Celltrion Healthcare receives positive CHMP opinion for Remsima® SC for direct use of subcutaneous therapy without IV loading
2021-03-31
Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis The Committee for Medicinal Products for Human Use (CHMP) recommends that Remsima® SC can be initiated without IV loading in patients with rheumatoid arthritis (RA) The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading The availability of the subcutaneous induction therapy could potentially shorten drug administration time, reduce healthcare practitioner time, and offer additional flexibility for patients March 31, 2021 05:04 AM Eastern Daylight Time 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 Remsima® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).1 As a result of the CHMP opinion, if agreed by European Commission (EC), Remsima® SC 120 mg can be used without IV infusion both for new and existing RA patients. The recommended posology for newly diagnosed or newly infliximab-initiated patients, suggests that Remsima® SC should be initiated as a subcutaneous injection at week 0 and additional injections will be given at week 1, 2, 3 and 4 after the first injection. Then, maintenance therapy will be followed every 2 weeks thereafter. For existing patients, Remsima® SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV. “IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients especially given the current COVID-19 pandemic,” said Professor Roberto Caporali, Professor of Rheumatology at the University of Milan and Head of Rheumatology Unit of Gaetano Pini Hospital, Milan Italy. “The direct subcutaneous induction of the SC formulation of infliximab could potentially shorten drug administration time via self-administration at home, reduce healthcare practitioner time and burden on healthcare system, as well as offering additional flexibility and convenience for patients.” Previous pharmacoeconomic model which estimates delivering subcutaneous infliximab with IV induction regimen yields savings of 21 million GBP compared to IV infliximab when treating British RA patients in one-year time frame. Remsima® SC without IV induction can generate additional saving of 14 million GBP. All models project potential savings from IV administration costs thus societal gain may be greater than the estimates.2 “Today’s positive CHMP opinion marks a step forward in our goal to provide flexible treatment schedules to patients with rheumatoid arthritis especially under COVID-19 situation,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. "If the recommendation of EMA is agreed by EC, Remsima® SC could be used without IV infusion for newly initiated patients as well as patients currently on infliximab treatment.” - ENDS - Notes to Editors: About Remsima® (CT-P13) intravenous (IV) formulation1Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (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 Remsima® CT-P13 subcutaneous (SC) formulation3,4A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® 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 96 countries (as of March 2021) including the US, Canada, Japan and throughout Europe. About Celltrion HealthcareCelltrion 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us References 1 Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation | European Medicines Agency (europa.eu). [Last accessed 29 March 2021] 2 M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020 3 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. 4 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.
EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Uni
2021-03-26
EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union Positive scientific opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) supports national authorities within European (EU) member states on the use of regdanvimab (CT-P59) for the treatment of COVID-19, prior to formal marketing authorisation being granted Rolling review of regdanvimab (CT-P59) has been initiated by the EMA in parallel, to accelerate time to potential marketing authorisation Regdanvimab (CT-P59) demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2 Initial sales agreements for regdanvimab (CT-P59) have been made for Nordic countries March 26, 2021 11:20 PM Greenwich Mean Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). The CHMP recommends that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.1 Under Article 5 (3) of Regulation 726/2004, the CHMP’s scientific opinion provides a harmonised EU- level opinion on the efficacy, quality and safety of antibodies. The scientific opinion can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorisation. The EMA has also initiated a rolling review of regdanvimab based on data from animal studies (non- clinical data) and clinical trials, in addition to data on the quality of the medicine. The EMA uses its rolling review process to accelerate the assessment of a promising medicine during a public health emergency and once finalised it will provide the basis of an EU marketing authorisation for the monoclonal antibody treatment. “Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 worldwide. Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We believe the CHMP’s positive opinion will accelerate reviews and authorisations by national authorities who may take evidence-based decisions on the use of our therapy. We will also continue to work in close collaboration with the EMA to complete the rolling review and marketing authorisation process.” Regarding mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants. Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, commented, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.” - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About CT-P59 (regdanvimab) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralize the wild type and mutant viruses of concern including the UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. 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 EMA issues advice on use of regdanvimab for treating COVID-19 | European Medicines Agency (europa.eu). Last accessed 26 March 2021. 2 Celltrion Data on file
