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
Om 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.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Workiva Named Best-In-Class Cloud Service Provider at UK Cloud Awards17.5.2019 12:00:00 CEST | Pressemelding
Workiva (NYSE:WK), the leading cloud provider of connected data, reporting and compliance solutions, was named the Best-In-Class Cloud Service Provider by the UK Cloud Awards 2019 at a ceremony here last night. Now in its sixth year, the UK Cloud Awards recognise innovation and excellence in the cloud industry by showcasing leading companies, customers and individuals in the United Kingdom. Workiva was recognised for its Wdesk platform that helps organisations consolidate, connect and tag their data in a single, cloud environment so they are able to reduce risk and save time when filing reports with various regulators and other stakeholders. Workiva, the global leader in XBRL and Inline XBRL, is also streamlining how customers comply with the European Securities and Markets Authority's mandate for Inline XBRL for European Single Electronic Format (ESEF) reporting. More than 5,000 EU issuers will be required to use ESEF taxonomy for their annual financial reports, ending on or after Jan
Novaremed Presents Top-Line Results from Phase 2a Diabetic Neuropathic Pain Study of NRD.E1 at NeuPSIG 201917.5.2019 10:13:00 CEST | Pressemelding
Novaremed AG, a clinical-stage Swiss biopharmaceutical company, today announced a poster presentation highlighting the top-line results from a Phase 2a (Proof of Concept) study of NRD.E1 for the treatment of diabetic neuropathic pain (DNP). The poster presentation took place at the 7th International Congress on Neuropathic Pain Meeting (NeuPSIG) in London, UK on May 9-11, 2019. “This was our first communication at a leading neuropathic pain-focused event. Novaremed’s lead drug, NRD.E1 is a non-opioid small molecule for the treatment of neuropathic pain. The results of our Phase 2a in patients with DNP showed clinically relevant treatment benefit from NRD.E1 across multiple primary and secondary endpoints, providing a strong scientific foundation for advancing the development of NRD.E1 into the upcoming global Phase 2b study in DNP,” said Sara Mangialaio, Head of R&D and Chief Medical Officer of Novaremed AG. “NRD.E1 has the potential to address a major unmet medical need in DNP.” Poste
WIN 2019 Symposium: WINnovation and Global Deployment of Precision Oncology17.5.2019 09:38:00 CEST | Pressemelding
The 11th WIN Symposium in Precision Oncology will be held in Paris, France on June 23-24, 2019. ASCO® endorsed for the past 11 years, the WIN symposium will deliver an exciting line-up of speakers in Paris (France) on June 23-24, 2019 to discuss Innovation and Global Deployment of Precision Oncology. The current status of Precision Oncology across the globe will be examined with the exceptional participation of the chairmen of the event, Richard L. Schilsky, Chairman WIN Consortium(*), Senior Vice-President and Chief Medical Officer of ASCO, and Josep Tabernero, Vice Chairman WIN Consortium, President of ESMO and Director of Vall d’Hebron Institute of Oncology, Spain. Global experience will be shared: Optimizing Patient Enrollment and Efficacy of Precision Oncology Clinical Trials at UT MD Anderson Cancer Center, USA Decision Support for Precision Oncology: Evolving from Monotherapy to Genomically Informed Combinations, UT MD Anderson Cancer Center, USA The Value of Personalized Medici
Corsearch Acquires Principium Trademark Watch and Domain Services Businesses17.5.2019 08:00:00 CEST | Pressemelding
Corsearch, the global brand creation, clearance, and protection leader, is pleased to announce the acquisition of the Principium Strategies trademark watch and domain services businesses, the brand protection subsidiary of Ladas and Parry LLP, a leader in global intellectual property law. The acquisition is effective immediately, solidifying and expanding Corsearch’s full-service trademark solutions offering for clients and brands globally. Principium is Corsearch’s third acquisition since becoming a standalone company in January 2018. The acquisition brings Corsearch’s employee count to more than 350 operating in 28 locations worldwide and adds valuable industry expertise and additional capabilities to Corsearch. “This is another really exciting acquisition for our business and a step forward in the evolution of Corsearch,” said Stephen Stolfi, Chief Commercial Officer of Corsearch. “Principium has provided clients with industry-leading trademark watching services for over 80 years an
CNT Among SAP’s "Best of the Best"17.5.2019 08:00:00 CEST | Pressemelding
Since 2005, SAP is honoring the best of the best SAP projects yearly in Europe, Middle East and Africa. In 2018, 280 customers from 15 markets submitted their regional Gold Award-winning projects. CNT Management Consulting from Vienna won Bronze twice – together with its customers HOERBIGER and TANNPAPIER – a happy day for CNT’s CEO Andreas Doerner. "We are now on the podium for the second time with two projects – thanks to the trust of our customers." The SAP Quality Awards EMEA were presented at an exceptionally festive ceremony in Heidelberg Castle (Baden-Wuerttemberg), and only twelve SAP customers were able to take home the most wanted trophies that were presented by SAP Presidents Brian Duffy (EMEA North) and Hartmut Thomsen (Middle and Eastern Europe). The jury evaluated the projects according to the ten SAP quality principles and the question of whether the respective project could fulfill the expectations of its clients. HOERBIGER - Category Business Transformation Headquarter
EVER Pharma acquires Amneal Deutschland GmbH and extends its commercial presence in Europe17.5.2019 07:25:00 CEST | Pressemelding
EVER Pharma Holding Ges.m.b.H (Austria) announced today that it has completed the acquisition of Amneal Deutschland GmbH, a subsidiary of Amneal Pharmaceuticals that operates the company's commercial operations in Germany. Amneal Deutschland already distributes several EVER Pharma products in Germany and is a strongly established player in the German hospital market. The acquired entity will be rebranded to EVER Pharma GmbH. “This acquisition represents another milestone in the expansion of EVER Pharma’s commercial footprint in Europe. With this new operation, EVER Pharma extends its portfolio in Germany and establishes a solid platform for the growth of its portfolio and pipeline” commented Georges Kahwati, General Manager of EVER Pharma. “We are pleased to establish another EVER affiliate in one of the key European markets in line with our strategy of establishing our own business presence in core markets.” added Julia Hillebrand, Managing Director and Owner. About EVER Pharma: EVER