MA-ICURE-PHARMACEUTICAL
16.11.2021 15:03:14 CET | Business Wire | Press release
Icure Pharmaceutical Inc. (KOSDAQ: 175250), a biopharmaceutical company in Korea, announced today that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.
The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.
Donepezil is a current typical treatment that has been widely prescribed for the longest period for Alzheimer’s disease patients in severity ranging from mild to moderate and severe ones among FDA-approved Alzheimer's treatments. Due to difficulty in the development of its formulations, donepezil has been commercialized for only oral administration to date.
With successful completion of a Phase III clinical trial for the first time in the world, the donepezil patch of Icure is expected to significantly improve the quality of life of patients with Alzheimer’s-type dementia and their caregivers by enhancing the convenience in its use from orally taking once daily to putting a patch on skin twice a week.
With nearly 400 mild and moderate dementia patients in Korea, Taiwan, Australia and Malaysia, Icure successfully conducted a Phase III clinical study for its donepezil patch. Specifically, the study demonstrated noninferiority compared to oral donepezil in Alzheimer's disease assessment scale cognitive subscale (ADAS-cog), a typical standard tool for evaluating abilities of memory, language, reorganization, action and orientation in patients with mild and moderate Alzheimer’s-type dementia.
“Based on outstanding efficacy and marketability of donepezil along with our technological prowess, we expect our donepezil patch will sufficiently take over the market of donepezil oral products as we have seen a high conversion rate of rivastigmine patches in the past,” said CEO YoungKweon Choi, Ph.D. of Icure, who led donepezil patch development. “We reported results of the Phase III clinical trial of donepezil patch at the Conference on Clinical Trials of Alzheimer’s Disease (CTAD) that was held on November 9~12, 2021 in Boston, Massachusetts.” He attended the CTAD Conference to present the results of the clinical study while making consultations on potential global transactions.
Now that its donepezil patch received FDA approval for Phase I clinical trial as an investigational new drug in April 2021, Icure will start to administer it to patients in the latter part of 2022. The company expects to begin in 2025 to provide the donepezil patch in the global market by reducing the period of clinical trials through the 505(b)2 clinical study track. Today, the global dementia treatments market is estimated to reach around USD 3 billion, and it is anticipated to increase to roughly USD 5 billion by 2024 as the world transforms into an aging society. Icure plans to expand the global business of transdermal drug delivery system (TDDS) as its production facilities in Wanju, Korea obtained the cGMP certification.
Starting with the donepezil patch, Icure diversifies pipelines by developing a variety of DDS-based incrementally modified drugs and new drugs. Following the donepezil patch, the company is developing a pramipexole patch that will be used for treating Parkinson’s disease. And Icure BNP, a subsidiary of Icure, is currently developing oral liraglutide peptide formulation from injectable liraglutide peptide product that is being used for treating diabetes and obesity while accelerating the development of microneedles and lipid-based nanoparticle (LNP) drugs through CuRsuS Bio and EBA BIO. In addition, Icure is also in the development of the world’s first oral peptide-based anticancer drug and a new drug based on PROTAC through oneCureGen and Dandi Cure, attracting attention on the potentiality of growing into a global pharmaceutical company by developing varied DDS-based new drugs.
For more information on Icure Pharmaceutical Inc., visit https://icure.co.kr .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211116005684/en/
Link:
About Business Wire
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
Freemarket and Axiym launch LIQUI-DT™ – real-time business access to primary-market USD₮ from Tether29.9.2026 08:00:00 CEST | Press release
Freemarket and Axiym today launched a world-first service that gives businesses 24/7 real-time access to freshly minted, primary-market USD₮ issued by Tether. LIQUI-DTTM gives businesses compliant access to primary market stablecoins inside a fully regulated payment ecosystem via Freemarket’s global payment network. In audited trials, clients have minted or burned more than $300 million to date. Institutional users and high-volume traders will benefit from superior price certainty and direct liquidity giving them budgetary control. As the USD₮ is minted directly in the primary market, treasury and compliance teams have clear provenance for internal reporting 1. The LIQUI-DT service works because while no single party owns the whole stack, it is integrated into the Freemarket network. The combination of Freemarket’s compliant fiat rails and payment network, Axiym’s liquidity engine and on-chain settlement layer and Tether’s primary market issuance creates a regulated payments network wi
Estonia and Owkin Partner to Advance Sovereign AI in Biology29.9.2026 08:00:00 CEST | Press release
Estonia, led by the National Applied Research Center Metrosert, and Owkin today announced a collaboration to advance sovereign AI in biological and health research, working with Metrosert, Estonia’s state-owned applied research organisation. The collaboration will evaluate how K Pro, Owkin’s AI scientist platform, can help approved researchers work with complex Estonian health data inside secure national infrastructure, enabling reproducible analysis, and faster generation of scientific insight while preserving data sovereignty. The first phase will focus on selected Estonian health-data cohorts, with Owkin and Metrosert also exploring high-value research areas including oncology, where linked clinical, molecular, imaging and treatment-outcome data could support future biomedical research. Estonia has built one of the world’s most advanced digital public infrastructures and holds population-scale health and biomedical data assets. The partnership will explore how these foundations can
Jumio Completes Worldwide Rollout of selfie.DONE™, Bringing Privacy-Focused Reusable Identity to EMEA29.9.2026 07:00:00 CEST | Press release
Selfie-first onboarding eliminates unnecessary ID scans for trusted users, backed by the global Jumio Identity Graph, consent-based privacy and real-time compliance Jumio, the leading provider of AI-powered identity intelligence, today announced the expansion of its reusable identity solution, selfie.DONE, across Europe, the Middle East, and Africa. This launch marks the final phase of Jumio’s selfie.DONE rollout, following successful launches in Latin America, North America, and Asia-Pacific — making true reusable identity available worldwide wherever Jumio operates. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928989719/en/ In regulated EMEA markets, organizations face the dual challenge of eliminating onboarding friction while adhering to stringent privacy standards and regulatory frameworks, including GDPR, PSD2, AMLD, and other evolving regulatory compliance requirements. selfie.DONE addresses this challenge with a
Copeland to Showcase Solutions for Data Centers, Heat Pumps and Sustainable Refrigeration at Chillventa29.9.2026 07:00:00 CEST | Press release
Technologies designed to help customers improve efficiency, reduce emissions and address evolving cooling, heating and cold chain needs Copeland, a global leader in compression technologies and controls solutions, today announced its participation at Chillventa 2026, taking place Oct. 13-15 in Nuremberg, Germany. From growing data center cooling demands to increased adoption of heat pumps and natural refrigerants, customers across Europe are navigating rapid change. Copeland will showcase technologies designed to address the region's evolving heating, cooling and refrigeration requirements. As demand for energy-efficient cooling, electrified heating and sustainable industrial operations grows across Europe, Copeland continues to invest in the technologies, capabilities and partnerships needed to help customers navigate changing regulatory requirements and work toward their sustainability objectives. Copeland has made a series of strategic investments to support Europe's long-term energ
Lumo Art & Tech Festival Announces Full Programme, Featuring Björk29.9.2026 07:00:00 CEST | Press release
13–22 November 2026 Lumo Art & Tech festival, a new ten-day international festival exploring the intersection of art, technology and science, has announced its full programme for its inaugural edition in Oulu, Northern Finland, as part of the Oulu2026 European Capital of Culture year. Taking place across 16 cultural venues and outdoor locations, the festival brings together exhibitions, light and sound art, audiovisual performances, talks and professional events. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928733910/en/ Björk. Credit: Vidar Logi A key highlight is an exhibition by Icelandic artist and musician Björk, opening on 13 November. Following its debut in Reykjavík, the exhibition brings three audiovisual installations to Oulu’s Pekuri Shopping Centre: Ancestress, Sorrowful Soil and Björk Orkestral. Björk will also perform a special DJ set at the new waterfront venue Tarkastamo on 15 November. The festival’s wi
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