ABVC BioPharma receives Australian patent for treatment of MDD

ABVC BioPharma received an Australian patent, valid until 2040, Application No. 2021314052, for the use of PDC-1421, a Radix Polygala extract, used in the Company’s asset ABV-1504 for the treatment of Major Depressive Disorder. The Company was previously awarded a U.S. patent, US 11,554,154 B2, on April 25, 2023, for the same treatment. The patent application was submitted to the Australian Patent and Trademark Office under “Polygala Extract for the Treatment of Major Depressive Disorder.” The invention relates to oral administration of the formulation containing a Radix Polygala extract, PDC-1421, as a capsule for treating Major Depressive Disorder. Based on the Company’s current internal studies, administering the composition should be done over at least 25 days, with the daily dose varying once, twice, or three times per day; each dose ranges between 380-760 mg of the botanical extraction. ABV-1504, the Company’s asset indicated for use in MDD containing PDC-1421, is a botanical-based Norepinephrine Transporter inhibitor that has completed Phase II clinical studies, with plans to initiate an End of Phase II meeting with the FDA. The CNS drugs with the indications of MDD and ADHD have been valued globally at $667M by a third-party valuation company and licensed to AiBtl BioPharma on November 12, 2023 by entering into a definitive global licensing agreement. According to the terms of the agreement, AiBtl delivered 46M shares to the Company as the first milestone payment. The Company expects AiBtl to achieve the further milestones under the agreement, upon which the Company may receive the remaining licensing fees of up to $7M cash and 5% royalties of net sales, up to $200M.