ABVC BioPharma Receives Notice of Allowance from US Patent and Trademark Office for ABV-1504 Used to Treat Major Depressive Disorder (MDD)
ABVC Biopharma, Inc. (NASDAQ: ABVC) announced a Notice of Allowance for its patent ABV-1504, aimed at treating Major Depressive Disorder using Radix Polygalae extract. This patent extends the protection for ABV-1504 in the US until 2041, allowing for global commercialization without generic competition. The drug has shown safety and tolerability in trials with doses ranging from 380 mg to 3800 mg. The antidepressant market is projected to grow from $13.69 billion in 2018 to $15.88 billion by 2025, highlighting potential market opportunity for ABVC's therapeutic solutions.
- Notice of Allowance for ABV-1504 patent extending protection until 2041 in the US.
- Patented drug shows safe and tolerable results in clinical trials.
- Potential risks in securing regulatory approval for clinical trials.
FREMONT, CA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that on October 20, 2022, it received a Notice of Allowance for ABV-1504 from the US Patent and Trademark Office.
The patent, entitled “Polygala Extract for the Treatment of Major Depressive Disorder,” outlines a method for treating major depressive disorder by oral administration of a composition, ABV-1504, containing Radix Polygalae (Polygala tenuifolia Willd). The polygala extract, designated PDC-1421, is the key active ingredient in ABV-1504 which was orally administered to healthy volunteers and proved to be safe and well-tolerated for a daily dose from 380 mg to 3800 mg. The study indicated that the drug can be administered chronically over at least 25 days with the daily dose administered once per day, twice per day, or three times per day, wherein each dose contains from 380 mg to 760 mg of the botanical extraction.
In addition to the United States, the patent was also filed in China, Taiwan and under the Patent Cooperation Treaty (PCT). The PCT patent application was published on January 27, 2022, and subsequently was filed in Japan, Australia and with the European Patent Office (EPO).
“The new patent substantially extends the existing patent life of ABV-1504 to the year 2041 in the US,” said Dr. Howard Doong, ABVC chief executive officer. “Furthermore, we expect the patent will be granted in China, Taiwan, Japan, Australia and European countries, all of which allows us to commercialize our CNS drugs globally without generic product competition.”
The Antidepressant Drugs Market is valued at USD 13.69 Billion in 2018 and expected to reach USD 15.88 Billion by 2025 with the CAGR of
About ABVC BioPharma
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, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
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. 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.
Contact:
Leeds Chow
CFO
Email: leedschow@ambrivis.com
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