MA-ICURE-PHARMACEUTICAL
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
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67th American Society of Hematology (ASH) Annual Meeting6.12.2025 15:30:00 CET | Press release
Results from Phase 2a IMPRSSION study demonstrate sapablursen significantly reduced phlebotomy rate, controlled hematocrit and increased serum hepcidin Sapablursen was generally safe and well tolerated Results support further development of sapablursen in a Phase 3 study Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which On
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 15:30:00 CET | Press release
52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety SignalsThese Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary EndpointsPatients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those Initially Randomized to Rusfertide, with 77.9% Achieving Absence of Phlebotomy Eligibility Between Weeks 40-52Four-Year Results from the Combined REVIVE and Long-Term Extension THRIVE Study Demonstrated a 13-Fold Reduction in Annual Rate of Phlebotomies from Baseline Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society
Vertex Presents New Data on CASGEVY®, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 13:01:00 CET | Press release
- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients -- Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older -- Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and
Leading Global Scientists Gather at Tengchong Scientists Forum to Explore Innovative Pathways in Frontier Technologies6.12.2025 12:31:00 CET | Press release
The 2025 Tengchong Scientists Forum opened on Saturday in southwest China’s Yunnan Province, convening leading scientists and academic figures to examine innovation across frontier fields including artificial intelligence, biodiversity and quantum technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205499197/en/ Opening ceremony of Tengchong Scientists Forum on 6th December, 2025 Notable participants include Nobel Physics laureate Konstantin Novoselov, Fields Medalist Efim Zelmanov and Turing Award winner Andrew Chi-Chih Yao, who join 127 academicians, 77 university presidents from China and abroad, over 400 scholars and more than 600 entrepreneurs and financiers. The gathering aims to deepen collaboration between cutting-edge research and industrial development. Under the theme “Science · AI changing the World,” the forum features ten sub-forums, academic sessions and thematic events supporting major cooperation p
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 00:49:00 CET | Press release
‒ Named Most Respected Public Semiconductor Company Achieving $100 Million to $500 Million in Annual Sales ‒ Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive
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