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
NetApp Delivers Secure, Zero-Copy Data Activation for the Agentic Enterprise29.9.2026 19:30:00 CEST | Press release
Enterprises will be empowered to accelerate AI innovation to machine speed NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced new capabilities that enable enterprises to accelerate their adoption of agentic AI with secure, in-place, zero-copy data activation. The heterogeneous metadata capability of NetApp AI Data Engine (AIDE) helps organizations discover, understand, govern, and operationalize data where it lives, while an expanded integration with Commvault connects the NetApp Platform with Commvault recovery orchestration workflow to help customers detect attacks earlier and recover cleaner data faster. As AI agents move from experimentation into production, enterprise data infrastructure has become a critical business dependency. Agents can read, retrieve, and act on data at machine speed, but most enterprise data estates were built for human-paced workflows: fragmented across file, object, cloud, on-premises, and sovereign environments; governed
NetApp to Expand Partnership with SAP to Support SAP Cloud Infrastructure29.9.2026 19:30:00 CEST | Press release
NetApp to explore integrating NetApp capabilities with SAP Cloud Infrastructure storage architecture, to support secure, resilient, high-performance infrastructure for SAP and customer workloads NetApp, the intelligent Data Infrastructure company, today announced its intent to expand its long-standing partnership with SAP, with plans to explore deeper cloud-native integration of NetApp capabilities into SAP Cloud Infrastructure, SAP’s Infrastructure-as-a-Service platform. The NetApp Platform supports key elements of the SAP Cloud Infrastructure storage architecture, delivering reliable, highly available and high-performance file and block storage services. The NetApp Platform also provides built-in proactive data protection capabilities and data replication to support SAP’s global availability model. “SAP and NetApp share a long-standing commitment to empower the world’s most mission-critical enterprise environments,” said Álvaro Celis, Senior Vice President, Chief Commercial, Partner
NetApp Removes Storage Bottleneck for AI Factories29.9.2026 19:30:00 CEST | Press release
New architecture delivers fastest storage on the planet, designed to maximize GPU utilization and architected for up to 100 TB per second aggregate throughput NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced NetApp Novus™, the fastest storage on the planet designed for AI infrastructure providers operating large GPU environments. Built to support a zettabyte-scale file system, this next-generation architecture will allow AI factories to keep millions of GPUs continuously fed with data, maximizing the efficiency, utilization, and profitability of their investments. Neoclouds and GPU-as-a-Service providers are building AI factories at a scale that traditional storage architectures were never designed to support, creating bottlenecks that reduce GPU utilization and increase infrastructure costs. Under traditional architectures, GPU utilization can drop below 30 percent when AI factories cannot feed enough data to their GPUs to generate the results they
NetApp Empowers Enterprises to Build Anything, Anywhere29.9.2026 19:30:00 CEST | Press release
New hybrid multi-cloud capabilities remove borders between on-premises and cloud operations NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced new hybrid multi-cloud capabilities with autonomous controls to maximize enterprise flexibility and efficiency for any workload. Enterprises can now more easily adopt modern data strategies across on-premises and cloud environments leveraging new capabilities for consistent operations that account for sovereignty, governance, and controlled consumption. As enterprise applications and AI workloads increasingly span on-premises environments, public clouds, sovereign regions, and emerging AI Factory architectures, organizations need more than infrastructure flexibility. They need a consistent operating model that can keep pace with machine-speed demand while meeting requirements for governance, resilience, efficiency, and jurisdictional control. Traditional manual administration, fragmented tooling, and disconnecte
NetApp Enhances Data Sovereignty Controls to Keystone29.9.2026 19:30:00 CEST | Press release
Storage-as-a-Service will enable qualified European customers to use data sovereignty controls in support of their compliance and data residency journeys NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced NetApp Keystone Sovereign, which will enable qualified European customers to use data sovereignty controls in support of their compliance and data residency journeys. Enterprises will more easily be able to keep data and support within specified geographic boundaries. As organizations modernize IT and adopt cloud-like operating models, customers in regulated industries face increasing pressure to keep sensitive data, support, and operations within defined geographic boundaries. For many European customers, sovereignty requirements now extend beyond data residency to include operational access, telemetry, and data flow transparency. With NetApp Keystone Sovereign, qualified European customers can now better address these requirements. “Data sovereignty
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