ABVC BioPharma Receives Australian Patent, Valid Until 2040, for Its Treatment of Major Depressive Disorder (MDD)

Rhea-AI Summary

ABVC BioPharma, Inc. (NASDAQ: ABVC) secures Australian patent for PDC-1421 extract for Major Depressive Disorder treatment until 2040. The Company's asset ABV-1504, a botanical-based NET inhibitor, completes Phase II studies for MDD. ABVC enters global licensing agreement with AiBtl BioPharma Inc. for CNS drugs, expecting significant revenue potential.

Pharmaceutical Patent Expert

The recent acquisition of an Australian patent by ABVC BioPharma for PDC-1421, a treatment for Major Depressive Disorder (MDD), represents a significant strategic advancement in the company's intellectual property portfolio. The protection of novel therapeutics through patents is crucial in the pharmaceutical industry, as it provides a company with exclusive rights to commercialize their products, thus potentially blocking competitors and allowing for the recoupment of research and development investments. The dual patent coverage in both the United States and Australia until 2040 establishes a strong market position in these regions and could act as a deterrent against generic competition for an extended period post-commercialization.

Furthermore, the botanical nature of PDC-1421 as a Norepinephrine Transporter (NET) inhibitor could differentiate it in the market, given the current trend towards plant-based and 'natural' treatments. The completion of Phase II clinical studies and the upcoming End of Phase II meeting with the FDA indicate that the drug is progressing through the necessary regulatory milestones, which is a positive indicator for investors monitoring the company's pipeline progression.

Financial Analyst

The licensing agreement between ABVC BioPharma and AiBtl BioPharma Inc., involving an initial payment of 46M shares and potential further licensing fees up to $7M plus royalties, is a pivotal financial development. This agreement not only provides immediate non-dilutive capital to ABVC but also aligns future revenues with the commercial success of ABV-1504. The milestone payments and royalties are a common strategy in the biopharma industry to mitigate risk and finance ongoing development without resorting to additional equity financing, which could dilute existing shareholders.

Investors should note the potential market size for MDD treatments, valued at $11.51 billion in 2022 with a forecasted growth to $14.96 billion by 2032. The growth rate, while modest compared to other therapeutic areas, still presents a significant opportunity for ABVC if ABV-1504 can capture a portion of this market. The financial implications of the drug's success could be substantial, considering the royalty agreement terms and the large addressable market.

Market Research Analyst

ABVC BioPharma's entry into the MDD and ADHD treatment markets should be evaluated against the backdrop of current market dynamics and future growth projections. With a Compound Annual Growth Rate (CAGR) of 2.8% for the MDD market and a more robust 7.1% for the ADHD treatment market, ABVC's strategic positioning with ABV-1504 could allow them to tap into these expanding markets effectively. The company's focus on a botanical-based NET inhibitor could resonate well with patient populations and physicians seeking alternative treatment options beyond the traditional synthetic pharmaceuticals.

However, it is important to consider the competitive landscape, which includes numerous established pharmaceutical companies and emerging biotechs. The success of ABVC's product will depend on its efficacy, safety profile and the ability to differentiate itself in a crowded market. The licensing agreement with AiBtl BioPharma Inc. suggests confidence in the product's potential, but the actual market penetration and adoption rates will ultimately dictate the financial performance and impact on the company's stock valuation.

FREMONT, CA , Feb. 12, 2024 (GLOBE NEWSWIRE) -- The Company holds a U.S. patent for the same treatment

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
Email: leedschow@ambrivis.com

[1] https://www.futuremarketinsights.com/reports/major-depressive-disorder-treatment-market#:~:text=The%...
[2] https://www.prnewswire.com/news-releases/global-attention-deficit-hyperactivity-disorder-adhd-market...

What patent did ABVC BioPharma, Inc. receive in Australia?

ABVC BioPharma, Inc. received an Australian patent for the use of PDC-1421 extract in treating Major Depressive Disorder (MDD) until 2040.

What is the asset ABV-1504 developed by ABVC for?

ABV-1504 is a botanical-based Norepinephrine Transporter (NET) inhibitor developed by ABVC for the treatment of Major Depressive Disorder (MDD).

What phase of clinical studies has ABV-1504 completed?

ABV-1504 has completed Phase II clinical studies for Major Depressive Disorder (MDD).

What licensing agreement did ABVC enter into with AiBtl BioPharma Inc.?

ABVC entered into a definitive global licensing agreement with AiBtl BioPharma Inc. for CNS drugs, delivering 46M shares as the first milestone payment.

What is the expected revenue potential for ABVC from the licensing agreement with AiBtl?

ABVC may receive up to $7M cash and 5% royalties of net sales, up to $200M, from the global licensing agreement with AiBtl BioPharma Inc.