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
CSG Recognized in Multi-Category Trusted Analyst Reports for CPQ, Monetization, and Digital Partner Management27.1.2026 17:05:00 CET | Press release
The depth, innovation, and real-world impact of the company’s telecom portfolio are what make CSG stand out in the industry Communication service providers (CSPs) are under pressure to simplify complexity, monetize new services, and deliver experiences customers trust with speed and accuracy. To succeed, they need partners who can turn quote-to-cash and digital monetization into a competitive advantage, not just a back-office function. Over the past year, CSG® (NASDAQ: CSGS) has achieved multi-category recognition from leading analyst firms for doing exactly that. To CSG, these recognitions reinforce a role as a go-to partner for CSPs looking to move faster, unlock new revenue streams, and modernize their core with AI-powered, telco-specific platforms built for real-world complexity. CPQ Leadership for Complex B2B and B2B2X Monetization CSG Quote & Order continues to stand out for CSPs that need to configure complex offers, quote with confidence, and move from deal to revenue without f
ThetaRay Unveils Ray: An Agentic AI Investigation Suite Delivering Faster, More Consistent AML Investigations27.1.2026 17:00:00 CET | Press release
One of the first agentic suites that accelerates AML case handling, standardizes investigations across jurisdictions, and generates regulator-ready documentation while keeping analysts in full control In the face of rapidly evolving global regulatory standards and rising Anti-Money Laundering (AML) scrutiny, ThetaRay today announced the launch of Ray, an Agentic AI AML investigation suite designed to transform how financial institutions conduct transaction monitoring investigations. Embedded in the ThetaRay Investigation Center, Ray extends Cognitive AI from detection to investigation, combining autonomous investigative execution with on-demand analyst support enabling financial institutions to significantly improve case resolution time and bring greater consistency to the investigation process across teams and jurisdictions. Global regulators are converging on higher expectations for investigative quality and documentation. In the European Union, the new Anti-Money Laundering Regulati
State Street, in Collaboration with ADIO, to Create 300+ New Jobs With Launch of New Al Ain Operations Hub27.1.2026 16:15:00 CET | Press release
The expansion further solidifies State Street’s role as a trusted strategic partner in Abu Dhabi’s financial ecosystem, supporting the emirate’s commitment to regional economic diversification and developing next-generation talent in Al Ain. State Street Corporation (NYSE: STT), one of the world’s leading providers of financial services to institutional investors, has signed a support agreement with the Abu Dhabi Investment Office (ADIO) to establish a new operating center in the Al Ain region, Abu Dhabi. The collaboration marks a significant step in State Street’s long-term expansion strategy in the Middle East and UAE and reinforces its role as a strategic partner within the Abu Dhabi Global Market (ADGM) ecosystem. As part of its long-term growth plan in Abu Dhabi and aligning to State Street’s global clients’ increasing presence in Abu Dhabi, the new operating hub will create more than 300 financial services roles over the next four years, providing meaningful career pathways for l
Arc'teryx Appoints Avery Baker Chief Brand Officer27.1.2026 15:00:00 CET | Press release
Technical apparel and equipment brand appoints first-ever Chief Brand Officer and names Tobia Prevedello General Manager, EMEA Arc'teryx Equipment, the global design company specializing in technical high-performance apparel and equipment, today announced the appointment of Avery Baker as its first-ever Chief Brand Officer, a newly created executive role that marks a significant step in the company’s global evolution. Baker joins Arc’teryx as it continues to unlock brand potential, elevate global capabilities, and fuel long-term growth across North America, EMEA, APAC, and Greater China. Additionally, Tobia Prevedello was appointed General Manager, EMEA, bringing more than 20 years of international leadership experience across EMEA and APAC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127462809/en/ Avery Baker, Chief Brand Officer As Chief Brand Officer, Baker will report to CEO Stuart Haselden and will lead global bra
Research From Lenovo Reveals AI Is Paying Off, Yet Most CIOs Aren’t Ready for What Comes Next27.1.2026 15:00:00 CET | Press release
CIOs anticipate up to 179% ROI on AI investments, with further efficiencies expected as Agentic AI scalesMore than half of organizations (60%) are in late-stage AI adoption – though only 27% have a comprehensive governance framework in placeOnly 21% of CIOs use Agentic AI today, with half (55%) exploring or piloting use casesHybrid AI emerges as preferred deployment model, used by almost two thirds (62%) Enterprises have moved decisively from AI pilots to scaled implementations, driven by proven benefits and expectations of significant financial returns, according to Lenovo CIO Playbook 2026 with research insights by IDC. Nearly half (46%) of AI proof-of-concepts have already progressed into production, with some organizations projecting returns of $2.79 for every dollar invested. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127255538/en/ Lenovo CIO Playbook 2026: The Race for Enterprise AI AI is now recognized as a cor
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