Celltrion Healthcare Receives CHMP Positive Opinion for Novel Subcutaneous Formulation of CT-P13 (biosimilar infliximab) for the Treatment of People With Rheumatoid Arthritis

Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for CT-P13 SC for marketing authorisation in the European Union (EU) in people with rheumatoid arthritis (RA). CT-P13 SC is the subcutaneous version of Remsima^® (biosimilar infliximab, CT-P13). This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines in the EU.

A subcutaneous formulation has the potential to enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration.^1,2

“Today’s positive CHMP opinion brings us one step closer to providing a personalised treatment approach for people living with rheumatoid arthritis. This marks an important milestone for our business providing people with a new route of administration, and a novel formulation of infliximab,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “If approved, we will begin a new era in the biotherapeutic class, as CT-P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients.”

This positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version in people with active RA.

Part one of the study demonstrated that CT-P13 SC showed comparable efficacy to CT-P13 IV up to week 54 with comparable DAS28 (CRP) / DAS28 (ESR) and ACR20 scores (measures of disease activity) demonstrated for both routes of administration. The safety profile of CT-P13 SC was also comparable to CT-P13 IV.¹ The study was followed up by a phase I/III randomised controlled trial (part two) which demonstrated non-inferiority in efficacy of CT-P13 SC to CT-P13 IV in people with RA over 30 weeks with similar DAS28 and ACR20, ACR50, ACR70 scores and EULAR-CRP response. The safety profile of CT-13 SC was comparable to CT-13 IV up to week 30.²

Global Principal Investigator Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium said, “This announcement is very encouraging as CT-P13 SC has demonstrated a comparable safety and efficacy profile to the well-established intravenous version of infliximab. This new SC formulation of infliximab could give patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment. Having two formulations of CT-P13 could also benefit patients by offering a more personalised treatment option whilst also reducing the time spent in hospital having intravenous treatment alone.”

A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hope to seek expanded indications following the results of this trial.

Celltrion Healthcare will adopt a different business strategy for CT-P13 SC, compared to strategies for previous products in the portfolio and is considering both direct and indirect sales based on the optimal model in each local country.

Celltrion has applied for a patent for CT-P13 SC in approximately 130 countries throughout the US, Europe and Asia.

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Notes to Editors:

About CT-P13 intravenous (IV) formulation³

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.

About CT-P13 subcutaneous (SC) formulation^1,2

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 89 countries (as of September 2019) 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: http://www.celltrionhealthcare.com/

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 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.

² 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.

³ 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 September 2019].

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