Business Wire

Celltrion Healthcare Present 1-year Results for CT-P13 (Biosimilar Infliximab, Remsima®/ Inflectra®) Switching Study in Crohn’s Disease

Jaa

Today at the 25th United European Gastroenterology Week Congress, Celltrion Healthcare presented data from the phase III, randomised controlled, switching trial comparing CT-P13 and reference infliximab. The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.1

The trial investigated the efficacy and safety of CT-P13 throughout a 54-week treatment period, following a switch from reference infliximab at week 30. 220 patients were randomly assigned to four groups (maintained groups [CT-P13 and reference infliximab] and switched groups [reference infliximab to CT-P13 and CT-P13 to reference infliximab]) in a double-blinded manner. Efficacy, pharmacokinetics (PK) and safety were comparable among all treatment groups up to week 30.2 The Crohn’s Disease Activity Index - 70 (CDAI-70) response, clinical remission and the Short Inflammatory Bowel Disease questionnaire (SIBDQ) score, a measure of quality of life for people with inflammatory bowel disease, were similar among all groups at each measured time point up to week 54 too.1

The safety profiles among all treatment groups, including adverse reactions, serious adverse events, infections, and immunogenicity were similar throughout the one year treatment period.1

Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany, commented on the study, “This is the next randomised controlled trial following the NOR-SWITCH study in patients with inflammatory bowel disease using CT-P13 infliximab that shows positive results. All treatment groups in this study, including reference infliximab maintenance, CT-P13 infliximab maintenance, and switching in both directions (reference to CT-P13 and CT-P13 to reference) groups showed comparable efficacy and safety. As a gastroenterologist, I find these data reassuring and hope they help my fellow physicians make informed treatment decisions to ensure the best outcomes for their patients.”

Improving patient treatment experience of CT-P13

Celltrion Healthcare also presented data from an initial phase I open label study of a subcutaneous (SC) form of CT-P13 in healthy volunteers. The study was designed to evaluate the safety and PK of CT-P13 SC. Results showed PK profiles after a single SC injection were linear by dose levels. Subcutaneous administration of CT-P13 was found to be feasible in terms of bioavailability and safety profile and could provide patients with a more convenient and accessible treatment administration option.3

Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “Active switching to biosimilars could have a significant impact on the financial sustainability of healthcare systems by generating budget savings for biologic treatments. This switching study in Crohn’s disease is important in showing clinical evidence of the comparable safety and efficacy when switching to biosimilars. Adding to the wealth of data for CT-P13, Celltrion Healthcare is confident that these results should help physicians to feel even more confident in switching between reference products and biosimilars and is committed to continuously providing more convenient treatment options, including the subcutaneous form of infliximab to patients.”

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.4 They affect an estimated 2.5-3 million people in Europe;5 CD affects about three people per 1,000 and UC about 5 people per 1,000.4

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.5

About Celltrion Healthcare

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/.

About CT-P13 3.4 CD RCT

The study is a randomised, double-blind, parallel-group, phase III study to investigate the efficacy and safety of CT-P13 compared to reference infliximab in people with Crohn’s disease. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis and 180 patients completed up to week 30. At week 30 approximately half of the patients in each group were switched to the alternative treatment up to 54 weeks. 166 patients completed the study to 54 weeks. The study was funded equally by Celltrion and Pfizer.

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 Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra™. CT-P13 is approved in more than 80 countries (as of October 2017) including the US, Canada, Japan and throughout Europe.

1 Kim YH, et al. LB04, Phase III randomized controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn’s disease: 1-year maintenance and switching results. Presented at the 25th United European Gastroenterology Week Congress.
2 Kim YH, et al. Phase III randomized double-blinded, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab (INX) in patients with active Crohn’s disease: early efficacy and safety results. Gastroenterology 152, S65 (2017).
3 R. Westhovens et al . P0387, Subcutaneous administration of a novel formulation of CT-P13 (Infliximab biosimilar) is safe and achieves projected therapeutic drug levels: a phase Ⅰ study in healthy subjects, Presented at the 25th United European Gastroenterology Week Congress.
4 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. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017].
5 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.

