Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III
Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and Stelara, the reference drug, in global phase III.
Stelara is a blockbuster drug developed by Janssen Biotech Inc. and indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis; it recorded USD 16.8 billion (IQVIA, MAT Sept 2022) sales worldwide, making it one of the highest grossing biologic medicines.
DMB-3115 global phase III first kicked off in the US back in 2021 and then in eight European countries, including Poland, Estonia, and Latvia, with a total patient number of 605 over 52 weeks. Patients with moderate to severe chronic plaque psoriasis were treated with DMB-3115 or Stelara PFS to compare efficacy, safety, and immunogenicity. The trial was performed as a randomized, double-blinded, multicenter, parallel, and active-control study.
In accordance with the recommendation from the regulatory agencies, primary endpoint time frames were set as Week 8 and Week 12 for the EMA and the FDA, respectively.
DMB-3115 and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12. Similarly, there was no clinically significant difference in safety.
As the results are met for their differing recommendation of EMA and the FDA, the data is expected to be received more positively when submitted for marketing authorization to the respective agencies.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights of Dong-A Socio Holdings for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management; since then, Dong-A ST and Meiji Seika Pharma worked together for the development of the drug.
In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas, a leading multinational pharmaceutical company, and granted the exclusive rights for regulatory approval and commercialization of DMB-3115 in the territories excluding Korea, Japan and some Asian countries. DMB-3115 will be commercialized by Intas through its worldwide affiliates including Accord Biopharma in the US and Accord Healthcare in Europe, the UK and Canada. Dong-A ST and Meiji Seika Pharma are responsible for R&D and supply of the product to Intas and its worldwide affiliates.
Binish Chudgar, Vice-Chairman & Managing Director of Intas Pharmaceuticals, said, "This agreement with Dong-A ST and Meiji Seika Pharma emphasizes our commitment to acquiring advanced research to leverage our leadership position internationally. Further supporting our dedication to drive our mission of making world-class drugs more accessible to patients, globally."
Min-young Kim President & CEO Dong-A ST, said, “We will leverage the successful global phase III of DMB-3115 and submit the marketing authorization application for the US and the EU in the first half of 2023,” and continued, “We are committed to supplying DMB-3115 to the global market at the earliest date possible through close cooperation with Intas Pharmaceuticals.”
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About 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.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
More Than Half of Visitors to teamLab Planets in Toyosu, Tokyo Now Come From Overseas. Starting in March, Artworks Featuring Cherry Blossoms That Bloom Across the Space Will Be on View for the Spring Season Only27.1.2023 18:00:00 CET | Press release
Approximately 100,000 people from overseas visited teamLab Planets in Toyosu, Tokyo, between December 9, 2022 and January 9, 2023. (*1) Of the visitors across one month, around 60% , or 1 in 2 visitors, were non-residents visiting Japan (*1), and the number of visitors from overseas has tripled compared to the same month in 2019 (before COVID-19). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230126005440/en/ teamLab, Floating in the Falling Universe of Flowers © teamLab Furthermore, according to a survey conducted by the museum, about 70% of the visitors from overseas knew about the museum before considering their trip to Japan, and there was a trend of the museum being one of the main purposes to visit Tokyo. (*2) *1 From the official website tickets purchaser data (survey period: December 9, 2022 - January 9, 2023) *2 From the visitor survey data (survey period: December 17, 2022 - January 10, 2023) We will continue to p
Global Processing Services Appoints Former Visa Executive Jim McCarthy to Lead Global Sales and Product27.1.2023 11:01:00 CET | Press release
Global Processing Services (“GPS”), a fast-growing next-gen global payments technology platform, today announced the appointment of Jim McCarthy as Executive Vice President – Global Head of Sales and Product, and Kevin Fox as the company’s new Chief Revenue Officer. In this newly created role, Jim will lead GPS’ global commercial and product teams in close collaboration with Kevin on sales acceleration. Jim is a highly accomplished payments veteran with over 30 years of experience, including 18 years at Visa where he held senior roles in sales, risk and authentication, consumer credit, digital products and product innovation. As Visa’s EVP of Innovation and Strategic Partnerships, Jim was responsible for the development of Visa’s product and technology roadmap, innovation efforts, and led business development for strategic partnerships. While at Visa he was responsible for the introduction of 3D Secure and Visa Token Service, which have become industry standards, and also contributed t
Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.27.1.2023 07:00:00 CET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). In the E.U. there are currently only symptomatic treatments for FOP, which do not reduce the formation of extra-skeletal bone in patients with the condition. Ipsen will be requesting a re-examination of the CHMP opinion, based on scientific data available from the existing palovarotene clinical trial program. FOP causes permanent and continuous new bone formation in soft and connective tissues, like muscles, tendons and ligaments, a process known as heterotopic ossification (HO).1 Once formed, it is irreversible.1 The average age of diagnosis is 5 years old2 and ultimately FOP shortens the median life expectancy to 56 years as untimely death is
Green Steel Technology Company Boston Metal Announces $120M Series C Financing Led by ArcelorMittal27.1.2023 06:01:00 CET | Press release
Boston Metal, a company developing technology to fully decarbonize steel production, today announced the $120 million first close of Series C fundraising led by multinational steel company, ArcelorMittal S.A. (NYSE: MT). Microsoft's Climate Innovation Fund and SiteGround Capital also joined as new investors in this round, alongside current investors. ArcelorMittal’s lead investment was made through its XCarb® Innovation Fund. Commenting, Aditya Mittal, CEO, ArcelorMittal, said, “In Boston Metal, we are investing in a team that has made impressive progress over a relatively short period of time, developing a technology that has exciting potential to revolutionize steelmaking. In our extensive discussions with them, we have been impressed by the passion and vision they have to contribute to the decarbonization of steelmaking. They are an exciting and welcome addition to the XCarb® Innovation Fund’s portfolio.” Boston Metal’s patented Molten Oxide Electrolysis (MOE) process is being comme
Toyota Tsusho, IIJ, NEC, and NTT Com Sign Contract with Uzbektelecom for Telecommunications Infrastructure Development Project27.1.2023 06:00:00 CET | Press release
Toyota Tsusho Corporation ("Toyota Tsusho"), Internet Initiative Japan Inc. ("IIJ"), NEC Corporation ("NEC"), and NTT Communications Corporation ("NTT Com") announced today the conclusion of a contract with Uzbektelecom, a state-owned telecommunications operator in Uzbekistan, for a telecommunications infrastructure development project ("the Project") to provide data center and telecommunications infrastructure for an advanced data communication system ("the System"). Installation of the System is scheduled to begin in 2023 and the sequential launch of operations is expected to significantly improve the communications environment of Uzbekistan. 1. Background In response to the rapidly growing data communication demand driven by the digitalization of various industries, Uzbekistan is expanding its telecommunications infrastructure aimed at issues such as improving communications quality and closing the digital divide between urban and rural areas. In accordance with this background, the