CelltrionHealthcare

Celltrion Healthcare Presents Efficacy and Safety Data From Global Phase III LIBERTY Trial, at the 18th ECCO Congress

March 3, 2023, CHICAGO, IL –

Today, Celltrion Healthcare presented new data demonstrating the efficacy and safety of subcutaneous (SC) infliximab (CT-P13 SC) in patients with inflammatory bowel disease (IBD). The data were presented in a digital oral presentation and poster presentations at the 18th European Crohn’s and Colitis Organisation (ECCO) annual congress, in Copenhagen, Denmark.

CT-P13 SC LIBERTY Studies

LIBERTY-CD and LIBERTY-UC were randomized, placebo-controlled, double-blind, Phase III studies designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC), respectively. [1][2]

In the CT-P13 SC LIBERTY-CD study, a total of 343 patients were randomized in a 2:1 ratio at Week 10. At Week 54, the clinical remission rate was greater in the CT-P13 SC arm than the placebo arm (62.3% and 32.1% respectively, P<0.0001). In the CT-P13 SC LIBERTY-UC study, a total of 438 patients were randomized at Week 10. The rate of clinical remission at Week 54 was significantly greater in CT- P13 SC (43.2%) compared to the placebo (20.8%) (P<0.0001). The safety profile during the maintenance phase was comparable between CT-P13 SC and the placebo arms for both studies.

"These latest findings add to the growing body of evidence that supports the SC formulation of infliximab as a convenient and effective solution for treating IBD,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the digital oral presentation. “These results demonstrate that maintenance therapy with CT-P13 SC provides a robust clinical benefit, with the convenience of SC administration, for patients with moderately to severely active CD and UC.”

“The positive global Phase III LIBERTY studies have allowed us submit CT-P13 SC to the FDA as a stand-alone Biologics License Application under the 351 (a) pathway and the results have also reinforced our conviction in the value of CT-P13 SC,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. “We believe that CT-P13 SC, if approved in the U.S., has the potential to become the next-generation innovative therapeutic for IBD given its favorable clinical results and convenient subcutaneous route of administration.”

CT-P13 SC PHASE I POST-HOC ANALYSIS AND REAL-WORLD CASE STUDIES

A separate post-hoc analysis of the randomised Phase I CT-P13 SC study data showed C_trough level predicted anti-drug antibody (ADA) and neutralizing antibody (NAb) positivity in CD and UC patients, with a C_trough threshold of 4.695 μg/mL significantly associated with lower rates of ADA and NAb positivity.[3]

In addition, real-world case studies presented during a satellite symposium at the ECCO congress indicate that reintroduction of infliximab may be a viable treatment option for CD patients with previous anti-TNF treatment failure, by aiming to reach a higher pharmacokinetics level and lower anti-drug antibody levels. Interim results of a pilot study suggest that SC infliximab may be a viable treatment option for patients with refractory CD.[4]

"Whilst there have been numerous recent advancements in IBD treatment options, there remains a pressing demand to address unmet medical need, especially for refractory IBD patients,” said Professor Milan Lukas, ISCARE and Charles University, Czech Republic, and one of the leading presenters for the satellite symposium. “These exploratory results suggest that SC infliximab could provide healthcare providers with a powerful treatment tool for CD patients who have previously been considered difficult to treat.”

- ENDS -

Notes to Editors:

About subcutaneous (SC) formulation of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. The SC formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration. [5][6]

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 Current Good Manufacturing Practice (cGMP) and EU GMP guidelines. Celltrion Healthcare endeavours 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/

About inflammatory bowel disease

Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, disabling gastrointestinal disorders that can significantly impact patients’ lives.[7] They affect an estimated 10 million people globally.[8] 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. [9]

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

REFERENCES

[1]Jean F. Colombel et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: A Phase 3, randomised, placebo-controlled study (LIBERTY-CD). Digital Oral Presentation (DOP86). Presented at ECCO 2023.

[2]Bruce E. Sands et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A Phase 3, randomized, placebo-controlled study: Results of the LIBERTY-UC study. Poster (P492). Presented at ECCO 2023.

[3]Stefan Schreiber et al., Predictors of immunogenicity in patients with inflammatory bowel disease treated with infliximab: A post hoc analysis of the randomised Phase I CT-P13 SC study. Poster (P524). Presented at ECCO 2023.

[4]Lukas M et al. Infliximab CT P13 SC in refractory Crohn's disease patients preliminary results of a pilot project Poster (P030). Presented at Crohn’s and Colitis Congress 2023.

[5]A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease, Journal of Crohn's and Colitis, Volume 13, Issue Supplement_1, March 2019, Pages S066–S067, https://doi.org/10.1093/ecco-jcc/jjy222.096 [Last accessed February 2023].

[6]R.Westhovens 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]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 2023].

[8]The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Retrieved from www.efcca.org/content/what-ibd [Last accessed February 2023].