CelltrionHealthcare

New data show first-line triplet regimen of pembrolizumab, Herzuma® and chemotherapy are effective in treatment of HER2-positive AGC

New data show first-line triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy are effective in treatment of HER2-positive advanced gastric cancer Data from a phase Ib/II trial show a first-line triple combination therapy of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy was effective in patients with HER2-positive advanced gastric cancer (AGC)1 Patients experienced clinically significant tumour shrinkage regardless of PD-L1 status with no new safety signals observed 1 Access to a first-line immunotherapy/chemotherapy combination with Herzuma® (biosimilar trastuzumab) has the potential to improve patient outcomes whilst reducing overall treatment costs for healthcare systems FRIDAY 29TH MAY 2020– 08:01 KST, INCHEON, SOUTH KOREA – Data presented today as part of the ASCO20 Virtual Scientific Program show that a first-line triplet regimen comprising of pembrolizumab, Herzuma®(biosimilar trastuzumab)  and chemotherapy is effective in patients with HER2-positive advanced gastric cancer (AGC). The PANTHERA trial (a phase Ib/II study of first line pembrolizumab in combination with trastuzumab, capecitabine, and cisplatin in HER2-positive gastric cancer), sponsored by Celltrion Inc. and MSD, is investigating the potential of a first-line immunotherapy/chemotherapy combination with biosimilar trastuzumab. This is in light of a growing body of evidence that the immune system contributes to the therapeutic effects of monoclonal antibodies such as biosimilar trastuzumab in treating solid tumours.1 A total of 43 patients were treated with a median follow up of 18 months. Patients were treated with pembrolizumab 200mg via IV infusion D1, biosimilar trastuzumab 6mg/kg (after 8mg/kg load) D1, capecitabine 1000mg/m2  bid D1-D14 and cisplatin 80mg/m2 D1 every 3 weeks.1 The primary endpoint for phase II was the overall response rate (ORR), measured in line with the RECIST 1.1 guidelines. The results showed a significant tumour shrinkage of 95.3% with an ORR of 76.7%. Of these patients, 16.3% exhibited complete response (CR) and 60.5% partial response (PR). Furthermore, PD-L1 status at diagnosis did not have an effect on overall survival (OS) and the data also indicate a disease control rate (DCR) of 97.7%.1   Secondary endpoints for the trial included progression-free survival (PFS), OS, duration of response (DoR) and safety.  Molecular analysis was carried out through targeted next generation sequencing (NGS). The median PFS was 8.6 months (95% CI 7.2-16.4) and the median OS was 19.3 months (95% CI 16.5-NA).1  The median duration of response (DOR) was 10.8 months (95% CI 7.17-NA). Whilst carrying out the study, the investigators did not observe any new safety signals. The most common haematologic adverse events included a decreased neutrophil count, as seen in 46.5% of patients, and anaemia which was experienced by 32.6%. Other frequently reported adverse events included anorexia (39.5%) and nausea (32.6%), and the most observed immune-related adverse event was hypothyroidism (11.6%).1 “According to our study, patients with HER2-positive AGC treated with this first-line triplet regimen experienced clinically meaningful improvements in tumour shrinkage regardless of PD-L1 status,” said Professor Sun Young Rha at Yonsei Cancer Center , Yonsei University College of Medicine. “Enabling access to the first immunotherapy/chemotherapy combination with Herzuma® (biosimilar trastuzumab) in the first-line setting will make a real difference to patients.” Prof Rha added, “With the costs of oncology treatments being so burdensome, the availability of biosimilar trastuzumab could reduce the overall cost by combination treatment with innovative new drugs and chemotherapy. High quality treatments at reduced overall treatment cost could imply a benefit to health systems worldwide.”   -- ENDS --   Notes to Editors:   About metastatic (advanced) gastric cancer[1],[2],[3],[4] Gastric cancer is a leading cause of cancer-related deaths worldwide, with over a million new cases of gastric cancer diagnosed each year. HER2 overexpression has been reported in 7-34% of gastric cancers. Gastric cancer commonly begins in the inner lining of the upper part of the stomach and can spread through the walls of the stomach. The cancer can then invade other organs or spread to the lymph vessels and nodes. Gastric cancer can be staged from 0 to IV depending on its progression. As the stage number increases, the larger the cancer growth and the further the cancer has spread. Clinical trials have evaluated trastuzumab in combination with chemotherapy as first-line treatment for metastatic (advanced) gastric cancer.   About Herzuma® (biosimilar trastuzumab)[5]   Herzuma® is a humanised monoclonal antibody that is designed to bind selectively to the extracellular domain of an antigen called human epidermal growth factor reception 2 (HER2). Herzuma® is indicated for the treatment of adult patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer and was approved by the European Medicines Agency (EMA) in February 2018.   Similarity of Herzuma® to the reference product, Herceptin® was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials.   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   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] Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019;14(1):26‐38. doi:10.5114/pg.2018.80001 [2] Rüschoff J, Hanna W, Bilous M, et al. HER2 testing in gastric cancer: a practical approach. Mod Pathol. 2012;25(5):637‐650. doi:10.1038/modpathol.2011.198 [3] Kanayama K, Imai H, Usugi E, Shiraishi T, Hirokawa YS, Watanabe M. Association of HER2 gene amplification and tumor progression in early gastric cancer. Virchows Arch. 2018;473(5):559‐565. doi:10.1007/s00428-018-2433-y [4] Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial [published correction appears in Lancet. 2010 Oct 16;376(9749):1302]. Lancet. 2010;376(9742):687‐697. doi:10.1016/S0140-6736(10)61121-X [5] European Medicines Agency Summary of Product Characteristics (SmPC). Herzuma. Available at https://www.ema.europa.eu/en/documents/product-information/herzuma-epar-product-information_en.pdf Last accessed May 2020

