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
Westlake Expands Global Chlorovinyls Manufacturing Capacity With Acquisition of PVC and VCM Plants in Wilhelmshaven, Germany15.6.2026 20:18:00 CEST | Press release
Westlake Corporation (NYSE: WLK) (“Westlake”) announced today that its German subsidiary, Westlake Vinnolit GmbH & Co. KG, has completed the previously-announced acquisition of a polyvinyl chloride and vinyl chloride monomer production site located in Wilhelmshaven, Germany (the “Wilhelmshaven plant”). The Wilhelmshaven plant, which was previously in insolvency administration, has the capacity to produce 380,000 metric tons of PVC per year. “This acquisition strengthens our Performance & Essential Materials business by expanding our global chlorovinyls manufacturing footprint and complements our existing chlorovinyl production facilities in Europe and North America,” said Jean-Marc Gilson, President and Chief Executive Officer of Westlake. “The Wilhelmshaven plant, which is located in Lower Saxony on Germany’s North Sea coast, benefits from advantageous logistical infrastructure, including a deep-water dock that enables efficient raw-materials supply. We look forward to welcoming the s
Onera Announces Integration of the Onera hPSG® Solution With Somnoware15.6.2026 19:35:00 CEST | Press release
Onera hPSG®, an end-to-end home polysomnography solution from Onera Health, is now integrated into Somnoware, enabling their customers to conduct Polysomnography tests (PSGs) in the patient's home while managing the entire workflow in Somnoware. Onera Health, a leader in transforming sleep medicine, announces that its end-to-end home polysomnography solution, the Onera hPSG® solution, now integrates with Somnoware by ResMed sleep lab management software. This integration enables clinicians to conduct Polysomnography tests (PSGs) where patients sleep most comfortably, in their own home, while managing the entire workflow in Somnoware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615106079/en/ Onera hPSG®, an end-to-end home polysomnography solution from Onera Health, is now integrated into Somnoware, enabling their shared customers to conduct Polysomnography tests (PSGs) in the patient's home while managing the entire wo
Digital Cooperation Organization Launches Global Expert Community to Accelerate International Digital Cooperation15.6.2026 18:18:00 CEST | Press release
A global platform mobilizing expertise and collective action to advance shared digital priorities The Digital Cooperation Organization (DCO), the world's first standalone international organization dedicated to inclusive and sustainable digital economy growth, today announced the launch of the Global Expert Community (GEC) — a new platform designed to mobilize expertise and advance international collaboration in support of high-impact digital initiatives across DCO Member States and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615565781/en/ Digital Cooperation Organization Launches Global Expert Community to Accelerate International Digital Cooperation (Graphic: AETOSWire) The GEC reflects the DCO's continued commitment to turning digital cooperation into action by expanding access to specialized expertise and strengthening collaboration across sectors and borders. As digital transformation reshapes economies an
New Pivotal Study Data Show Takeda’s Oveporexton Improved Daily Function, Cognition and Nighttime Sleep for People with Narcolepsy Type 115.6.2026 18:00:00 CEST | Press release
- Secondary and Exploratory Endpoint Results from Phase 3 Studies Presented at SLEEP 2026 Underscore Improvements with Oveporexton Across a Broad Range of Daytime and Nighttime Symptoms - Takeda is on Track to Bring the First and Only Orexin Agonist to People Living with Narcolepsy Type 1 with Regulatory Submissions Under Review Takeda (TSE:4502/NYSE:TAK)today presented additional results from two pivotal studies at SLEEP 2026, showing oveporexton (TAK-861), an oral orexin receptor 2 (OX2R)-selective agonist, improved daily functioning as well as cognitive and sleep-related symptoms associated with narcolepsy type 1 (NT1).1,2,3 Oveporexton is designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. These data, along with previously disclosed Phase 3 results, demonstrated improvement across the broad disease spectrum, supporting the potential of oveporexton to redefine the standard of care for NT1.4 "Narcolepsy type 1 is a 24-hour disease drive
Boomi Named a Pioneer in June 2026 Gartner® Emerging Market Quadrant for No-Code Agent Builders15.6.2026 17:30:00 CEST | Press release
For Boomi, this recognition reinforces its vision and momentum in enterprise agentic AI Boomi, the data activation company for AI, today announced it has been recognized as aPioneer in the Gartner® Emerging Market Quadrant for No-Code Agent Builders (NCAB). Gartner defines the NCABs market as SaaS-delivered products that offer an integrated design and runtime environment to build, publish and manage AI-powered agents without using coding. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615413216/en/ Boomi Named a Pioneer in June 2026 Gartner® Emerging Market Quadrant for No-Code Agent Builders Boomi sees this recognition as a reflection of the company's rapid evolution from an integration and automation powerhouse to a full-scale agentic infrastructure platform, expanding Boomi’s role in the emerging agentic AI market. A New Chapter in Enterprise Agentic AI According to Gartner, vendors recognized as a Pioneer in this quad
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