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Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab
Yuflyma™ (CT-P17) is the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation; 60% of adalimumab market captured by high concentration formulation in Europe according to IQVIA Yuflyma™ is approved in all intended indications for the treatment of multiple chronic inflammatory diseases Yuflyma™ has 29G needle size, latex-free device, and a shelf-life up to 24 months (2-8℃); at room temperature Yuflyma™ is stable up to 30 days February 15, 2021 07:29 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma™ (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases. The EC approval of Yuflyma™ follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2020. The marketing authorisation is based on analytical, preclinical and clinical studies, demonstrating that Yuflyma™ is comparable to adalimumab, the reference product, in terms of safety, efficacy, PK/PD and immunogenicity up to 24 weeks1 and 1 year2 following treatment. Based on the results of the pivotal study, a high concentration formulation of Yuflyma™ has been approved for use in the European Union (EU), in patients with thirteen chronic inflammatory diseases; rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). “In Europe, according to IQVIA data, 60% of the whole adalimumab market has been taken by high concentration formulation and over 90% of the original adalimumab market has already been replaced with a high concentration version. With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we focused on development of a high concentration biosimilar to provide a significant alternative to the adalimumab treatment category,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “In terms of the administration device, we have looked to ensure improved convenience for patients as well as providers with the inclusion of needle size (29G), latex-free to reduce allergy risk, and a long storage period or shelf life at room temperature for 30 days.” Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany said, “Over the past two decades, anti-tumour necrosis factor (TNF) biologics have revolutionised the management of chronic immune-mediated inflammatory diseases, but some of the features needed improvement for patients to reach their therapeutic goals. As a physician, we welcome these value-added features such as high concentration and low-volume formulations to reduce injection discomfort.” The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway. This announcement will enable affordable access to a high concentration adalimumab biosimilar, broadening treatment alternatives for patients suffering with chronic inflammatory disease including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Celltrion will take the EC Decision Reliance Procedure (ECDRP) to minimise lead time to launch the product in the UK and remains committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. - ENDS - Notes to Editors: About CT-P17 (biosimilar adalimumab) CT-P17 is the first proposed high concentration, low- volume and citrate-free adalimumab biosimilar. CT-P17 is indicated for the treatment of patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. CT-P17 provides pain-reducing features as it comes with citrate-free formulation, meaning it causes less pain upon injection. 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us References 1 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020 2 Data on file
2021-02-15
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Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Plat
Celltrion is on track developing a neutralising antibody cocktail with Regdanvimab (CT-P59) tailored to fight against the emerging new variants CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2 Celltrion has constructed a COVID-19 antibody portfolio and clinical development platform to help combat the spread of the virus mutations February 11, 2021 12:18 AM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging virus mutations and that the company has initiated development of a neutralising antibody cocktail treatment with CT-P59. The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants. As of 19 January 2021, according to media and official sources, approximately 2,000 cases of the variant VOC 202012/01 (Variant of Concern, year 2020, month 12, variant 01, previously designated VUI, Variant under Investigation) had been identified in 60 countries. In the EU/EEA, about 1,300 cases have been identified in 23 countries. Outside the EU/EEA, approximately 700 cases have been identified in 37 countries.1 In order to elicit potent neutralising antibodies against the new emerging variants and to minimise lead time for introducing cocktail treatments with CT-P59, Celltrion previously captured a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 produced neutralising titres against new emerging strains in the UK and South Africa. Using an already constructed antibody portfolio and encouraged by confirmed potency on various mutants, Celltrion has commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. To date, CT-P59 has been shown to significantly reduce the risk of COVID-19 related hospitalisation and oxygenation up to Day 28, reduce rate of progression to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over, and significantly shorten the time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. A global Phase III clinical trial is currently recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of COVID-19 at more than 10 global sites to evaluate the efficacy and safety of CT-P59. Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, said, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.” Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About CT-P59 (Regdanvimab) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 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 Risk related to the spread of new SARS-CoV-2 variants of concern in the EU/EEA – first update 21 January 2021, European Center for Disease Prevention and Control. [Last accessed February 2021] 2 Celltrion Data on file
