for ResistancePlus® MG Test15.7.2019 15:00:00 CEST | Press release
SpeeDx Pty. Ltd. today announced Resistance Plus® MG has been cleared by Health Canada and is now available for sale across all Canadian provinces (not currently available in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen, along with genetic markers linked to antibiotic resistance. This is the first commercially available test in Canada combining identification and therapeutic guidance information to support Resistance Guided Therapy for management of Mgen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190715005544/en/ (Photo: Business Wire) Current Canadian management guidelines for Mgen direct laboratories to forward positive samples to the National Microbiology Laboratory for resistance testing.1 Now Canadian laboratories can utilize Resistance Plus MG and bring this service inhouse to generate more timely results for doctors and their p
Mouser Electronics Now Stocking Broad Portfolio of Xilinx Products15.7.2019 14:55:00 CEST | Press release
Mouser Electronics, Inc. today announces a new global distribution agreement with Xilinx, Inc., the leader in adaptive and intelligent computing, to stock one of the industry’s broadest portfolios of Xilinx products, including digital downloads of development software and IP. Xilinx is the inventor of the FPGA, hardware programmable system-on-chips (SoCs) and the adaptive compute acceleration platform (ACAP), designed to deliver the most dynamic processor technology in the industry and enable the adaptable, intelligent and connected world of the future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190715005546/en/ Mouser Electronics proudly announces a new global distribution agreement with Xilinx, Inc., the leader in adaptive and intelligent computing. Mouser will stock one of the industry’s broadest portfolios of Xilinx products. (Graphic: Business Wire) To learn more, visit www.mouser.com/xilinx. “Xilinx is an industry
Rimini Street Becomes Support Service Provider for Hyundai-Kia Motors’ Global Database Portfolio15.7.2019 13:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that it has been selected as the software support services provider to global auto manufacturer Hyundai-Kia Motors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190715005161/en/ Rimini Street announced that it has been selected as the software support services provider to global auto manufacturer Hyundai-Kia Motors. (Photo: Business Wire) By providing efficient, timely, and cost-effective database maintenance and support, Rimini Street plans to actively support Hyundai-Kia Motors in their endeavor to implement a business-driven IT roadmap. Cost Optimization and Desire for Quality Support To support response to paradigm shifts in the automobile industry and active technology innovation, Hyundai-Kia Motors se
Värde Partners Appoints Co-CEO15.7.2019 12:12:00 CEST | Press release
Värde Partners, a leading global alternative investment firm, today announced that Ilfryn Carstairs will join George Hicks, Co-Founder and Chief Executive Officer, as Co-CEO, effective January 1, 2020. George co-founded Värde Partners 25 years ago and intends to transition to an Executive Chair role in 2022. Ilfryn will retain his role as Global CIO. “Transition is a process and involves the entirety of the firm. The roles Ilfryn and I play are just part of that process whereby a new generation of leaders succeed the founders,” said George. “Ilfryn joined us 12 years into this journey and has grown as both an investor and a leader. His skills in both pursuits will enable Värde to continue delivering for our investors and will help to ensure that we maintain our strong culture long into the future.” Ilfryn is a Partner and Co-Chief Investment Officer overseeing the global investment strategy for Värde. He co-chairs the firm’s Investment Committee. Based in Singapore since 2017, he joine