CelltrionHealthcare

Celltrion Healthcare receives positive CHMP opinion for an additional five indications for Remsima® SC including for use in inflammatory bowel disease and ankylosing spondylitis

· 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 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

FRIDAY 26 JUNE- INCHEON, SOUTH KOREA - 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 ofpeoplewith 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 resultsshowed 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 bytheEMA, 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 -

Notesto Editors:

About CT-P13 intravenous (IV) formulation[4]

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

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