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
Thales and Gemalto are granted regulatory clearance by the European Commission11.12.2018 17:01 | Pressemelding
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto announce today that they have been granted merger control Regulatory Clearance by the European Commission, following Thales’s commitment to divest its general purpose hardware security modules (GP HSM) business globally1 to a suitable purchaser. This clearance is effective immediately. Together with the merger control clearances obtained in China, Israel, South Africa and Turkey, and clearances relating to f
Starr Insurance Companies Expands Aviation Insurance Operations to Brazil11.12.2018 15:43 | Pressemelding
Starr Insurance Companies today announced that Starr International Brasil Seguradora S.A. (“Starr Brazil”) has been granted a local license to offer aviation insurance. “We are thrilled to be adding aviation capability in an important, growing economy like Brazil,” stated Steve Blakey, president and chief executive officer for Starr Insurance Holdings, Inc. “As a worldwide leader in aviation insurance solutions, we are constantly seeking new opportunities and markets to meet the growing needs of the aviation and aerospace industry around the globe.” Fernanda Strachino, aviation specialist underwriter, has joined Starr Brazil to head the new aviation division. Fernanda brings more than 16 years’ of experience in the aviation and insurance market. Starr Brazil will offer a variety of aviation coverages, including: Aircraft Hull & Liability; Spare Parts; Third-Party Legal Liability; Corporate Non-Owned Aircraft Liability; General Liability; RETA Insurance (Mandatory Liability), Hangarkeep
Andersen Global Continues Growth in United Kingdom With Claritas Tax Limited11.12.2018 14:30 | Pressemelding
Today, Andersen Global expanded its reach in the United Kingdom with the addition of Claritas Tax Limited, a tax advisory and compliance services firm based in Birmingham, the second largest city in the country. Claritas is the fourth firm collaborating with Andersen Global in the UK. “Adding a sought-after firm like Claritas is not only a logical extension for Andersen Global, but it broadens our offering in the UK. Their practice focuses on corporation tax, R&D tax reliefs, mergers and acquisitions, private equity and venture capital in addition to serving individuals,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “Iain Wright and his team enhance our already robust core competences in the UK, a critical market for our clients, and we look forward to working with Claritas on a number of upcoming corporate opportunities.” Founded in 2012, Claritas Tax Limited is an advisory led business that provides a full range of tax advisory and compliance services to entr
Seoul Semiconductor Wins Patent Litigation against Everlight in Germany and Is Awarded Statutory Litigation Costs11.12.2018 14:00 | Pressemelding
Seoul Semiconductor Co., Ltd. (KOSDAQ:046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it won a patent litigation against Everlight Electronics Co., Ltd. (“Everlight”) in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005233/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) The patent involved in this litigation relates to an LED package structure for thermal dissipation. Everlight purchased this patent from a U.S. company in 2017, and subsequently brought a patent lawsuit against Seoul in the Manheim Court of Germany. In December 2018, however, the Manheim Court ruled in favor of Seoul and ordered that Everlight, as the losing party, should bear the statutory costs of the court proceeding. In the United Kingdom, Seoul had already won a patent litigation against Everlight earlier this year. At that time, the UK Patent Court also ordered that Ever
Zodiac Appoints Derek Harrar CEO11.12.2018 14:00 | Pressemelding
Zodiac, a software vendor serving video service providers, announced today it has appointed Derek Harrar to serve as the Company’s Chief Executive Officer, effective immediately. Mr. Harrar has been on Zodiac’s board of directors since 2015, having being appointed at the time of One Equity Partners’ investment in the Company. “Derek’s considerable video industry operational and technology experience, rigorous execution and creativity are exactly what Zodiac needs for its next stage of growth, complementing the team we have put in place since our original investment,” said Andrew Dunn, Managing Director at One Equity Partners. Zodiac’s historic focus has been engineering software solutions for major video service providers in North America. This software experience, spanning a broad range of video technology permutations, is unique in the video distribution industry. More recently, Zodiac productized its carrier-grade cloud and client platform, enabling rapid and flexible deployment at
The O-RAN Alliance Announces New Board Members11.12.2018 14:00 | Pressemelding
The O-RAN Alliance announced today that Reliance Jio, TIM, and Verizon have joined the O-RAN board. “It’s encouraging to see the O-RAN Alliance off to such a strong start and gaining momentum as we welcome three new board members. It’s important that the wireless industry continues to come together to drive forward O-RAN’s goals for open networking, software, and virtualization in global wireless networks especially as 5G is closer than ever,” said Andre Fuetsch, Chairman of the O-RAN Alliance, President-AT&T Labs and CTO of AT&T. “This is a great opportunity for the Service Provider Industry as network, services and applications leverage cloud native platforms and the right time to fundamentally transform the RAN infrastructure and platforms. We look forward to working closely with the O-RAN Alliance in the acceleration and adoption of open, intelligent, and programmable RAN architectures that can clearly disrupt the building blocks of 5G and beyond,” said Mathew Oommen, President, Re