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
comforte Launches TAMUNIO Assure to Modernize HPE Nonstop Cryptography for the Post-Quantum Era2.6.2026 10:10:00 CEST | Press release
New solution helps HPE Nonstop teams modernize SSH & SSL/TLS security using quantum-safe cryptography, centralize key and secrets management, and automate certificate and key lifecycles. comforte AG, a global leader in data-centric security for HPE Nonstop environments, today announced the launch of TAMUNIO Assure, a purpose-built solution for HPE Nonstop that helps organizations modernize cryptographic security without application rewrites or disruption to mission-critical systems. TAMUNIO Assure helps organizations enhance SSH & SSL/TLS security, centralizing keys, credentials, certificates, and secrets, and automating certificate and key lifecycle management across HPE Nonstop systems. The result is stronger security, more cost-effective operations, and a quantum-safe security posture without rewriting critical applications or introducing high-risk platform changes. The crypto operating model for HPE Nonstop is changing HPE Nonstop systems power some of the world’s most demanding tr
NIPPON KINZOKU Launches Sample Supply of “Internally Polished Capillary Tubes” for High-Performance Analytical Instruments2.6.2026 10:01:00 CEST | Press release
- Achieving Internal Surface Roughness of Ra ≤ 0.2μm in Ultra-Small 0.30 mm ID Tubing - NIPPON KINZOKU CO., LTD. (TOKYO: 5491) (Headquarters: Minato-ku, Tokyo) announces the launch of a sample supply system for its "Internally Polished Capillary Tubes." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602111592/en/ Cross-section of the tube after polishing These tubes feature significantly enhanced internal smoothness in ultra-small sizes, realized through the development of the company’s proprietary internal polishing technology. We are currently proceeding with the design and construction of manufacturing equipment, aiming for mass production within fiscal year 2027. Background: Rising Demand for "Ultra-Small Diameter x Ultra-Smooth Internal Surfaces" We have previously developed high-precision, small-diameter tubes made of austenitic stainless steel with an internal diameter (ID) of 0.50mm and internal surface roughness
OPEX® Honored with Warehouse Automation Solution of the Year Award for First-of-its-Kind Cold Storage Solution2.6.2026 10:00:00 CEST | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, has been honored by Logistics Matters magazine with the 2026 Warehouse Solution of the Year Award. OPEX was recognized for the company’s first-of-its-kind, multi-temperature zone, multi-deep cold storage solution for automated warehouse fulfillment systems, enabled through a strategic technology partnership with cold chain commerce innovator Peltier. The collaboration introduced advanced, multi-temperature capabilities to OPEX’s industry-leading Perfect Pick® and Infinity® automated storage and retrieval systems (AS/RS) through the addition of the Peltier Tote™. “We’re deeply honored to receive such distinguished recognition by Logistics Matters magazine,” said Monty McVaugh, Head of Product, Warehouse Automation, OPEX. “By integrating Peltier’s tote technology into the existing framework of Perfect Pick and Infinity, OPEX can deliver a flexible,
Smartstream Launches Smart Agents for Back-Office Operations, Proven Across Tier 1 Pilots2.6.2026 09:55:00 CEST | Press release
Key Facts Smart Agents is now widely available to Smart Reconciliations clients, covering bank reconciliations, cash breaks, settlement exceptions, and post-trade investigations — combining client institutional knowledge with Smartstream’s domain expertise to deliver value from day one. Pilot results demonstrate a 97% reduction in investigation time per exception, from 14 minutes manually to 30 seconds, with Tier 1 clients projecting 50–70% automation in year one. Smart Agents surfaces the steps requiring human action and executes everything else autonomously — including counterparty and internal communications, available in assistive and autonomous operating modes with human-in-the-loop oversight, full audit trail, step-by-step explainability, complete data privacy, and intelligence that compounds continuously over time. Smartstream, a trusted data solutions provider for leading global financial institutions and enterprises, today announced the availability of Smart Agents, its agenti
ThetaRay Gamifies Financial Defense at Money20/20 Europe with a Compliance Twist on “Where’s Waldo”2.6.2026 09:30:00 CEST | Press release
With “Spot The Money Mule”, ThetaRay unites Agentic AI and public education to disrupt criminal recruitment; pushing for an ecosystem-wide stand against illicit finance. ThetaRay, a leader in AI infrastructure for financial crime compliance, today unveiledSpot The Money Mule at Money20/20 Europe. The high-speed online game is a compliance twist on "Where’s Waldo" for the AI age, designed to bridge the gap between complex banking infrastructure and the public’s role in stopping global crime. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602629234/en/ The game challenges players to find a money mule hidden in plain sight across five buzzing everyday scenes, from the morning rush at an airport to the vibrant rows of a Dutch Tulip Festival. “In the AI age, the most dangerous threats are those that blend perfectly into the speed of our digital lives,” said Garima Chaudhary, VP Financial Crime & Compliance AI at ThetaRay. “In
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