2021-02-11
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Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation
Celltrion’s COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVID-19 monoclonal antibody treatment to be approved in Korea CT-P59 is authorised for the treatment of adult patients aged 60 and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19 Celltrion is under discussion with the European Medicines Agency (EMA) for Conditional Marketing Authorisation (CMA) and with the U.S. FDA for Emergency Use Authorisation (EUA) The global Phase III clinical trial is on track and the trial is expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 February 05, 2021 08:26 AM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. The CMA allows for emergency use of CT-P59 in adult patients aged 60 years and over, or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. The CMA is based on Part 1 of the Phase II/III trial which showed; Patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalization and oxygenation up to Day 28 Progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over A significantly shortened time to clinical recovery in CT-P59 treated patients (40 mg/kg) ranging from 3.4 to 6.4 days quicker compared with placebo. “With the pandemic still raging in Korea, we believe today’s Conditional Marketing Authorisation of Regdanvimab marks an important milestone in the fight against COVID-19” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Patients with COVID-19 in Korea now have access to a therapy according to the authorised indications early in the course of their infection. We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as in the case of Korea.” A global Phase III clinical trial is currently recruiting and expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 in more than 10 global sites to evaluate efficacy and safety results of CT-P59. Celltrion is set to demonstrate clinical efficacy against COVID-19 in both UK and South African variants and the results to be expected in the coming days. - ENDS - Notes to Editors: About Celltrion HealthcareCelltrion 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About CT-P59 (Regdanvimab)CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.1 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 Celltrion Data on file
2021-02-05
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Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59
Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59 CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over CT-P59 (40mg/kg) treated patients reported a significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo A significant reduction of viral load compared to placebo was reported at Day 7 in patients treated with CT-P59; with CT-P59 receiving a positive safety profile and no drug-related serious adverse events reported The preclinical data of CT-P59 against SARS-CoV-2, demonstrating a 100-fold reduction in viral load of SARS-CoV-2 and improved recovery time in animal models has been published in Nature Communications journal JANUARY 13 2021, INCHEON, KOREA – Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia. This data analysis has demonstrated that at Day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality. When compared to placebo, CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over. CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. Patients treated with CT-P59 (40mg/kg) recovered 3.4 days earlier than those in the placebo group [5.4 vs. 8.8 days; 95% C.I, 5.35(3.97, 6.78) to 8.77 (6.72, 11.73), log-rank p-value= 0.0097]. Patients with pneumonia treated with CT-P59 (40mg/kg) reported shortened recovery time by 5.1 days compared to placebo [5.7 vs. 10.8 days; 95% C.I, 5.73 (4.13, 7.33) to 10.81 (6.81, N.C.)]. Moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo [6.6 vs. 13.0 days; 95% C.I, 6.64 (4.13, 11.94) to 12.97 (6.81, N.C.)]. In addition, CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo. Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported. Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo. “The data demonstrate that CT-P59 could contribute to both a reduced time to clinical recovery, as well as a reduced proportion of patients who progress to severe disease.” said Professor Joong-Sik Eom, Infectious Disease Division at Gil Medical Center of Gachon University, “The treatment’s safety profile was comparable to that of placebo and generally well-tolerated. Therefore, it is anticipated that CT-P59 would positively contribute to the management and control of the current COVID-19 pandemic across the world.” Nature Communications has published the preclinical data of CT-P59 against SARS-CoV-2, demonstrating a 100-fold reduction in the viral load of SARS-CoV-2 and improved recovery time in animal models. Additionally, the data showed encouraging results meeting several criteria from its studies; in-vitro plaque reduction neutralization test (PRNT) against SARS-CoV-2 and SARS-CoV-2 D614G variant to assess the neutralization potency of CT-P59, in-vivo efficacy in animal models to demonstrate in vivo antiviral efficacy of CT-P59, as well as in vitro antibody-dependent enhancement (ADE) assay to investigate the possible adverse effects of a COVID-19 treatment.[i] “Our top-line data from the global Phase II/III clinical trial have demonstrated that CT-P59 is effective for the treatment of COVID-19 in mild-to-moderate patients and especially in moderate patients aged 50 years and over. We are encouraged by the robust and consistent nature of the top-line clinical profile of CT-P59 and our clinical studies are on track in more than 10 countries.” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are planning to manufacture doses for around two million patients in 2021 and hope to improve access to this treatment option for those that require.” - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About CT-P59 (Regdanvimab) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.[1] 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] Celltrion Data on file [2] Kim, C., Ryu, DK., Lee, J. et al. A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun 12, 288 (2021). https://doi.org/10.1038/s41467-020-20602-5 [Last accessed January 2021]
