Korean pharmaceuticals and biotech companies are speeding up the development of donepezil patches to treat Alzheimer’s disease. As patches are easier for patients to take than oral drugs, they draw attention to how they will affect the dementia market.

Teaming up with Celltrion, Icure Pharmaceutical has neared the commercialization of the patch-type donepezil.

Icure, the developer of the patch, is waiting for the results of the review of the Ministry of Food and Drug Safety (MFDS) after applying for the marketing approval for the donepezil patch in April.

As the final step of the commercialization, Icure and Celltrion signed an agreement on Aug. 20 to sell Donerion Patch exclusively in the domestic market.

Celltrion has been supporting Icure’s global phase 3 trial of the donepezil patch since 2017.

Celltrion secured the right to sell Donerion Patch for about 12 years in Korea with the latest agreement. After that, icure will manufacture and supply the product.

The two companies expect that the patch, applied twice a week, will improve patient compliance compared to pills taken once a day.

Dong-A ST is working on a once-a-week patch DA-5207. In addition, the company completed a local phase 1 study and is conducting a bioequivalence test.

According to the National Institute of Food and Drug Safety Evaluation’s guidance published in November 2018, if a donepezil patch proves bioequivalence with oral donepezil, the patch developer does not have to conduct a confirmatory trial to prove the efficacy. However, the company has to test the patch in a phase 3 trial to evaluate safety.

“We are analyzing data from a bioequivalence test. We can submit safety data regarding long-term use of the patch later,” an official at Dong-A ST said. “The company is discussing a plan for a safety test, and we will also consult with the MFDS.”

Dong-A ST is also preparing a trial in India to secure Caucasian data.

Boryung Pharmaceutical is also developing donepezil patch BR4002, jointly with microneedle developer Raphas. BR4002 is a “microarray” transdermal absorbent that can deliver a high proportion of the active ingredient without damaging the skin, the company said.

Boryung signed an MOU with Raphas for joint research of microstructures in 2016, obtained the MFDS’ approval for the phase 1 trial of BR4002 in May, and completed the trial in July.

In the phase 1 study, Boryung compared the pharmacokinetic properties, safety, and tolerability of the patch BR4002 with the oral drug BR4002-1 in 18 healthy adults.

“We plan to report the phase 1 trial results to the MFDS,” an official at Boryung said.

Donepezil is the most prescribed agent among treatments for Alzheimer’s disease.

According to UBIST data, donepezil sales marked 230 billion won ($197.4 million) last year, accounting for 80 percent of the domestic sales of Alzheimer’s treatments (290 billion won).