2020-05-29

Celltrion completes neutralisation test on candidate monoclonal antibodies (mAbs) for COVID-19 antiviral antibody treatment

Celltrion completes neutralisation test on candidate monoclonal antibodies (mAbs) for COVID-19 antiviral antibody treatment ·        Celltrion completes selection of therapeutic antibodies which are most potent for neutralising the virus ·        Celltrion expects cell-line development to commence this week ·        Celltrion also plans to develop a super-antibody or an antibody cocktail therapy, to target potential mutations of SARS-CoV-2   APRIL 13 2020, 09:00 BST, INCHEON, KOREA – Celltrion Group today announced that the company has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2, the virus causing COVID-19.   Through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion initially identified and secured 300 different types of antibodies that bind to the SARS-CoV-2 antigen. These were then screened based on their ability to bind to the virus spike protein. Celltrion was then able to capture a total of 38 potent neutralising antibodies, of which, 14 are powerful neutralising antibodies against SARS-CoV-2.   Following the selection of antibody candidates which demonstrate high potency in neutralising SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody and, together with the KCDC, Celltrion will conduct efficacy and toxicity testing in mice and non-human primates.   Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “We are bringing our full resources and expertise to overcome this global health crisis and are glad to have identified these antibodies sooner than previously expected. These antibodies can recognise multiple epitopes, thus increasing the probability of neutralisation against viral mutations. Given the expedited development process of our antiviral antibody treatment, we anticipate moving to first-in-human clinical trials in July. We are also on track with the development of a ‘super antibody’ or ‘an antibody cocktail’ and the launch of a rapid diagnostic kit in the summer 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[1] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 Last accessed: April 2020

2020-04-13

Celltrion’s COVID-19 Antiviral Treatment Enters the Next Phase of Development

Celltrion’s COVID-19 antiviral treatment enters the next phase of development ·        Celltrion initiates the 2nd  stage; selecting the therapeutic antibodies which are most potent for neutralising the infection ·        Celltrion completed the 1st phase of screening 300 potential antibody candidates to treat COVID-19 ·        Celltrion aims to initiate a clinical trial in July 2020   APRIL 03 2020, 09:00 BST, INCHEON, KOREA – Celltrion Group today announced its successful transition to the second phase of development for an antiviral treatment to fight the novel coronavirus (COVID-19) pandemic, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen last month. The library of antibodies was created using the blood of recovered patients in Korea.   In cooperation with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion will be screening the antibodies to find the ones most effective in neutralising SARS-CoV-2, the virus responsible for COVID-19. Celltrion anticipates the candidate screening for the therapeutic monoclonal antibody (mAb) will be complete by mid-April, sooner than originally expected.   Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “Once we have selected the one that most effectively neutralizes the COVID-19 virus among hundreds of the screened antibodies, we will roll out mass production of the therapeutic antibody treatment, with a view to starting human trials this July. Due to the urgent need for a COVID-19 antiviral treatment, we have expedited the overall development process of our antiviral therapy to help infected patients fight this emerging virus and halt further spread of the disease.”   -       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[1] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 Last accessed: April 2020

2020-04-03

Celltrion accelerates development of COVID-19 antiviral treatment and aims to launch rapid self-testing kit

Celltrion accelerates development of COVID-19 antiviral treatment and aims to launch rapid self-testing kit Celltrion completes first step of developing an antiviral treatment to fight COVID-19 and hopes to begin human clinical trials in the third quarter of 2020  Celltrion aims to launch the rapid self-testing diagnostic kit for COVID-19 this summer: the kit is designed to provide results within 15-20 min of self-testing Leveraging its world-class expertise in biologics, Celltrion Group remains committed to supporting patients and healthcare systems throughout the pandemic MARCH 23RD 2020, 06:30 GMT, INCHEON, KOREA – Celltrion Group today announced key milestones in its efforts to fight the 2019 novel coronavirus (COVID-19) pandemic. As part of its emergency preparedness plan to address the outbreak, which has infected over 200,000 people worldwide,[1],[2] Celltrion has successfully completed the first step of developing an antiviral treatment to fight COVID-19 and aims to launch a rapid self-testing diagnostic kit that could provide results within 15-20 minutes.   Celltrion has been selected as a preferred developer for a monoclonal antibody project to treat and prevent COVID-19 by the Korea Centers for Disease Control (KCDC). Korea was one of the first countries to be affected by the global pandemic.[3] Celltrion has identified the library of antibodies sourced from the blood of recovered patients in Korea, which are thought to be involved in neutralising the virus and may contribute to recovery from COVID-19. These antibodies are undergoing further screening processes to identify those that are most effective in neutralising the virus causing COVID-19. Once identified these will form the basis of the antiviral treatment to be tested through pre-clinical and clinical trials around the world in the third quarter of 2020.   Furthermore, Celltrion plans to develop a ‘super antibody’ that can attach and neutralise all kinds of coronavirus related strains, such as those causing COVID-19 and SARS, enabling further protection against unforeseen or unexpected mutations. Celltrion hopes the ‘super antibody’ candidate could contribute towards preparedness for potential future pandemic situations.   Alongside therapeutic antibody development, Celltrion aims to launch a rapid self-testing diagnostic kit in the summer of this year. The kit will focus on the gene that encodes the surface spike (S) protein; an essential glycoprotein for viral entry into human host cells. The kit is designed to show results within 15-20 minutes, with optimised sensitivity, specificity and improved accuracy features. Once it has gained a CE mark, the rapid self-testing diagnostic kit will become available throughout Europe through Celltrion Healthcare. Celltrion plans to apply for device authorisation from the FDA in the US and other regulatory authorities after acquiring relevant data.   Ki-Sung Kwon, Head of R&D Division at Celltrion said, “Our COVID-19 antiviral treatment is designed to train the immune system to make antibodies that recognise and block the spike protein that the virus uses to enter human cells. Antibodies that bond to the COVID-19 antigen will also be used to develop a diagnostic kit. We implemented an emergency preparedness plan at the very start of the COVID-19 outbreak leveraging our unique antibody discovery, development and manufacturing technologies. We remain dedicated to supporting healthcare systems across the world and innovating to support patients throughout this pandemic.”   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-19[4] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 COVID-19 Global Cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). John Hopkins University. Available at: https://coronavirus.jhu.edu/map.html Last accessed: March 2020 [2] Novel Coronavirus (COVID-19) Situation. World Health Organization. Available at: https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd Last accessed: March 2020 [3] Novel Coronavirus – Republic of Korea (ex-China). World Health Organization. Available at: https://www.who.int/csr/don/21-january-2020-novel-coronavirus-republic-of-korea-ex-china/en/ Last accessed: March 2020 [4] Coronavirus. World Health Organizaton. Available at: https://www.who.int/health-topics/coronavirus Last accessed: March 2020

2020-03-23

Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active CD and UC

Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis presented at The European Crohn's and Colitis Organisation (ECCO) annual congress Switching and long-term results from a randomised controlled trial (RCT) showed that the subcutaneous (SC) formulation of infliximab was comparable to the intravenous (IV) formulation of CT-P13 (biosimilar infliximab) in terms of efficacy and safety in patients with active Crohn’s disease and ulcerative colitis up to week 541 The corresponding abstract and presentation were selected as one of the Highlights of ECCO at this year’s congress February 14, 2020 10:04 AM Eastern Standard Time VIENNA--(BUSINESS WIRE)--Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC). Results presented at The European Crohn's and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.1 In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (1 Professor Shomron Ben-Horin, MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, and one of the lead investigators of the trial said, “the 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV. These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.” Professor Ben-Horin added, “It is exciting to hear that the abstract has been selected as one of the Highlights of ECCO and I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months.” The study showed that the mean CDAI and partial Mayo scores decreased over time in both arms until week 30, while comparable improvement in clinical activity was observed at week 54 - after switching the remaining IV patients to SC. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in CD and UC combined was further improved at week 54. Furthermore, after switching the mean pre-dose serum concentrations in the IV arm increased to a comparable level as the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, were comparable between both the SC and IV arms.1 The results were presented as part of oral presentation ‘OP24: 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’, which was selected for inclusion in the Highlights of ECCO by organisers. “CT-P13 SC (Remsima® SC) is the first and only subcutaneous infliximab to be available in Europe offering patients who are starting or switching anti-TNF-α therapy with the proven benefits of infliximab in a more convenient form. Starting with Germany, we have started launching the new subcutaneous infliximab country by country by establishing local operations across major European countries, building our commercial capabilities and strengthening our relationships with stakeholders across these markets” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. Celltrion is seeking approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC (Remsima® SC) in mid-2020, following EU marketing authorisation for the treatment of people with rheumatoid arthritis in late 2019. --- ENDS --- Notes to editors: About inflammatory bowel disease Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.2 They affect an estimated 5 million people globally;3 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.4 About CT-P13 (biosimilar infliximab)5,6,7 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 U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of February 2020) including the US, Canada, Japan and throughout Europe. CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that 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. CT-P13 SC has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. Celltrion has submitted a further variation to the marketing authorisation of CT-P13 SC to extend the indication to other disease areas including inflammatory bowel disease. In the United States, Remsima® SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval by 2022. 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 References 1 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. 2 Molodecky, N. A, et al. (2012). Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed February 2020]. 3 The European Federation of Crohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science Retrieved from www.efcca.org/en/science [Last accessed February 2020]. 4 Burisch, J, et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrieved from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed February 2020]. 5 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019. 6 Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019. 7 European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed February 2020].

2020-02-14

‘First Mover to Game Changer’: Celltrion announces 2020-2030 strategy at the 38th J.P. Morgan Healthcare Conference

‘FirstMover to Game Changer’: Celltrion announces 2020-2030  strategy at the 38thJ.P. Morgan Healthcare Conference   ·       Celltrion’s Chairman JungJin Seo announced the company’s strategy for the upcoming decade including itsbiosimilar, bioinnovative and new drug portfolio JANUARY 15th 2020, 16:00 PST, SAN FRANCISCO, USA – Celltriontoday announced the company’s vision for the next decade at the 38th AnnualJ.P. Morgan Healthcare Conference in San Francisco, USA. Celltrion’s ChairmanJung Jin Seo outlined the company’s strategic transition: Celltrion expects to transformfrom a ‘first mover’ to a ‘game changer’ by 2030. Celltrion’sstrategy is anticipated to differentiate the company in the biosimilarslandscape, building on its existing portfolio of treatments, including valueadded medicines or bioinnovatives such as Remsima® SC, the world’sfirst subcutaneous formulation of infliximab. Remsima® SC has thepotential to offer an alternative personalised and convenient treatment optionand was approved by the European Commission for patients with rheumatoidarthritis in November 2019. Celltrion Healthcare, the distribution arm ofCelltrion, has also applied for a further extension to the marketingauthorization of Remsima® SC, to include the inflammatory boweldisease indication. This approval decision is expected in mid-2020. JungJin Seo, Celltrion’s Chairman, said ‘‘Celltrion boasts a strong and dynamic productportfolio and pipeline. As we chart the company’s 2030 vision, the companyhopes to launch one biosimilar product every year, reaching a total number of 18products by 2030. Biosimilars and value added medicines which we call ‘bioinnovatives’(innovative biosimilars) are set to be our key growth drivers in 2020. We planto enter the new drugs and ubiquitous-healthcare business sector towards 2030.” Celltrionexpects a number of significant factors will positively influence biosimilaruptake and the company’s growth in the coming years, including healthcarebudgetary pressures; growing demand for low-cost alternative medicines and anincrease in prescriptions for biologics. These factors have played a role inthe growth of the biosimilar industry in recent years. Celltrion’s Chairman highlightedthat increasingly positive sentiment from key stakeholders has contributed toCelltrion Healthcare’s growth in sales over the course of 2019 and is set tocontinue. Asdemonstrated by the findings of a recent report from healthcare consulting firmIQVIA[i], the company’s marketshare in major European markets has continued to grow. Remsima®, theworld’s first approved monoclonal antibody biosimilar has continued to overtakethe market share of its reference drug, Janssen’s Remicade®, withRemsima® owning 59% of the market. Celltrion has also seen growth inthe uptake of its rituximab biosimilar, Truxima® and trastuzumabbiosimilar, Herzuma®, with their market shares reaching 38% and 15%respectively. These figures place Truxima® and Herzuma®as the leading biosimilars in terms of market share within the rituximab andtrastuzumab markets. HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcaresaid, “As a ‘first mover’, CelltrionHealthcare has gained extensive experience in the biopharmaceutical field andis now ready to initiate a direct sales model. Celltrion Healthcare has set upits own sales network and overseas offices in 14 countries throughout Europe tosecure price competitiveness, and strives to lead the global tumour necrosisfactor alpha (TNF-α)inhibitors market with its innovative infliximab Remsima® SC, whichis projected to be worth approximately $50 billion.” As Celltrion enters the next decade, itsambitions reach beyond biosimilars and into new drug development. At theconference, Jung Jin Seo also outlined the company’s new drug development plan whichis set to combine new platform technology and drug repositioning. This platformtechnology - the Antibody Delivery Enhancing Domain -  is designed to increase the deliveryefficiency of antibody-drug conjugates and their cell penetration, which hasthe potential to enhance cancer treatments . The company is set to create a newparadigm following innovation trends throughout the healthcare sector from 2020to 2030.   - ENDS -   Notes to Editors: About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordablemedications to promote patients’ access to advanced therapies. Its products aremanufactured at state-of-the-art mammalian cell culture facilities, designedand built to comply with the US FDA cGMP and the EU GMP guidelines. CelltrionHealthcare endeavours to offer high-quality cost-effective solutions through anextensive global network that spans more than 120 different countries. For moreinformation please visit: https://www.celltrionhealthcare.com/en-us About CT-P13 (biosimilar infliximab)[ii],[iii],[iv] CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’sfirst monoclonal antibody biosimilar approved by the European Commission (EC).It is indicated for the treatment of eight autoimmune diseases including RA andIBD. It was approved by the EC under the trade name Remsima® inSeptember 2013 and launched in major EU countries in early 2015. The U.S. Foodand Drug Administration approved CT-P13 in April 2016 under the trade nameInflectra®. CT-P13 is approved in more than 89 countries (as of January 2020) including the US, Canada, Japan and throughout Europe. CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mgper kg/body weight for the other indications. Infliximab IV is given as aninfusion over two hours. All patients are monitored for any reactions duringthe infusion and for at least one to two hours afterwards. Celltrion has alsodeveloped a subcutaneous (SC) formulation of infliximab that has threeadministration options; via a pre-filled pen (auto injector), pre-filledsyringe or pre-filled syringe with needle safeguard. The SC formulation has thepotential to enhance treatment options for the use of infliximab biosimilar byproviding high consistency in drug exposure and a convenient method ofadministration. CT-P13 SC has received a positive opinion from the Committee for MedicinalProducts for Human Use (CHMP) and EU marketing authorisation for the treatmentof people with RA. A phase III study of CT-P13 SC for people with inflammatorybowel disease (IBD) is underway. Celltrion has submitted a further variation tothe marketing authorization of CT-P13 SC to extend the indication toinflammatory bowel disease. In the United States, Remsima® SCwill be reviewed through the new drug pathway with the expectation of receivingUS Food and Drug Administration (FDA) approval by 2022. About ‘bioinnovatives’   ‘Bioinnovatives’ are defined by Celltrion Healthcare as ‘innovativebiosimilars’. The term derives from the combination of the words ‘biosimilar’and ‘innovation’.   While biosimilars, as the term suggests, aim to establish similarityto a known biologic; Celltrion Healthcare considers ‘bioinnovatives’ as ‘valueadded medicines’. Medicines for Europe define ‘value added medicines’ as biosimilarswhich address additional healthcare needs and deliver relevant improvements forpatients, healthcare professionals and/or payers. The ‘added value’ may beachieved through finding a new indication (drug repositioning), finding abetter formulation or dosage (drug reformulation), or developing a combineddrug regimen, adding a new device or providing a new service (drugcombination). Relevant improvements include: a better efficacy, safety and/ortolerability profile; a better method of administration and/or ease of use; andnew therapeutic uses (indication/population).[v]   References [i] IQVIA WRP 2019.Data on File. [ii] Yoo DH, Jaworski J, Matyska-Piekarska Eet al. A Novel Formulation of CT-P13(Infliximab Biosimilar) for Subcutaneous Administration: One Year Results fromPart One of a Phase I/III Randomised Controlled Trial in Patients withRheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019. [iii] Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13(Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results fromPart Two of a Phase I/III Randomised Controlled Trial in Patients withRheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019. [iv] European Medicines Agency Summary ofProduct Characteristics (SmPC). CT-P13. Available athttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf[Last accessed January 2020]. [v] EuropeanMedical Advisory Board on Value Added Medicines. Perceptions andrecommendations of physicians/ KOLs on value added medicines. 2019. Availableat  https://www.medicinesforeurope.com/wp-content/uploads/2019/11/Advisory-board_report-exec-summary_final.pdf [Last accessed January 2020]

2020-01-16

Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC™, for the treatment of p

Celltrion Healthcare receives EU marketing authorisation forworld’s first subcutaneous formulation of infliximab, Remsima SC™, for thetreatment of people with rheumatoid arthritis ·       Remsima SC™ is thesubcutaneous version of Celltrion Healthcare’s infliximab biosimilar, CT-P13 ·       European Union (EU) marketingapproval is based on the phase I/III study to evaluate pharmacokinetics,efficacy and safety between CT-P13 SC and the intravenous (IV) version ofCT-P13 in people with active rheumatoid arthritis (RA) ·       Thisnovel formulation provides analternative administration option for European physicians and their patients November25, 2019 07:43 PM Eastern Standard Time INCHEON,SOUTH KOREA -  Celltrion Healthcare todayannounced that the European Commission has approved Remsima SC™(CT-P13 SC, biosimilar infliximab) for patients with RA.[1] Remsima SC™ is the world’sfirst subcutaneous formulation of infliximab. Remsima SC™ is approved in theEU for the treatment of people with rheumatoid arthritis in combination withmethotrexate (MTX), in adult patients with active RA when the response todisease-modifying anti-rheumatic drugs (DMARDs), including MTX, has beeninadequate; and in adult patients with severe, active and progressive diseasenot previously treated with MTX or other DMARDs.1 The approval is based onclinical evidence including results from a study that showed switching people withRA from the intravenous (IV) formulation to the subcutaneous (SC) formulationof CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up toWeek 54 (up to Week 64 for safety profile).[2] The study was presented atthis year’s American College of Rheumatology Congress. “The approval of Remsima SC™in Europe gives patients the opportunity to administer the treatment themselvesas an injection, giving them more control over their own treatment”, said ProfessorRene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium.“Remsima SC™ has been shown to have a stable potency, and patients with RA on RemsimaSC™ develop fewer anti-drug antibodies - which can improve the effectiveness ofa treatment - compared with those on CT-P13 IV”. With the availability of thenovel formulation of infliximab, patients could now be treated with a more personalizedand convenient treatment option. Remsima SC™ can be injected by patientsthemselves, which has the potential to significantly reduce hospital visits, aswell as save time normally required for hospital-administered IV treatment. Celltrion has also submitted afurther variation to the marketing authorization of Remsima SC™ to extend theindication to inflammatory bowel disease and the approval decision is expected inmid-2020. “The development of Remsima SC™demonstrates that Celltrion Healthcare is not just a biosimilar company, it isalso an innovative company that strives for novel solutions such as the SCformulation of biosimilar infliximab. We develop cost-effective and patient-centeredtreatments to enable more patients to gain access to biologics that have provenefficacy and safety profiles,” said Hyoung-KiKim, Vice Chairman at Celltrion Healthcare. “Celltrion Healthcare has expandedits business operations to strengthen the company’s presence in the majorEuropean markets. Celltrion expects to launch Remsima SC™ across Europe in the first quarter of 2020”. Celltrion has applied forpatent protection, until 2038, for Remsima SC™ in approximately 100 countries throughoutthe US, Europe and Asia. -- ENDS -- Notes to Editors: About CT-P13 (biosimilar infliximab)1,[3],[4],[5] CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’sfirst monoclonal antibody biosimilar approved by the European Commission (EC).It is indicated for the treatment of eight autoimmune diseases including RA andIBD. It was approved by the EC under the trade name Remsima® inSeptember 2013 and launched in major EU countries in early 2015. The U.S. Foodand Drug Administration approved CT-P13 in April 2016 under the trade nameInflectra®. CT-P13 is approved in more than 89 countries (as of November2019) including the US, Canada, Japan and throughout Europe. CT-P13 IV is usually given as 3mg per kg/body weight in RAand as 5mg per kg/body weight for the other indications. Infliximab IV is givenas an infusion over two hours. All patients are monitored for any reactionsduring the infusion and for at least one to two hours afterwards. Celltrion hasalso developed a subcutaneous (SC) formulation of infliximab that has threeadministration options; via a pre-filled pen (auto injector), pre-filledsyringe or pre-filled syringe with needle safeguard. The SC formulation has thepotential to enhance treatment options for the use of infliximab biosimilar byproviding high consistency in drug exposure and a convenient method ofadministration. CT-P13 SC has received a positive opinion from theCommittee for Medicinal Products for Human Use (CHMP) and EU marketingauthorisation for the treatment of people with RA. A phase III study of CT-P13SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hassubmitted a further variation to the marketing authorization of CT-P13 SC toextend the indication to inflammatory bowel disease. About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordablemedications to promote patients’ access to advanced therapies. Its products aremanufactured at state-of-the-art mammalian cell culture facilities, designedand built to comply with the US FDA cGMP and the EU GMP guidelines. CelltrionHealthcare endeavours to offer high-quality cost-effective solutions through anextensive global network that spans more than 120 different countries. For moreinformation please visit: https://www.celltrionhealthcare.com/en-us References [1] European Medicines AgencySummary of Product Characteristics (SmPC). Remsima SC™. [2] Westhovens R, Wiland P,Zawadzki M et al. Efficacy and Safetyof a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Periodand After Switching from Intravenous CT-P13 in Patients with Active RheumatoidArthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial[abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).Available at:https://acrabstracts.org/abstract/efficacy-and-safety-of-a-novel-subcutaneous-formulation-of-ct-p13-over-the-1-year-treatment-period-and-after-switching-from-intravenous-ct-p13-in-patients-with-active-rheumatoid-arthritis-results-fro/.[Last accessed November 2019]. [3] Yoo DH, Jaworski J,Matyska-Piekarska E et al. A NovelFormulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration:One Year Results from Part One of a Phase I/III Randomised Controlled Trial inPatients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019. [4] Westhovens R, Wiland P,Zawadzki M et al. A Novel Formulationof CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-weekResults from Part Two of a Phase I/III Randomised Controlled Trial in Patientswith Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019. [5] European Medicines AgencySummary of Product Characteristics (SmPC). CT-P13. Available athttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf[Last accessed November 2019].

2019-11-26

New data show non-inferiority of efficacy for subcutaneous formulation of CT-P13 (biosimilar infliximab) to intravenous formulation of CT-P13 in peopl

New data show non-inferiority of efficacy for subcutaneous formulation of CT-P13 (biosimilar infliximab) to intravenous formulation of CT-P13 in people with rheumatoid arthritis · The results after switching from intravenous (IV) to subcutaneous (SC) treatment at Week 30 were comparable with that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile)1 · The study showed CT-P13 SC achieved a sustained mean serum concentration and demonstrated a comparable efficacy profile; CT-P13 SC could provide a benefit to patients with an alternative, convenient way of administration 1 · Celltrion Healthcare also presented data from the first-in-human study of CT-P17, a recombinant humanised monoclonal antibody that was developed as a biosimilar to the reference product, adalimumab2 November 09, 2019 04:30 PM Eastern Standard Time ATLANTA--(BUSINESS WIRE)--Celltrion Healthcare today announced data, at the American College of Rheumatology (ACR) annual meeting, from a study further investigating the efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC over a one-year treatment period and after switching from CT-P13 IV to CT-P13 SC in people with rheumatoid arthritis (RA).1 A previous study demonstrated the non-inferiority of CT-P13 SC to CT-P13 IV and compared the efficacy, pharmacokinetics and safety profiles of CT-P13 SC with CT-P13 IV in people with RA over 30 weeks.3 People who received full doses of CT-P13 IV 3 mg/kg at Weeks 0 and 2 were randomly assigned to receive either CT-P13 SC 120 mg via pre-filled syringe biweekly (from Week 6 to Week 28) or CT-P13 IV 3mg/kg every 8 weeks (from Week 6 to Week 22). From Week 30 all people received CT-P13 SC 120 mg via pre-filled syringe biweekly up to Week 54.1 The efficacy up to Week 54 showed a similar trend between CT-P13 SC and CT-P13 IV arms even after switching from IV to SC treatment at Week 30 in terms of DAS28 (CRP) mean scores, ACR20/50/70 and EULAR-CRP response.1 In the CT-P13 SC arm, the mean serum concentration before study drug administration increased from Week 6 and generally maintained a consistent level from Weeks 14 to 54 as a result of biweekly CT-P13 SC injections. After switching from IV to SC at Week 30, the mean serum concentration gradually increased from Week 30 and maintained a consistent level up to Week 54.1 The results after switching from IV to SC treatment at Week 30 were comparable to that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile). The proportion of people who had anti-drug antibody (ADA) positive results and had post-treatment ADA positive results were comparable between the two arms and numerically lower in the CT-P13 SC arm.1 “Non-inferiority of efficacy for CT-P13 SC to CT-P13 IV was demonstrated by the change from baseline DAS28 (CRP) at Week 22. The serum concentration of CT-P13 SC was well maintained up to Week 54. Safety results of CT-P13 SC showed similar profiles to CT-P13 IV during the study,” said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. “Hence, CT-P13 SC showed lower ADA than CT-P13 IV which indicates high trough level potentially leading to better PK pattern and positive efficacy profile. The results show that the novel SC formulation of CT-P13 via pre-filled syringe could provide a favourable benefit to people with an alternative convenient way of administration.” Celltrion Healthcare also announced data from a first-in-human study of CT-P17, a recombinant humanised monoclonal antibody developed as a biosimilar to the reference product adalimumab. The study was designed to evaluate the safety, including immunogenicity and pharmacokinetics, of CT-P17 (40 mg/0.4 mL) compared with EU-reference adalimumab (40 mg/0.4 mL) in healthy male subjects.2 In this phase 1, randomised, double-blind, active comparator study, healthy male subjects aged 18 to 55 years (N = 30) were randomised in a 1:1 ratio to receive 40 mg of either CT-P17 or EU-reference adalimumab by SC injection. Single SC doses of 40 mg of CT-P17 or EU-reference adalimumab were well-tolerated and the safety profile of CT-P17, including immunogenicity, was comparable with that of EU-reference adalimumab in these healthy male subjects. “Overall, the proportion of subjects with positive ADA and neutralising antibodies results after the study drug administration was similar in the two treatment groups,” said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. “Pharmacokinetic results were also comparable between the two treatment arms.” Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare, said, “With the availability of the CT-P13 SC, patients could now be treated with infliximab SC before switching to other costly antibodies with a different mechanism of action such as JAK-inhibitors. Celltrion Healthcare will target CT-P13 SC as the preferred agent for second-line treatment in rheumatoid arthritis. Together with the subcutaneous formulation of CT-P13, the development of the biosimilar adalimumab, CT-P17, will offer opportunities in improving access to treatment and increasing treatment options worldwide. Celltrion Healthcare remains highly committed to developing our biosimilar portfolio and delivering value to patients, payers and healthcare providers.” -- ENDS -- Notes to Editors: 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 intravenous (IV) formulation is approved in more than 91 countries (as of October 2019) including the US, Canada, Japan and throughout Europe.  CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.4 Celltrion has also developed a subcutaneous (SC) formulation of infliximab that 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.5,6 The SC formulation of CT-P13 is not currently approved for us. It has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of people with RA. A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hope to seek expanded indications following the results of this trial. About CT-P17 (biosimilar adalimumab) CT-P17 is a recombinant humanised 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). The primary results of the first clinical study of CT-P17 – a phase 1 randomised, double-blind, three-arm, parallel group, single-dose study versus reference adalimumab in healthy male subjects – were recently published and demonstrated comparability in safety profile, immunogenicity and pharmacokinetics (PK) for these healthy male subjects. About Celltrion Healthcare Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us Forward-looking statement disclaimer Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.  Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this presentation are based upon what management of Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. References   1   Westhovens R, Wiland P, Zawadzki M et al. Efficacy and Safety of a Novel Subcutaneous Formulation of     CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial. Poster Number 0548. Presented at ACR 2019.   2   Keystone E, Furst D, Boyce M et al. A Pilot Phase 1, Randomized, Double-blind, Two-arm, Parallel Group,     Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P17 and Humira in Healthy Male Subjects. Poster Number 0503. Presented at ACR 2019.   3   Westhovens R, et al. SAT0170 A novel formulation of CT-P13 for subcutaneous administration: 30 week     results from a part 2 of phase phase i/iii randomised controlled trial. Ann Rheum Dis 2019;78:1158-1159.   4   European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at     http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002576/WC500150871.pdf [Last accessed November 2019].   5   Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for     Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019.   6   Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for     Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019. Contacts Emma Gorton egorton@hanovercomms.com +44 (0)20 3817 6591 Sophia Eminson seminson@hanovercomms.com +44 (0)20 3817 6583

2019-11-09

New subcutaneous formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) shows positive Phase 1 results for the treatment of IBD in data

New subcutaneousformulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) showspositive Phase 1 results for the treatment of IBD in data presented at UEGWeek Barcelona 2019 · Results from a multicentre, open-label, randomised Phase 1, pivotal study showed that the  subcutaneous (SC) formulation of CT-P13 (biosimilar infliximab) was non-inferior to intravenous (IV) formulation of CT-P13 in terms of pharmacokinetics in inflammatory bowel disease patients at week 22 ·  CT-P13 SC also showed comparable efficacy and safety to CT-P13 IV for patients with Crohn’s disease (CD) and ulcerative colitis (UC) up to week 30 · Novel subcutaneous formulation could provide an alternative administration option for physicians and their patients   MONDAY 21STOCTOBER 2019 – BARCELONA, SPAIN – Celltrion Healthcare today announced new data from a Phase 1 pivotal study to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 SC compared to the CT-P13 IV formulation in people with inflammatory bowel disease (IBD). Results presented at UEG Week 2019 in Barcelona, Spain demonstrated non-inferiority of CT-P13 SC compared to CT-P13 IV in the PK primary endpoint at pre-dose level (Ctrough) at week 22, and in the secondary endpoints efficacy and safety up to week 30.  In the study, 136 patients were enrolled and 131 were randomised (66 to CT-P13 SC and 65 to CT-P13 IV). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either CT-P13 SC 120mg ( The Phase 1 pivotal study demonstrated that CT-P13 SC showed non-inferiority in PK to CT-P13 IV as determined by the trough concentration, pre-dose level (Ctrough) at week 22. In terms of efficacy, both clinical response and remission in patients were induced and maintained, and the overall efficacy results of CT-P13 SC were comparable. The combined clinical remission rates for CD and UC patients at week 30 were comparable between CT-P13 IV and CT-P13 SC (66.7%, 44 out of 66 patients in CT-P13 SC arm and 54.7%, 35 out of 64 patients in CT-P13 IV, p=0.1620). The safety profile of CT-P13 SC was comparable to CT-P13 IV. In addition, fewer patients were found to have positive anti-drug-antibodies with CT-P13 SC compared to CT-P13 IV.   A subcutaneous formulation of CT-P13 has the potential to enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration. “CT-P13, a biosimilar of infliximab, has already been thoroughly characterized as a prime choice for intravenous infliximab therapy in the past with dedicated trials demonstrating clinical similarity in comparison with the originator molecule in both RA and IBD. The new, highly innovative SC formulation of infliximab has been specifically developed to address unmet needs in maintenance therapy.  Our results from the ongoing development program for SC CT-P13 infliximab are promising. CT-P13 SC infliximab has the potential to become the most innovative  biosimilar treatment – improving convenience and allowing patients to have more control of their treatment in addition to direct clinical benefits,” said Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany and first author of the study. “Not without reason the IV/SC sequence therapy that has been implemented into most development paths for novel molecules.” “A new subcutaneous formulation of infliximab has the potential to change the way patients manage their condition on a day-to-day basis, offering them greater choice and convenience in the long term. Furthermore, offering patients the option to self-administer will reduce demand on healthcare systems, by lessening patient time spent in hospitals, keeping patients out of clinics and providing clinicians with additional time to spend with other patients,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “This new formulation could create a new treatment paradigm with IV/SC sequence therapy making treatment affordable, convenient and personalised.” Celltrion seeks approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC in the second half of 2020. --- ENDS ---   Notes to editors:   About inflammatory bowel disease Inflammatory boweldiseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronicdisabling gastrointestinal disorders that impact every aspect of a patient’slife.[1] They affect an estimated 5 millionpeople globally;[2]IBDs account for substantial costs to the healthcare system and society; the direct healthcarecosts of IBDs are estimated to be €4.6-5.6 billion per year.[3] About CT-P13 (biosimilar infliximab) CT-P13 is developed and manufacturedby Celltrion, Inc. and was the world’s first monoclonal antibody biosimilarapproved by the European Commission (EC). It is indicated for the treatment ofeight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013and launched in major EU countries in early 2015. The US FDA approved CT-P13 inApril 2016 under the trade name Inflectra®. CT-P13 is approved inmore than 89 countries (as of October 2019) including the US, Canada,Japan and throughout Europe. About Celltrion Healthcare Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: : http://www.celltrionhealthcare.com/   References [1] Molodecky, N. A, et al. (2012).Increasing incidence and prevalence of the inflammatory bowel diseases withtime, based on systematic review. Gastroenterology, 142(1), 46-54. Retrievedfrom: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed October 2019]. [2] The European Federation ofCrohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science Retrievedfrom www.efcca.org/en/science [Last accessed October 2019]. [3] Burisch, J, et al. (2013). Theburden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis,7(4), 322-337.Retrived from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed October 2019].

2019-10-18

Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people w

Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people with rheumatoid arthritis CT-P13 subcutaneous (SC) (biosimilar infliximab) recommended by CHMP for European Union (EU) marketing authorisation to treat rheumatoid arthritis (RA) CHMP positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version of CT-P13 in people with active RA Novel formulation provides an alternative administration option for physicians and their patients CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the EU September 22, 2019 07:01 PM Eastern Daylight Time INCHEON, SOUTH KOREA - Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for CT-P13 SC for marketing authorisation in the European Union (EU) in people with rheumatoid arthritis (RA). CT-P13 SC is the subcutaneous version of Remsima® (biosimilar infliximab, CT-P13). This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines in the EU. A subcutaneous formulation has the potential to enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration.1,2 “Today’s positive CHMP opinion brings us one step closer to providing a personalised treatment approach for people living with rheumatoid arthritis. This marks an important milestone for our business providing people with a new route of administration, and a novel formulation of infliximab,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “If approved, we will begin a new era in the biotherapeutic class, as CT-P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients.” This positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version in people with active RA. Part one of the study demonstrated that CT-P13 SC showed comparable efficacy to CT-P13 IV up to week 54 with comparable DAS28 (CRP) / DAS28 (ESR) and ACR20 scores (measures of disease activity) demonstrated for both routes of administration. The safety profile of CT-P13 SC was also comparable to CT-P13 IV.[1] The study was followed up by a phase I/III randomised controlled trial (part two) which demonstrated non-inferiority in efficacy of CT-P13 SC to CT-P13 IV in people with RA over 30 weeks with similar DAS28 and ACR20, ACR50, ACR70 scores and EULAR-CRP response. The safety profile of CT-13 SC was comparable to CT-13 IV up to week 30.[2] Global Principal Investigator Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium said, “This announcement is very encouraging as CT-P13 SC has demonstrated a comparable safety and efficacy profile to the well-established intravenous version of infliximab. This new SC formulation of infliximab could give patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment. Having two formulations of CT-P13 could also benefit patients by offering a more personalised treatment option whilst also reducing the time spent in hospital having intravenous treatment alone.” A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hope to seek expanded indications following the results of this trial. Celltrion Healthcare will adopt a different business strategy for CT-P13 SC, compared to strategies for previous products in the portfolio and is considering both direct and indirect sales based on the optimal model in each local country. Celltrion has applied for a patent for CT-P13 SC in approximately 130 countries throughout the US, Europe and Asia.   -- ENDS -- Notes to Editors: About CT-P13 intravenous (IV) formulation[3] CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.   About CT-P13 subcutaneous (SC) formulation1,2 CT-P13 SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.   About CT-P13 (biosimilar infliximab) CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 89 countries (as of September 2019) including the US, Canada, Japan and throughout Europe. About Celltrion Healthcare Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/ Forward-looking statement 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] Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019. [2] Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019. [3] European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed September 2019].    

2019-09-22