Celltrion-Icure applied for permission for Donepezil patch

The world's first Donepezil patch, applied for permission from the MFDS

Joint contract with Celltrion in 2017 after Icure development

Celltrion announced on the 13th that it has applied to the MFDS for an item license for the “Donerion patch” for the treatment of Alzheimer's dementia jointly developed with Icure.

 

Donerion patch (Donepezil) is a product jointly developed by bio-venture Icure and Celltrion.

 

In June 2017, after Icure developed and completed the non-clinical and phase 1 clinical trials, it signed a joint domestic copyright contract with Celltrion.

 

Together with Icure, we conducted phase 3 clinical trials in about 400 patients with mild and moderate dementia in 4 countries including Korea, Taiwan, Australia, and Malaysia.

 

Donerion patch is an IMD developed by attaching the oral Donepezil once a day twice a week.

 

Compared to oral drugs, it is evaluated as a product that improves medication compliance and improves convenience.

 

Donepezil is the original medicine by Eisai's Aricept.

 

Celltrion said, "Donepezil is currently only commercialized for oral administration due to the difficulty in formulation development.

 

If the Donerion patch is approved by the Ministry of Food and Drug Safety, it will become the world's first Donepezil patch." Both companies are aiming to commercialize next year after acquiring an item license.

 

The clinical phase 3 of the Donerion patch was conducted for a total of 24 weeks in patients with mild and moderate Alzheimer's dementia.

 

Oral Donepezil or Donerion patch was administered by dividing into a group taking oral Donepezil 5 mg or 10 mg and a group who had never taken Donepezil.

 

Donepezil for oral administration by setting the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a representative standard tool for dealing with memory, language, reconstruction, behavior, and mentality, as a primary efficacy endpoint in mild and moderate Alzheimer's Contrast the Donerion patch proved its non-inferiority.

 

The non-inferiority of the Donerion patch compared to the oral Donepezil was also confirmed in the secondary efficacy endpoints CIBIC-plus, MMSE, CDR-SB, and NPI, which were additionally set to comprehensively evaluate the drug effect in terms of both cognitive and functional improvement.

 

did.

 

Donepezil is the most commonly prescribed ingredient in Alzheimer's dementia treatments.

 

According to UBIST, a drug market research organization, Donepezil accounts for about 30 billion won, 80% of the domestic sales of Alzheimer's dementia treatments in 2020, of about 290 billion won.

 

A Celltrion official said, "As Donerion was developed as the world's first Donepezil patch, it is expected to enter the market quickly with competitiveness differentiated from existing formulations if it obtains approval from the MFDS by improving patient convenience."