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noimage European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indic 2020-07-27

European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis The European Union (EU) marketing authorisation for the subcutaneous (SC) formulation of Remsima® (CT-P13) now applies to all previously approved indications for the intravenous (IV) formulation in adult patients including: ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis (PsO) The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the IV and SC formulations of Remsima® in people with active CD and UC Celltrion’s Remsima® SC is the first and only infliximab to have both IV and SC formulations; Remsima® SC reduces treatment time to approximately 2-5 minutes, with a comparable efficacy and safety profile to the IV formulation of Remsima® July 27, 2020 07:38 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.1 The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima® in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.2,3 Based on the results of the pivotal study, a 120 mg fixed dose of Remsima® SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: “The subcutaneous formulation of Remsima® (Remsima® SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Today’s approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.” “We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We will do our best to make Remsima® SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.” Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe. -- 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) formulation4,5A 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 94 countries (as of July 2020) 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 Forward-looking statement disclaimerCertain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare, that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this presentation are based upon what management of Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. References 1 European Medicines Agency Summary of Product Characteristics (SmPC). Remsima. 2 Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103. 3 Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020. 4 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. 5 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.

noimage Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results 2020-07-17

Celltrion launches human clinical trial of potential COVID-19 antiviral antibody treatment following positive pre-clinical results ·        The Phase I study of Celltrion’s COVID-19 antiviral antibody treatment candidate in healthy volunteers is set for completion by Q3 this year ·        Celltrion’s COVID-19  antiviral antibody treatment candidate has been proven to be effective in neutralising different kinds of coronavirus related strains including the mutated G-variant strain of SARS-CoV-2 (D614G variant) ·        Further human studies across Europe including the UK are planned – the company anticipates promising preliminary results from pivotal studies in mild and moderate COVID-19 patients by the end of the year   JULY 17th 2020, INCHEON, KOREA – Celltrion Group today announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure. The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital.  The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year. Celltrion is set to conduct a further in-human Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK,which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates promising preliminary results from pivotal studies by the end of the year. In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The top line data for this trial is anticipated in Q1 of 2021. Furthermore, Celltrion has previously demonstrated its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain (D614G variant),[1] which is associated with the increased viral transmission and wide spread of COVID-19.[2] “The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Dr. Sang Joon Lee,Senior Executive Vice President of Celltrion. “We were encouraged by the positive safety and efficacy results in our pre-clinical studies, and we are now ready to move into in-human clinical trials as we originally planned. We remain committed to carrying out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year.” -       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 COVID-19[3],[4] 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.   There are currently no specific vaccines or treatments approved for 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   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 usesuch 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 causeactual 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] Data on file. Celltrion Healthcare [2] Newer variant of COVID-19–causing virus dominates global infections. Los Alamos National Laboratory. Available at https://www.lanl.gov/updates/sars-cov-2-variant.php Last accessed: July 2020 [3] Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: July 2020 [4] Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: July 2020