Contact information

For Celltrion Healthcare:
Emma Gorton, +44 203 817 6591
egorton@hanovercomms.com
or
Suru Douglas, +44 203 817 6586
sdouglas@hanovercomms.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma17.1.2018 01:05Tiedote

Regulatory News: Ipsen (Euronext:IPN; ADR:IPSEY) and Exelixis, Inc. (NASDAQ:EXEL) today announced detailed results of the pivotal phase 3 CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC), which will be presented in a late-breaking oral session at the 2018 ASCO-GI Symposium being held in San Francisco, January 18-20, 2018. In CELESTIAL, cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival (OS), the trial’s primary endpoint, at the planned second interim analysis (prespecified critical p value ≤ 0.021) for the population of second- and third-line patients enrolled in this study. Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Median progression-free survival (PFS) was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001). Objective resp

IFF to Release Fourth Quarter & Full Year 2017 Results February 1417.1.2018 00:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, announced that it will release its fourth quarter and full year 2017 earnings results following the market close on Wednesday, February 14, 2018. The management team will host a live webcast on Thursday, February 15, 2018 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) is a leading innovator of sensorial experiences that move the world. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration drives us to co-create unique products that consumer

President Clinton to Address Healthcare Leaders Focused on Eliminating Preventable Deaths in Hospitals at the 6th Annual World Patient Safety, Science & Technology Summit16.1.2018 22:17Tiedote

For the 6th year in a row, President Bill Clinton, the Founder of the Clinton Foundation and 42nd President of the United States, will deliver keynote remarks at the 6th Annual World Patient Safety, Science and Technology Summit held in London, England, February 23-25, 2018. President Clinton, who serves as Honorary Chair of the Patient Safety Movement Foundation’s Regional Network Chairs, joins an acclaimed group of global leaders, government representatives, healthcare and hospital CEOs, medical experts and patient advocates who will gather for the first time in London to confront preventable hospital deaths around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180116006614/en/ President Bill Clinton, the Founder of the Clinton Foundation and 42nd President of the United States, to speak at the 6th Annual World Patient Safety, Science & Technology Summit in London, England (Photo: Business Wire) “We are thrilled

Disaronno: The Mixing Star Makes a Step Change and Looks to Innovation16.1.2018 19:06Tiedote

After 10 years of competitions involving bartenders from different countries who were challenged to showcase the mixability of Disaronno, Disaronno’s contest The Mixing Star has changed direction. Convinced that trends today move on channels other than a performance in front of a jury, Disaronno, the most consumed Italian liqueur in the world and the brand embodying the coolest soul of Made in Italy, has transformed The Mixing Star to Innovation Hunter, a social media based "exploration" with a mission: identifying innovative trends in mixology and movers and shakers in the field, in the UK and around the world, filming and sharing them with the community of bartending experts. In London, Milan and Amsterdam Disaronno has selected a few bartenders who are revolutionizing the field. The ways in which they express innovation have been collected in a set of stylish short movies specially made by Disaronno. The protagonists are available on The Mixing Star Facebook page and YouTube channel

Christie’s Announces Public Preview Tour Dates for The Collection of Peggy and David Rockefeller16.1.2018 18:54Tiedote

Christie’s is pleased to confirm additional dates and locations for public preview exhibitions of the Collection of Peggy and David Rockefeller. Following the unveiling of early highlights in Hong Kong last November, Christie’s will now tour property to its flagship galleries in London (February 21 – March 8), Beijing (April 6 - 7), Los Angeles (April 6 – 12), and Shanghai (April 10 - 11), leading up to the auctions at Christie’s Rockefeller Center in New York in late spring. With each stop on the pre-sale tour, additional works of art and objects will be unveiled, revealing new facets of this storied, multi-category collection. The exhibitions, which are open to the public, are sponsored in partnership with private aviation company VistaJet. As a guide for collectors, Christie’s has launched a special issue of Christie’s Magazine dedicated to the Collection of Peggy and David Rockefeller. The issue re-acquaints readers with the Rockefeller family’s unique place in American history, an

Continuum Accelerates Global Expansion with Portland Europe16.1.2018 18:00Tiedote

Continuum ®, the exclusive provider of the only vertically integrated IT service delivery platform that enables MSPs to scale rapidly and profitably, today announced that it has signed a distribution agreement with Portland Europe, a leading distributor of scalable software solutions for the reseller channel throughout the Benelux region. The partnership will provide Portland Europe’s wide network of managed solution providers (MSPs) in the Benelux region with access to Continuum’s fully-managed remote monitoring and management (RMM) platform, powered by the company’s network operations center (NOC). Continuum’s platform has been proven to enable MSPs to efficiently manage thousands of customer endpoints, giving them back the resources to focus on higher-end, more profitable tasks at a time when skilled IT workers are highly sought-after. As opposed to having to correspond with multiple vendors, Portland Europe customers will benefit from having Continuum serve as a single point of con

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme