Business Wire

Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis presented at The European Crohn's and Colitis Organisation (ECCO) annual congress

Share

Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC). Results presented at The European Crohn's and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.1

In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (<80kg) or 240 mg (≥80 kg) every 2 weeks in the SC arm, or continued on IV 5 mg/kg every 8 weeks in the IV arm. From week 30 onwards, the IV 5 mg/kg group were switched to either SC 120 or 240 mg based on the patients’ body weight.1

Professor Shomron Ben-Horin, MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, and one of the lead investigators of the trial said, “the 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV. These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.” Professor Ben-Horin added, “It is exciting to hear that the abstract has been selected as one of the Highlights of ECCO and I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months.”

The study showed that the mean CDAI and partial Mayo scores decreased over time in both arms until week 30, while comparable improvement in clinical activity was observed at week 54 - after switching the remaining IV patients to SC. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in CD and UC combined was further improved at week 54. Furthermore, after switching the mean pre-dose serum concentrations in the IV arm increased to a comparable level as the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, were comparable between both the SC and IV arms.1

The results were presented as part of oral presentation ‘OP24: A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s Disease and Ulcerative Colitis’, which was selected for inclusion in the Highlights of ECCO by organisers.

“CT-P13 SC (Remsima® SC) is the first and only subcutaneous infliximab to be available in Europe offering patients who are starting or switching anti-TNF-α therapy with the proven benefits of infliximab in a more convenient form. Starting with Germany, we have started launching the new subcutaneous infliximab country by country by establishing local operations across major European countries, building our commercial capabilities and strengthening our relationships with stakeholders across these markets” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare.

Celltrion is seeking approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC (Remsima® SC) in mid-2020, following EU marketing authorisation for the treatment of people with rheumatoid arthritis in late 2019.

--- ENDS ---

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.2 They affect an estimated 5 million people globally;3 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.4

About CT-P13 (biosimilar infliximab)5 ,6,7
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 RA 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 U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of February 2020) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. Celltrion has submitted a further variation to the marketing authorisation of CT-P13 SC to extend the indication to other disease areas including inflammatory bowel disease. In the United States, Remsima® SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval by 2022.

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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

References


1 Ben-Horin, S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s Disease and Ulcerative Colitis. Oral presentation (OP24) Presented at ECCO 2020.
2 Molodecky, N. A, et al. (2012). Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed February 2020].
3 The European Federation of Crohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science
Retrieved from www.efcca.org/en/science [Last accessed February 2020].
4 Burisch, J, et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrieved from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed February 2020].
5 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019.
6 Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019.
7 European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed February 2020].

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0)20 3817 6597

Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 (0)20 3817 6718

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 23:14:00 EET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/ Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management28.3.2024 19:02:00 EET | Press release

HTEC, a global digital consulting, software engineering, and product development company, is announcing a strategic collaboration with G2 Risk Solutions (G2RS), the preeminent provider of end-to-end bankruptcy technology solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328622816/en/ HTEC & G2 Risk Solutions Partnership (Photo: Business Wire) Under the agreement, G2RS will engage HTEC to incorporate its leading-edge technology into G2RS’ premier bankruptcy management platform. As the creators of the most comprehensive national bankruptcy database and the first bankruptcy management portal, G2RS is an industry pioneer. By adding HTEC’s premium engineering to the G2RS technology stack, G2RS will offer new and innovative functionalities to help clients expedite financial recoveries, increase data protection, and reduce operational inefficiencies in the bankruptcy management life cycle. “We are thrilled to be a part o

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 18:00:00 EET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 18:00:00 EET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 18:00:00 EET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye