New subcutaneous formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) shows positive results for the treatment of active Crohn’s disease in data presented at Digestive Disease Week® 2018
Celltrion Healthcare today presented new research at Digestive Disease Week® (DDW) 2018, that shows the efficacy and safety of the CT-P13 subcutaneous (SC) formulation is comparable to the CT-P13 intravenous (IV) formulation up to week 30 in patients with active Crohn’s disease (CD). The results demonstrate the potential of CT-P13 SC to enhance the treatment options available for patients treated with infliximab.1
The open- label, randomised, controlled, phase I study aimed to find the optimal dose of CT-P13 SC by establishing pharmacokinetic (PK) comparability to CT-P13 IV dosing. The study also evaluated the efficacy and safety of CT-P13 SC over the first 30 weeks in patients with active CD compared to that of CT-P13 IV. 1
Patients with active CD were randomly assigned into four cohorts for the study; one group receiving CT-P13 IV (5mg/kg, Weeks 6, 14, 22 and 30) and the other three receiving different bi-weekly doses of CT-P13 SC (120mg/180mg/240mg). The 30-week results from the study showed comparable efficacy of CT-P13 SC to CT-P13 IV with a similar rate of clinical remissions and changes from baseline of CDAI, CDAI-70 and CDAI-100 scores - standardised disease improvement measurements used to quantify the symptoms of active CD. The safety profiles observed for CT-P13 SC after randomisation were also comparable to CT-P13 IV. Pharmacokinetics and pharmacodynamics modelling on the results suggested a similar dosing of CT-P13 SC to CT-P13 IV in active CD. 1
Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “Together with CT-P13 IV, CT-P13 SC marks a significant milestone for Celltrion Healthcare and our partners. This kind of innovation will enable us to differentiate our portfolio and provide a more convenient and accessible treatment administration option to patients with chronic conditions like IBD in the United States.”
Improving Patient Access in the United States
Up to 3 million people in the United States are affected by IBD, which includes CD and ulcerative colitis (UC)2. Many biologic products have improved the outcomes of patients with IBD, but the costs can substantially burden healthcare systems.
President Donald J. Trump’s recent blueprint includes new actions and proposals to drive down drug prices for all Americans, one being to advance biosimilars to boost price competition and drive reductions in price which will have a significant impact on increasing patient access to effective treatments.
Dr Edmund Pezalla, Former Vice President, Aetna, U.S., said, “The efficient and effective management of inflammatory bowel disease is crucial to patients’ long-term well-being. Biosimilars could offer patients and physicians increased access to a high-quality, lower-cost therapeutic alternative. It is critical to increase education and adopt policies that support the entrance of biosimilars so that patients can have better access to these safe, effective and more cost-efficient medicines in the U.S.”
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 life3. They affect an estimated 5 million people globally4; CD affects about three people per 1,000 and UC about 5 people per 1,000.2
IBD accounts for substantial costs to the healthcare system and society; the direct healthcare costs of IBD is estimated to be €4.6-5.6 billion per year.5
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 rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major European 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 87 countries (as of May 2018) 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/
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place June 2-5, 2018, at Walter E. Washington Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
1 Schreiber S, et al. Novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: Initial results from a phase I open-label randomized controlled trial in patients with active Crohn’s disease. Presentation number Tu2018. Digestive Disease Week (DDW) 2018.
2 Centers for Disease Control and Prevention. Inflammatory Bowel Disease Prevalence (IBD) in the United States. Available at: https://www.cdc.gov/ibd/data-statistics.htm.
3 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54.
4 The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Available at: http://www.efcca.org/en/science.
5 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 11:00 | Pressemelding
Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines
Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 08:10 | Pressemelding
Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest
Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13 | Pressemelding
Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00 | Pressemelding
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41 | Pressemelding
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00 | Pressemelding
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i