Business Wire

Celltrion Healthcare Presents Phase III Switching Data Supporting the Long-Term Efficacy and Safety of Truxima® (CT-P10, Biosimilar Rituximab) in Rheumatoid Arthritis Patients

Del

New data presented at the 2017 American College of Rheumatology (ACR) Annual Meeting show that CT-P10 is comparable to reference rituximab in terms of efficacy, pharmacodynamics (PD) and safety profile, over a sustained period of time after switching from reference rituximab in patients with rheumatoid arthritis (RA).1

A total of 295 patients participated in the extension period of the phase III, randomised controlled trial after completing treatment up to 48 weeks with CT-P10 or reference rituximab. Patients with RA in both groups during this main period demonstrated equivalent efficacy and similar pharmacokinetic (PK) and safety profiles.2

During the extension period, patients who previously received reference rituximab either maintained treatment or were switched to CT-P10. Efficacy, PD, safety and immunogenicity were evaluated for a further 24-weeks. CT-P10 showed long term effectiveness and tolerability throughout, and the DAS28-CRP improvement, ACR and EULAR response rates, all clinically recognised measurements of efficacy, were comparable between patients switched to CT-P10 and those in the maintained group.1

Professor Alten, Director of the Rheumatology Research Centre at the Teaching Hospital of the Charité, Berlin said: “In the field of rheumatology, whether to switch patients to biosimilars is a pressing question among physicians. Therefore, it is important to see results from studies such as this one, which shows comparable long-term efficacy and safety of CT-P10, a biosimilar for rituximab following switching.”

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “The study shows the comparability of our biosimilar rituximab, CT-P10, to the reference rituximab after switching over a sustained period of time. This adds to the increasing wealth of long-term data in support of CT-P10 in rheumatoid arthritis, demonstrating its continuous effective use, which should help physicians feel confident in switching their patients to this biosimilar rituximab.”

--- Ends---

Notes to editors:

About CT-P10 (biosimilar rituximab)

CT-P10 is a monoclonal antibody that targets CD20, a transmembrane protein found on the surface of most B cells. By binding specifically to CD20, CT-P10 depletes B cells by three main mechanisms: Induction of apoptosis, Stimulation of CDC (complement-dependent cytotoxicity), Stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity).

CT-P10 is approved in the EU for the treatment of patients with Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for CT-P10 are available in the summary of product characteristics (SmPC).3

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.4 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

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/

References

1 Shim et al. Efficacy and safety of rituximab biosimilar, CT-P10, after a single switch from innovator rituximabs in patients with rheumatoid arthritis: Results from phase 3 randomised controlled trial over 72 week. American College of Rheumatology (ACR). 2017. 2445.
2 Suh et al. Randomised double-blind study shows comparable long-term efficacy and safety between rituximab biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: 48 week results. Annual European Congress of Rheumatology (EULAR). 2017. SAT0146
3 Truxima concentrate for solution for infusion summary of product characteristics [last accessed November 2017]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004112/WC500222694.pdf.
4 NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed November 2017].

Contact information

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

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

Tan Delta: New Oil Condition Monitoring Kit for Gas Engine Operators Reduces Daily Operating Costs, Improves Equipment Efficiency and Extends Equipment Life.23.11.2017 13:38Pressemelding

The new Gas Engine oil condition monitoring kit from Tan Delta Systems can be quickly and easily fitted to any gas engine and enables the oil to be monitored and tracked continuously in real time enabling significantly reduced maintenance costs, increased equipment efficiency and extended equipment life. Operators can expect their investment returned in under four months followed by many years of net financial and operational benefits. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171123005177/en/ Gas Engine Oil Condition Monitoring (Photo: Business Wire) The kit includes everything needed for quick and easy installation on any gas engine operating in any environment. No more need for expensive laboratory oil testing. Reduce daily operating costs by optimising maintenance schedules. Protect a

Making Institut Curie a Reference for Technology Transfer in Oncology23.11.2017 13:00Pressemelding

Institut Curie has adopted an ambitious strategy for technology transfer and partnerships with innovative companies. This new dynamic, initiated within the framework of the 2015-2020 MC21 strategic plan (Marie Curie in the 21 st century), aims at positioning the Institut Curie as a reference for technology transfer in oncology. The strategy ambition to better accompany Institut Curie researchers and physicians in the protection, development and commercialization of their inventions, and reinforces support for the setting-up of collaborations with innovative companies. "The objective is to optimize the identification, promotion and transfer of all the scientific, technological and medical resources of the Institute in an open innovative approach" says Amaury Martin, Executive Director of Institut Curie Technology Transfer

Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 5023.11.2017 08:00Pressemelding

WDX ranks No.18 in the 17th annual Sunday Times Hiscox Tech Track 100 league table league which consisted of the top 100 private technology, media and telecoms (TMT) companies in Britain. WDX recorded a 155% average annual sales growth per year over the last 3 years with sales reaching £6.4M in September 2016 and £9m by end of September 2017. More recently, in November 2017, WDX also announces ranking No.19 in the 2017 Deloitte UK Technology Fast 50, a ranking of the 50 fastest growing technology companies in the UK. Rankings are based on percentage revenue growth over the last four years of which, WDX grew 1,563% during this period. WDX attributed this revenue growth to the team’s hard work and the positive change in attitude toward technology in the Wealth and Investment Management industry. WDX’s CEO, Gary Linieres credits the team with the company’s revenue growth. He sa

Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia23.11.2017 07:00Pressemelding

Mobidiag Ltd, a Finnish molecular diagnostics company, today announced a distribution agreement with Interlux OÜ, supplier of technologies for medicine, science and biotechnology industry. Under this agreement, Interlux becomes the exclusive distributor of the Amplidiag® product line in Estonia, in vitro diagnostic tests and compatible instrument for the detection of gastrointestinal infections. “Thanks to a large distribution network, our Amplidiag product line is now accessible in most Western European countries. This new distribution agreement allows us to introduce the Amplidiag product line to the Baltic region starting with Estonia. We are then very happy to start this new partnership with Interlux to support us in this new market”, said Miquel Vernet, CCO at Mobidiag. “Cooperation with Mobidiag offers the customers of Interlux high-quality diagnostic results. I believ

OCP Announces Date of 2017 Third Quarter and Nine Month Results22.11.2017 16:59Pressemelding

OCP S.A., a global leader in the fertilizer industry, will release its third quarter and nine month 2017 results on Thursday, November 30, 2017. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal at 9 a.m. EDT and 2 p.m. Morocco/London time. OCP senior management will host a conference call to discuss 2017 third quarter/nine month results at 10 a.m. EDT and 3 p.m. Morocco/London time on Thursday, November 30, 2017 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fert

Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets22.11.2017 14:46Pressemelding

As part of the company’s transformation journey undertaken in 2016, Tata Motors commenced a comprehensive project to articulate its corporate branding. Basis a thorough analysis of the existing and the desired future state of the Company, Tata Motors has defined its new brand identity as ‘Connecting Aspirations’ across 46 markets, internationally. ‘Connecting Aspirations’, as the new defining maxim, represents the personality of the brand as an interconnected system of mobility solutions, that are intelligent, perceptive, warm and expressive. It’s a symbolic tagline that represents the company’s past, present and future. It is humble yet bold, a statement as well as a challenge. It will define the way Tata Motors communicates with its internal as well as external stakeholders, and work as an all-encompassing guiding principle across business units.” Speaking on the

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom