Icure Pharmaceutical's Donerion Patch, a donepezil patch product to treat Alzheimer's, is attracting attention after receiving approval from the Ministry of Food and Drug Safety as the world's first such treatment last Friday.
According to industry insiders, expectations are high because donepezil accounts for 80 percent of the local Alzheimer's treatment market among the four major materials used for Alzheimer's treatment -- donepezil, rivastigmine, memantine, and galantamine – and a patch-type Alzheimer's treatment has shown great advantages compared to oral drugs in patient convenience.
The industry had confirmed the marketability of patch-type Alzheimer's treatment when Novartis launched Exelon (Ingredient: rivastigmine) in 2007. The treatment quickly replaced the oral drug and took over 90 percent of the rivastigmine market within six years of its launch.
Given such a precedent, experts believe that Donerion Patch will have a similar impact on the local donepezil treatment market.
The company has also partnered will Celltrion, one of the major biopharmaceutical companies, to market the drug in Korea, further raising anticipation for the drug's success in the local market.
Celltrion also expects Donerion Patch to become a new treatment option for elderly patients who have difficulty taking oral medications.
Experts say they do not doubt that Icure's treatment will change the local Alzheimer's treatment market but stopped short of throwing full support to its success in the U.S. market, which accounts for about half of the global donepezil market.
In April, Icure received approval for phase 1 clinical trials in the U.S. and is preparing to start full-scale research. If the company completes the clinical trial, it will be possible to apply for a product license in the U.S. only with the results of the phase 1 trial.
However, it is unlikely that the company's treatment will become the first donepezil patch in the U.S. market as its competitor, Corium, a U.S. pharmaceutical company, is undergoing approval review from the U.S. Food and Drug Administration. The agency will decide whether to approve the patch by March next year.
A local financial expert also agreed, saying the U.S. competitor might affect Icure's market share.
"While Icure's treatment will have competitiveness in overseas markets as the size of its patch is smaller than that of the Corium, it is highly likely that that the latter, which completed additional clinical trials in April this year, will receive FDA approval first," said Lee Jun-soo, an analyst for Prophet Asset Management, to Korea Biomedical Review.
Therefore, it will not be easy for Icure to preempt the U.S. market even if the company receives approval in the U.S., Lee added.