Donepezil patch has been applied for permission

The MFDS demands Phase III clinical trial

Donepezil patch (Source: Icure)

While Icure applied for permission for the world's first dementia treatment Donepezil patch, it was found that domestic competitors are still in the Phase I stage.

 

Icure is expected to preoccupy the domestic market if it obtains a license because it is faster to commercialize than its competitors.

 

In particular, Donepezil is most often used for the treatment of dementia, and due to the characteristics of dementia patients, it is expected that it will become a competitive drug for the original Aricept because it is a patch formulation that is applied rather than an oral formulation.

 

On the 13th, Icure and Celltrion announced that they applied for an item license for Donerion patch for Alzheimer's dementia treatment with the MFDS.

 

The Donerion patch was developed by Icure, and after completing phase I clinical trials, a joint domestic copyright contract was signed with Celltrion.

 

Icure conducted phase III clinical trials in about 400 patients with mild and severe dementia in four countries, including Korea, Taiwan, Australia, and Malaysia, proving non-inferiority compared to oral Donepezil.

 

Donepezil patch is currently not commercialized worldwide.

 

Icure will begin applying for permits in Korea and will proceed with worldwide development.

 

In March, the US FDA applied for a phase I trial protocol.

 

The sales volume of the domestic Donepezil market is about ₩230 billion, and the global market is known to be around ₩7 trillion.

 

Because the patch has good patient compliance, it is expected to rapidly erode the market share of existing oral drugs.

 

After launch, Icure aims to achieve 50% of the domestic market share of Donepezil.

 

In particular, as it is ahead of competitors in terms of commercialization speed, Icure is expected to dominate the market through patch formulation.

 

Domestic pharmaceutical companies that are currently developing the Donepezil patch are Dong-A ST, Daewoong, and Boryung.

 

The three companies are currently in phase I.

 

In the case of Dong-A ST, both clinical phase Ia to evaluate safety, tolerability, and pharmacokinetic characteristics when administered once and phase Ib to evaluate safety, pharmacokinetic and pharmacokinetic characteristics during repeated administration have been completed.

 

Initially, Dong-A expected that it would be possible to apply for permission if it confirmed equivalence through Phase I clinical trials, but it is known that the MFDS is also requesting long-term safety data.

 

In addition, since Icure applied for approval through phase III clinical trials, if the application for approval was accepted only in phase I clinical trials, it is expected to raise issues in terms of equity.

 

Dong-a is also preparing for clinical trials in India.

 

Boryung has completed Phase Ia clinical trials and is analyzing the results.

 

Boryung has also conducted joint development with Icure in the past, but has now moved to Celltrion.

 

Instead, Boryung is working with Raphas on commercialization development.

 

In May of last year, it took its first clinical steps.

 

Daewoong was approved for Phase I clinical trial in July 2019, but it is said that it has not been completed.

 

If the MFDS demands them for phase III clinical trials, the completion of commercialization will be further delayed.

 

Therefore, if Icure and Celltrion receive product approval, the possibility of preoccupying the market as the first product will increase.

 

Since the patch is a product that competes with original Aricept, it is expected to lead the entire dementia treatment market.