Celltrion USA Announces Biologics License Application (BLA) Submission of New CT-P13 Subcutaneous Formulation to US Food and Drug Administration

CHICAGO–(COMMERCIAL THREAD)–Celltrion USA today announced it has filed a Public Health Service Act Route 351(a) Biologics License Application (BLA) (a “stand-alone” BLA) for its lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab for the US Food and Drug Administration (FDA). The planned initial submission package will seek approval of CT-P13 SC for the treatment of inflammatory bowel disease (IBD).

This BLA filing marks a significant milestone for Celltrion, and we are working with the FDA to bring this innovative treatment to the U.S. market,” said Hyoung Ki Kim, Vice President and CEO of Celltrion Healthcare. “We are committed to advancing innovative treatments that provide improvements in clinical outcomes and pharmacological pharmacology and reduce the burden on patients on their daily lives.”

The presentation is based on results from the pivotal Phase III data evaluating the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderately to severely active ulcerative colitis (UC) (LIBERTY-UC) and Crohn’s (CD) ( LIBERTY-CD). Based on the results of the LIBERTY-UC and LIBERTY-CD studies, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy of the intravenous formulation of infliximab in patients with UC and CD, respectively, for a period of treatment for one year.1.2

A subcutaneous formulation has the potential to improve therapeutic options for the use of the drug infliximab by providing high uniformity in drug exposure and a convenient method of administration.3.4

We are excited about the potential of CT-P13 SC as it allows patients to be in greater control of their treatment, providing greater independence and convenience,” said Jaeik Shim, Chief Operating Officer, Celltrion USA. “In addition, CT-P13 SC frees the burden of traveling to treatment for intravenous infusions, reducing treatment-related travel costs for patients and healthcare professionals.”

Notes to editors:

Learn about the LIBERTY-UC pivotal study

LIBERTY-UC is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of CT-P13 subcutaneous (CT-P13 SC) in terms of efficacy and safety during maintenance therapy in patients with active moderate to severe UC. A total of 438 patients were randomized at week 10. The clinical remission rate at week 54 was significantly greater in CT-P13 SC (43.2%) than in placebo (20.8%) (P<0.0001 ). The safety profile during the maintenance phase was generally comparable between the CT-P13 SC and placebo arms.

Learn about the LIBERTY-CD pivotal study

The LIBERTY-CD is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of CT-P13 subcutaneous (CT-P13 SC) in efficacy and safety during maintenance therapy in patients with active disease moderate to severe CD. A total of 343 patients were randomized at week 10. At week 54, the clinical remission rate was higher in the CT-P13 SC arm than in the placebo arm (62.3% and 32.1%, respectively, with P<0. 0001). The safety profile during the maintenance phase was generally comparable between the CT-P13 SC and placebo arms.

Information on subcutaneous (SC) injection of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A fixed dose of 120 mg CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and recently added indications. The SC formulation has the potential to improve therapeutic options for the use of the drug infliximab by providing high uniformity in drug exposure and a convenient method of administration.3.4

About Celltrion Healthcare

Celltrion Healthcare is committed to providing innovative and affordable medicines to promote patient access to advanced therapies. Its products are manufactured in state-of-the-art mammalian cell culture facilities, designed and built to comply with US FDA Current Good Manufacturing Practice (GMP) guidelines and EU GMP guidelines. Celltrion Healthcare is committed to offering cost-effective, high-quality solutions through an extensive global network spanning more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA

Celltrion USA is the US subsidiary of Celltrion Healthcare founded in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to next-generation biopharmaceuticals to improve care for US patients. Celltrion currently has four biosimilars approved by the US FDA: Remsima® (infliximab), truxima® (rituximab), Herzuma® (trastuzumab) and Vegzelma® (bevacizumab). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for US patients.

FORWARD STATEMENT

Certain information contained in this press release contains statements regarding our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, pursuant to applicable securities laws.

These statements can be identified by words such as ‘prepares’, ‘hopes to’, ‘coming soon’, ‘plans to’, ‘aims for’, ‘to be launched’, ‘is preparing, ‘when achieved’, ‘ could”, “for the purpose of”, “may”, “once identified”, “will”, “work towards”, “is due”, “become available”, “has the potential to”, the negative of these words or any such other variations thereof or comparable terminology.

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Forward-looking statements are provided to provide prospective investors the opportunity to understand management’s beliefs and opinions regarding the future so that they can use those beliefs and opinions as a factor in evaluating an investment. These statements are not guarantees of future performance and you should not place undue reliance on them.

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

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

References

1 CT-P13 (Infliximab) Subcutaneous administration in patients with moderately to severely active ulcerative colitis (LIBERTY-UC). ClinicalTrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT04205643#wrapper [Last Accessed December 2022]

2 CT-P13 (Infliximab) Subcutaneous administration in patients with moderately to severely active Crohn’s disease (LIBERTY-CD). ClinicalTrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT03945019 [Last Accessed December 2022]

3 Reinisch W et al. DOP62 A novel formulation of CT-P13 (biosimilar infliximab) for subcutaneous administration: 1-year outcome of an open-label phase I randomized 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

4 Westhovens R, Wiland P, Zawadzki M et al. A new formulation of CT-P13 (biosimilar infliximab) for subcutaneous administration: 30-week results from the second part of a phase I/III randomized controlled trial in patients with rheumatoid arthritis. Poster (SAT0170) Presented at EULAR 2019.

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