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
Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings30.8.2026 14:23:00 CEST | Press release
–Late-Breaking Prespecified Subgroup Analysis of HELIOS-B Demonstrates that Vutrisiran Provided Consistent Clinical Benefit Across All-Cause Mortality and Recurrent Cardiovascular Events in Patients With or Without Tafamidis Use at Baseline ––Additional Post Hoc Analyses Highlight Positive Impact of Vutrisiran in Addressing the Multisystemic Manifestations of ATTR-CM ––Pooled Analysis Across Four Positive Phase 3 Studies of Vutrisiran and Patisiran Shows Consistent Treatment Effect Across Sexes ––New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new data at the European Society of Cardiology (ESC) Congress 2026 demonstrating the strength of RNAi-powered silencing for cardiovascular disease. The findings further reinforce the clinical profile of AMVUTTRA® (vutrisiran) across transthyretin amyloidosis (ATTR)
New Auction Record Set as Falcon Sells for AED 1.5 Million at ADIHEX 202629.8.2026 23:54:00 CEST | Press release
Qarmousha Pure Ultra White falcon sells for AED 1.5 million at the Abu Dhabi International Hunting and Equestrian Exhibition 2026 (ADIHEX) falcon auction Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler’s Representative in Al Dhafra Region and Chairman of the Emirates Falconers’ Club, the fifth auction held as part of the 23rd edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) 2026 attracted remarkable turnout, culminating in the sale of a Qarmousha Pure Ultra White falcon for AED 1.5 million (USD 408,000). The sale marks the highest price achieved at any auction during this year’s edition of the exhibition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260829032621/en/ Qarmousha Pure Ultra White (Photo: AETOSWire) This forms part of the largest auction programme in the exhibition’s history, held under the theme “A Legacy of Pride,” organised by ADNEC Group, a Modon
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro
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