• The positive Committee for Medicinal Products for Human Use (CHMP) opinion recommends expanding the marketing authorisation for the subcutaneous (SC) formulation of Remsima^® for use in an additional five indications, including for the treatment of inflammatory bowel disease (IBD) and ankylosing spondylitis (AS); the CHMP’s positive opinion for the SC formulation applies to all previously approved indications for the intravenous (IV) formulation in adult patients
• The CHMP opinion is based on pivotal study data evaluating the pharmacokinetics, efficacy and safety between the IV and SC formulations of Remsima^® in people with active Crohn’s disease and ulcerative colitis
• The availability of the novel SC formulation of Remsima^® could provide patients with an alternative, more personalised and convenient treatment option

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima^® (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. This follows the EU marketing authorisation for Remsima^® SC for the treatment of people with rheumatoid arthritis issued in November 2019.¹

“Today’s positive CHMP opinion marks an important step forward in furthering our ability as clinicians to meet the needs of people with autoimmune diseases. Remsima^® SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,” said Professor Walter Reinisch, Director of the Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medizinische Universität Wien. “Given the current COVID-19 pandemic, this is timely and welcome news, particularly for immunocompromised patients who must take extra precaution and only visit hospitals when absolutely necessary.”

The subcutaneous formulation can be administered by patients themselves, thereby providing alternative treatment options giving them greater flexibility and control.

The positive CHMP opinion was supported by data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the subcutaneous and intravenous (IV) formulations of Remsima^® in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.^2,3

Part one of the study showed a comparable overall clinical response of CT-P13 SC to CT-P13 IV as indicated by the Crohn’s Disease Activity Index (CDAI-70) with similar scores, whereas clinical remission was numerically higher in the SC cohorts at week 54. The safety profiles of CT-P13 in the SC cohorts was comparable to CT-P13 IV up to week 54.²

In part two of the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of which 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 5 mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (<80 kg) 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.³

The results showed that both the mean CDAI and partial Mayo scores for ulcerative colitis disease activity 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 from week 30 of the trial. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in Crohn’s disease and ulcerative colitis combined was further improved at week 54. After switching, the mean pre-dose serum concentrations in the IV arm increased to a level comparable to the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, was comparable between both the SC and IV arms.³

Based on the above results, a 120 mg fixed dose of Remsima^® SC has been recommended for use by the CHMP, in adults regardless of the body weight, in both existing and newly added indications.

“Since its first launch, Remsima^® has been used for more than 5 years in over 90 countries. This positive CHMP opinion is very encouraging and brings us closer to improving outcomes for more patients who are eligible to receive the subcutaneous formulation,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “If approved by the EMA, Remsima^® will be the first infliximab to have both intravenous and subcutaneous formulations to treat patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.”

Celltrion has completed its application process for patent protection for the Remsima^® SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia.

- ENDS -

Notes to Editors:

About CT-P13 intravenous (IV) formulation⁴

CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg 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.

About CT-P13 subcutaneous (SC) formulation^5,6

A 120 mg fixed dose of CT-P13 SC has been recommended for use by the CHMP, in adults regardless of the body weight, in both existing and newly added indications. CT-P13 SC 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.

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 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 US FDA approved CT-P13 in April 2016 under the trade name Inflectra^®. CT-P13 is approved in more than 94 countries (as of June 2020) 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 endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

Forward-looking statement disclaimer

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 Healthcare, that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” 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 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 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 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 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2020 Last accessed June 2020.

² 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-1103.22.

³ 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.

⁴ 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 June 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.

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