• The Company holds a U.S. patent for the same treatment

FREMONT, CA , Feb. 12, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, announced today that it received an Australian patent, valid until 2040, Application No. 2021314052, for the use of PDC-1421, a Radix Polygala (Polygala tenuifolia Willd) extract, used in the Company's asset ABV-1504 for the treatment of Major Depressive Disorder (MDD). The Company was previously awarded a U.S. patent, US 11,554,154 B2, on April 25, 2023, for the same treatment.

"These patents grant ABVC the right to exclude others from using, offering, or selling PDC-1421 throughout the United States and Australia until 2040," said Dr. Uttam Patil, ABVC Chief Executive Officer. "As our patent map steps into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan, and more."

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 (Polygala tenuifolia Willd) 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 (NET) inhibitor that has completed Phase II clinical studies, with plans to initiate an End of Phase II (EOP II) meeting with the FDA. The CNS drugs with the indications of MDD and ADHD (Attention Deficit Hyperactivity Disorder) have been valued globally at $667M by a third-party valuation company and licensed to AiBtl BioPharma Inc. (“AiBtl”) 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.

We believe the Company's pipeline products have great market potential. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032 with a CAGR of 2.8% over the forecast period.[1] According to the Polaris market research report, the global ADHD treatment market was valued at $16.13 billion in 2022 and is expected to reach $32.14 billion by 2030 with a CAGR of 7.1% over the forecast period.[2]

About ABVC BioPharma & Its Industry

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company's network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.

Forward-Looking Statements

This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential," or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Contact:
Leeds Chow
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