EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar
Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).
The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods. The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326). The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. As a result, the therapeutic equivalence between DMB-3115 and the reference product was verified, and no safety issues were observed.
DMB-3115 is a proposed biosimilar to Stelara®, a blockbuster drug developed by Janssen Biotech Inc., and for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights 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 to develop the drug.
In July 2021, the worldwide distribution rights, excluding Japan, South Korea, and certain Asian regions, were licensed to Intas Pharmaceuticals, a multinational pharmaceutical company. Intas Pharmaceuticals will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.
“We are delighted to reinforce our partnership with Dong-a & Meiji for Accord Healthcare to file for global rights to this critical drug, reinforcing our commitment to improving access to high-quality biosimilar drugs for patients globally,” said Mr. Paul Tredwell, Executive Vice President of Accord Healthcare.
“We will spare no effort to ensure DMB-3115 is supplied to the global market by leveraging a strong partnership between Dong-A, Meiji, Intas, and Accord,” said Mr. Jaehong Park, President & CSO (Chief Science Officer) of DongA ST.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress29.9.2023 20:43:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin. “We are pleased to add to the data supporting the use of ruxolitinib cream for patients living with vitiligo and atopic dermatitis (AD) through two late-breaking presentations – one on prolonged use of treatment in vitiligo patients with limited or no initial response, and the full results of our TRuE-AD3 trial in pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community." Key abstracts from Incyte-sponsored programs include: Late-breaking Oral Presentations Vitiligo Efficacy an
Q4 Inc. Recognized as one of Canada’s Top Growing Companies by The Globe and Mail29.9.2023 17:30:00 EEST | Press release
Q4 Inc. (TSX: QFOR) (“Q4” or “the Company”), the leading capital markets access platform, is pleased to announce their ranking on the 2023 Report on Business of Canada’s Top Growing Companies. Canada’s Top Growing Companies ranks Canadian companies on three-year revenue growth. Q4 earned its spot with three-year growth of 150%. “We are honored to be recognized as one of Canada’s Top Growing Companies for the fourth consecutive year by The Globe and Mail,” remarked Darrell Heaps, Founder and CEO of Q4. “We are proud of the growth we have achieved as a company and this recognition is a true reflection of our dedication to helping our clients win in the capital markets through innovative technology on the Q4 Platform.” Canada’s Top Growing Companies is an editorial ranking that was launched in 2019. It aims to bring the accomplishments of innovative businesses in Canada to the forefront. In order to qualify for this voluntary program; companies had to complete an in-depth application proc
GEDi Cube and Renovaro Biosciences Sign Definitive Agreement to Combine29.9.2023 16:15:00 EEST | Press release
GEDi Cube Intl Ltd. (GEDi Cube), an AI medical technology company, and Renovaro Biosciences Inc. (NASDAQ:RENB) (Renovaro), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy, have signed a definitive agreement to combine, in which GEDi Cube will become a wholly-owned subsidiary of Renovaro in a stock-for-stock acquisition (the “Transaction”). If completed, the Transaction will result in a combined company that will offer advanced early diagnosis and early identification of recurring cancer as well as potential therapies for several critical diseases such as pancreatic cancer and other solid tumors with poor life expectancy. The combined company will have a unique advantage: Renovaro Biosciences’ pre-clinical and clinical trial data could be utilized to accelerate GEDi Cube’s AI capabilities that, in turn, could potentially help to accelerate Renovaro’s development of potential new therapies. AI will be used to advance the fields of diagnosis and treatment with
Offshore Windfarm Hollandse Kust Zuid Inaugurated29.9.2023 14:53:00 EEST | Press release
Today, Dutch King Willem-Alexander jointly with the board members of Vattenfall, BASF, and Allianz officially inaugurated the offshore wind farm Hollandse Kust Zuid 1-4. The wind farm is in the North Sea, 18-36 kilometers off the Dutch coast between the towns of Scheveningen and Zandvoort. The 139 turbines have a total capacity of 1.5 GW, making it one of the largest offshore wind farms in the world. The annual electricity production is expected to equal the consumption of 1.5 million households. Hollandse Kust Zuid is owned by Vattenfall, BASF, and Allianz. The wind farm is expected to be fully operational in 2024 and will be serviced out of the port of IJmuiden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230929518869/en/ Inauguration Hollandse Kust Zuid wind farm. From left to right: Helene Biström (Senior Vice President, Head of Business Area Wind Vattenfall), Martijn Hagens (CEO Vattenfall Netherlands), His Majesty K
The Estée Lauder Companies Launches 2023 Breast Cancer Campaign: Beautifully United to Help End Breast Cancer29.9.2023 14:00:00 EEST | Press release
For more than 30 years, The Estée Lauder Companies’ Breast Cancer Campaign (The Campaign) has been dedicated to advancing the possibility of a breast cancer-free world for all. This October, The Estée Lauder Companies (ELC) honors Breast Cancer Awareness Month by launching The Campaign in support of the global breast cancer community. As ELC’s largest corporate social impact program, The Campaign continues to inspire purpose-driven action and is a cornerstone of the company’s social investments in women’s advancement, health and education. Through The Campaign, ELC has also been a longstanding supporter of women in science, research and medicine – funding numerous grants and programs around the world and accelerating opportunities for women in STEM. The Campaign was founded by Evelyn H. Lauder in 1992 with the launch of the iconic Pink Ribbon. At a time when breast cancer wasn’t spoken about openly, Evelyn and ELC saw an opportunity to bring awareness to the disease and address stigmas
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom