Significant results confirmed in phase 3 of donepezil patch
World’s first speed to market
Icure(70,900 -9.57%)Is the celltrion(327,000 -1.80%)On the 16th, it was announced on the 16th that the global clinical trial of the donepezil patch for the treatment of Alzheimer’s dementia, which was conducted in collaboration with the company, was successful. It is planning to speed up the commercialization of the world’s first Donepezil patch system by applying for a domestic item license within the first quarter.
According to Icure, through a phase 3 clinical trial’ADAS-Cog’ (a scale that measures the degree of dementia through the evaluation of patients’ cognitive function), the non-inferiority of the patch formulation compared to the existing oral dose of donepezil was verified, confirming the effectiveness and safety. did.
Since 2017, the clinical trial has been conducted on 400 patients with mild and moderate Alzheimer’s in Korea, Taiwan, Australia and Malaysia. Donepezil is the most commonly prescribed ingredient among dementia treatments. Currently, only oral dosage forms are available.
Icure’s Donepezil patch increased the convenience of taking medication by replacing the existing oral drug once a day with a patch twice a week. In addition, it is expected to provide convenience to both dementia patients and carers by reducing drug side effects.
Icure is planning to commercialize it with Celltrion within this year. Within two years, it set a goal to convert 50% of the domestic donepezil oral drug market worth 250 billion won into patch products.
In addition, in the first half of the year, it plans to apply for a phase 1 clinical trial to the US Food and Drug Administration (FDA). It has been informed that a clinical application is possible through a pre-IND meeting with the FDA. Recently, it also obtained a US patent for the Donepezil dementia patch. It is explained that the size of the oral drug market for donepezil in the US is about 2.5 trillion won per year. The company said that only Icure and Corium in the US are developing the Donepezil patch system.
A company official said, “In the case of the United States, you can apply for product approval immediately after completing phase 1 through the ‘505(b)2’ track.” It is expected to be,” he said. He added, “Recently, we have signed a cGMP consulting contract with Estima, a specialized consulting company for cGMP and EUGMP, and are preparing to enter the US market in stages.”
Reporter Minsoo Han [email protected]
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