2021-01-13
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Celltrion submits application for Conditional Marketing Authorisation of its COVID-19 treatment candidate CT-P59 to the Korean MFDS
Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate to the Korean Ministry of Food and Drug Safety (MFDS) Celltrion plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months Celltrion successfully completed its global clinical trial of CT-P59, meeting objectives of clinical endpoints; top-line data to be announced in the first half of 2021 December 29, 2020 12:28 AM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). This submission is based on the data from global Phase II/III clinical trial of CT-P59, meeting objectives of clinical endpoints. Celltrion has previously enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The top-line data of the global Phase II/III clinical trial of CT-P59 are to be presented in the first half of 2021. “Today’s filing for Conditional Marketing Authorisation in Korea is a significant milestone in the fight against COVID-19,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as early as possible.” Celltrion plans to initiate a global Phase III clinical trial, a pivotal part of the study in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59. The company plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months. - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About COVID-191,2 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1. About CT-P59 (Regdanvimab) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.3 Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.3 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 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: December 2020 2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: December 2020 3 Celltrion. Data on file
2020-12-29
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Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17
Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases The positive opinion is based on Phase I/III study data investigating the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety If approved, CT-P17 would be the first adalimumab biosimilar with high concentration (100mg/mL) and citrate-free formulation December 10, 2020 06:25 PM Eastern Standard Time 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 adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira®1, CT-P17 recommending approval for all available indications. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The EC’s decision regarding approval is expected in the first quarter of 2021, which would broaden treatment alternatives for patients suffering from rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). “If CT-P17 receives approval by the EC, Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “This portfolio expansion is in line with our mission to improve access to biologics. We aim to provide a wide range of anti-TNF treatment alternatives, together with Remsima® dual formulation in IV formulation and SC formulation, for patients suffering from chronic inflammatory diseases.” This positive opinion is based on the phase I/III studies to evaluate pharmacokinetics (PK), efficacy and safety between CT-P17 and reference adalimumab.2,3 The clinical data support the conclusion of biosimilarity of the proposed biosimilar and adalimumab to the reference product in terms of safety, efficacy, PK/PD and immunogenicity. A randomised, double-blind phase III study in RA patients demonstrating similarity in terms of efficacy, pharmacokinetics (PK) and safety, including immunogenicity up to 24 weeks was presented at the ACR Convergence 2020.4 CT-P17 met the primary objective of demonstrating equivalent efficacy and its safety profile was comparable to that of reference adalimumab. Further, a randomised, double-blind, single-dose study phase I study demonstrated PK and safety equivalence of CT-P17 in comparison to EU-approved adalimumab (EU - adalimumab) and US- licensed adalimumab (US - adalimumab) in healthy subjects up to 10 weeks. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.2 Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada said, “The CHMP positive opinion is very encouraging as CT-P17 has demonstrated promising study results in efficacy, PK and safety profile compared to reference adalimumab. Also having a high-concentration and citrate-free formulation would provide patients less pain during administration leading to improved quality of life.” The EC takes binding decisions on the authorisation of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved, the EC will grant a centralised marketing authorisation valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. - ENDS - Notes to Editors: About CT-P17 (biosimilar adalimumab) CT-P17 is the first proposed high-concentration adalimumab biosimilar. If granted authorisation, CT-P17 will be indicated for the treatment of patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. CT-P17 provides pain-reducing features as it comes with citrate-free formulation, meaning it causes less pain upon injection. 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 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 Humira is a registered trademark of AbbVie Biotechnology Ltd 2 Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020 3 National Library of Medicine (US). 2018 November - . A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis. Identifier NCT03789292. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03789292 4 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020
