WASHINGTON--(BUSINESS WIRE)--Jun 5, 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.”

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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 3. They affect an estimated 5 million people globally 4; 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.

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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.

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PUB: 06/05/2018 09:36 AM/DISC: 06/05/2018 09:36 AM

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