On December 19, Aribio announced that it had received a notice of patent registration from the United States Patent and Trademark Office (USPTO) regarding the mechanism of action (MoA) of AR1001, its oral Alzheimer's disease treatment candidate currently undergoing global Phase 3 clinical trials.
The company stated that this means the poly-pharmacology mechanism of AR1001 has been recognized by U.S. patent authorities for its originality and innovation. The value of a new drug is determined by the duration of exclusivity and the terms of technology transfer, and with this patent registration, AR1001 is considered to have strengthened its competitiveness on both fronts.
Through this patent registration, Aribio has secured grounds to effectively extend the exclusivity period for AR1001. Additionally, the company is now able to mitigate the risk of a patent cliff, which often arises in new drug development when the remaining patent period becomes short by the time of market launch.
AR1001 has secured an exclusivity period until 2040, and with the application of country-specific patent term extension systems, this could be extended to as late as 2043. If the Phase 3 trial is successful and the drug is launched, the company expects to reduce the threat of generic entry for more than 15 years after launch, maintaining control over pricing policies and sales strategies.
Jaejoon Jung, CEO of Aribio, stated, "The multi-mechanism technology of AR1001 has been officially recognized in the United States, the world's largest pharmaceutical market. Based on this long-term exclusivity, we have established a foundation to maximize corporate value in licensing-out deals with global pharmaceutical companies, and we are continuously filing additional patents for lifecycle management (LCM)."
AR1001 is based on PDE5 inhibition, which improves cerebral blood flow and suppresses neuronal cell death, while autophagy activation promotes the removal of toxic proteins. The company emphasized that the significance of this patent registration lies in the recognition not only of the theoretical mechanism but also of its potential therapeutic contribution and differentiation.
An Aribio representative stressed, "Patents are core assets directly linked to the profitability of new drugs. We expect that, in addition to the commercial value of AR1001, our negotiating power will be enhanced, allowing us to design more favorable terms for upfront payments, milestones, and royalties in global partnerships."
Meanwhile, Aribio is pursuing a merger with SorookS, a KOSDAQ-listed company. The scheduled merger date is February 24, 2026.
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