2020-12-11
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Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P59
Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P59 Celltrion announced enrolment completion of 327 COVID-19 patients in the global Phase II clinical trial The trial is designed to evaluate efficacy and safety of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate Celltrion intends to apply for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II clinical trial November 25, 2020 06:13 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial. The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more comprehensive safety and efficacy results of CT-P59. “We managed to successfully enrol 327 patients for the global Phase II trial and the results from the trial are expected in the coming weeks. We plan to compile a robust data set to support the planned emergency use application, expected as early as the end of the year, subject to positive study results,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “In order to respond to the global pandemic threat, we are moving forward with our clinical development with the highest urgency and as a key priority.” In an effort to further address the pandemic, Celltrion has also initiated a post-exposure prophylaxis clinical trial to evaluate the preventive effect and safety of CT-P59 and identify whether this antibody treatment candidate can elicit a neutralising antibody response to prevent the virus from infecting human cells. Celltrion is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate, ensuring potential delivery for as many as 2 million people per year globally. - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. About COVID-191,2 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1. About CT-P59 (Regdanvimab) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.3 References 1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: November 2020 2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: November 2020 3 Celltrion. Data on file
2020-11-25
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Celltrion presents efficacy and safety data for potential COVID-19 treatment candidate CT-P59 in patients with mild symptoms
Celltrion presents efficacy and safety data for potential COVID-19 treatment candidate CT-P59 in patients with mild symptoms Trial results indicate treatment with CT-P59 resulted in at least 44% faster recovery time when compared with placebo No patients treated with CT-P59 in the study have so far required hospitalisation or other antiviral therapy as a result of COVID-19 CT-P59 was well tolerated with no clinically significant safety issues seen in the study population November 05, 2020 07:16 PM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group announced results from the ongoing Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The data presented at the 2020 fall Conference of the Korean Society of Infectious Diseases on 5th November 2020, demonstrated promising safety, tolerability, antiviral effect, and efficacy profile of CT-P59 in patients with mild symptoms of COVID-19. The global Phase I clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the safety, tolerability and antiviral effect of CT-P59. The trial enrolled 18 patients with mild symptoms of SARS-COV-2 infection who were randomised into three cohorts in which 15 patients received CT-P59 at 20mg/kg, 40mg/kg or 80mg/kg respectively, or matching placebo (3 patients). The results indicate that the patient population treated with CT-P59 experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. None of the patients treated with CT-P59 required hospitalisation or antiviral therapy as a result of COVID-19. No significant treatment-emergent serious adverse events or clinically significant treatment-emergent adverse events were identified at the interim stage. “This is positive and encouraging efficacy and safety data showing accelerated recovery time in patients with mild symptoms of COVID-19,” said Professor Jin Yong Kim, Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Centre. “I look forward to the possibility of further promising data from ongoing phase II/III studies building on the positive results seen in this study.” Celltrion has previously submitted the Investigational New Drug (IND) application for the clinical trial globally, and plans to conduct further global Phase II and III trials including Korea. In addition, Celltrion has also initiated a post-exposure prophylaxis clinical trial of CT-P59 to evaluate the candidate as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients. - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us About COVID-191,2 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 About CT-P59 CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.3 References 1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: November 2020 2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: November 2020 3 Celltrion. Data on file
2020-11-06
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Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis
Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis CT-P17 is the first biosimilar with high concentration (100mg/mL) and citrate-free formulation 24-week data has shown comparable efficacy and safety data for adalimumab biosimilar CT-P17 against reference adalimumab in rheumatoid arthritis (RA)1 Comparable pharmacokinetics (PK) and safety data was also presented for CT-P17 in comparison with EU-approved adalimumab and US-licensed adalimumab in healthy subjects2 November 02, 2020 02:00 PM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--New data to be presented at the American College of Rheumatology (ACR) Convergence 2020 demonstrate that the efficacy, pharmacokinetics (PK) and overall safety of CT-P17, a proposed high concentration (100mg/mL) and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of rheumatoid arthritis (RA) patients. The randomised, double-blind, phase III study investigated the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety over 24 weeks.1 648 patients with active moderate-to-severe RA despite methotrexate (MTX) treatment were randomly assigned to receive 40mg of CT-P17 or reference adalimumab every 2 weeks up to week 24. Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab. Similar additional secondary efficacy endpoints were seen in terms of ACR20/50/70 response rates, mean DAS28 (CRP), clinical disease activity index (CDAI) and simplified disease activity index (SDAI) and EULAR (CRP) response. The PK results in terms of mean Ctrough of adalimumab up to week 24 were slightly higher for CT-P17 and the mean Ctrough was generally lower in the anti-drug antibody (ADA) positive subgroup than the ADA negative subgroup in both treatment groups. The safety profile of CT-P17 up to week 24 was comparable to that of the reference adalimumab as the majority of events were grade 1 or grade 2 in intensity.1 “These phase III results show a comparable PK, efficacy and safety profile between CT-P17 and the reference adalimumab, building on evidence demonstrating that CT-P17 is equivalent to reference adalimumab for the treatment of rheumatoid arthritis”, said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. “These promising study results support the use of CT-P17, the first adalimumab biosimilar with high concentration and citrate-free formulation as an alternative option for eligible patients with rheumatoid arthritis.” Further data presented by Celltrion Healthcare at ACR Convergence 2020 investigated the PK and safety of CT-P17 in comparison to EU-approved adalimumab (EU- adalimumab) and US- licensed adalimumab (US- adalimumab) in healthy subjects up to 10 weeks. In this phase I, randomised, double-blind, single-dose study, 312 healthy subjects aged 19 to 55 years were randomised in a 1:1:1 ratio to receive either CT-P17, EU- adalimumab or US- adalimumab after a single subcutaneous (SC) injection of 40mg (100mg/mL). The results showed that the 90% confidence intervals (CI) for the geometric least squares mean ratio of each of the primary PK parameters (AUC0-inf, AUC0-last, and Cmax) were within the predefined equivalence margin of 80% to 125%. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.2 Celltrion Healthcare also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS). As part of the study, 193 healthy subjects were randomly split into two groups to receive 40mg of either CT-P17 AI or CT-P17 PFS. Following a single SC administration of CT-P17 via AI, mean peak and total systemic exposure (AUC0-inf, AUC0-last and Cmax) were equivalent with those of CT-P17 PFS, which indicates that CT-P17 AI could be a viable alternative administration option.3 --- ENDS --- Notes to editors: About CT-P17 (biosimilar adalimumab) CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody indicated for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriasis (PsO), hidradenitis suppurativa (HS), uveitis (UV) and juvenile idiopathic arthritis (JIA). CT-P17 is the first proposed high concentration (100mg/mL) adalimumab biosimilar with citrate-free formulation, meaning it causes less pain upon injection. A phase I randomised, double-blind, three-arm, single-dose study demonstrated PK and safety equivalence of CT-P17 to the high concentration (100mg/mL), citrate-free formulation of both US- and EU- sourced reference adalimumab in healthy subjects.2 A phase III randomised, double-blind study demonstrated the equivalence efficacy to CT-P17 at week 24 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.1 A phase I, randomised, open-label, parallel group, single-dose study demonstrated PK equivalence of CT-P17 auto-injector (AI) and pre-filled syringe (PFS) in healthy subjects.3 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 endeavors 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 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 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020. 2 Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020. 3 E. Keystone, et al. (2020). A Phase 1, Randomized, Open-label, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17, a Proposed, Higher Concentration Biosimilar (100 mg/mL) Adalimumab, in Healthy Subjects. Poster Presented at ACR Convergence 2020.
2020-11-03
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Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59
Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59 The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion’s Investigational New Drug (IND) application to initiate the post-exposure prophylaxis clinical trial of CT-P59 The Phase III trial is set to enrol approximately 1,000 subjects to evaluate protective efficacy in contacts of SARS-CoV-2 infected patients Celltrion will continue to generate data from ongoing clinical trials of CT-P59 in various clinical settings October 12, 2020 10:30 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure. The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on October 8th, 2020. Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients. The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells. “We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,” said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. “We look forward to continued data generation as this trial proceeds and we remain committed to combatting the spread of the virus around the world.” Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers. The MFDS has now approved Celltrion’s IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients. - ENDS - Notes to Editors: 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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us About COVID-191,2 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 About CT-P59 CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.3 References 1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: October 2020 2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: October 2020 3 Celltrion. Data on file
2020-10-12