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Drug discovery and development utilized by existing or already marketed drug product, including 505(b)2 path
We are developing drug products by conducting drug-repositioning approach, including 505(b)2 path. In many cases, small molecule compounds are screened in in vitro and following in vivo studies. Some compounds screened are further evaluated in disease-model animal studies and toxicology studies. The success rate of discovering a new drug is highly unlikely. The majority of drug candidates fail in toxicology studies with safety concerns. However, by utilizing existing or already marketed drug products, the safety risk of drug development is minimized because safety profiles of those drug products are already known. Furthermore, the discovery of a novel pharmacological effect in the existing drug products allows us to create intellectual property rights which will protect market exclusivity. For example, by changing administration routes, dosage forms, or formulation, we will get a chance to find a new pharmacological effect in an existing drug. By taking this approach, we are developing new drugs by utilizing an existing drug product.
These products are ready to meet unmet needs in significant drug markets. We are preparing initiation of clinical trials.
Patents which protects market exclusivity of AMD101 and SCR101 topical products have been issued in Japan and US, respectively. A new PCT patent application for AMD101 topical ophthalmic products has been published in Jun, 2022.
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