Fremont, CA - (NewMediaWire) - August 24, 2020 - American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that on July 22, 2020, it had filed with the US Patent and Trademark Office (“USPTO”) a new patent for the treatment of Major Depressive Disorder. It has been assigned serial number US 16/936,032.
The patent application, entitled “Polygala Extract for the Treatment of Major Depressive Disorder,” outlines a method for treating major depressive disorder by the patient’s oral administration of a composition containing Radix Polygalae (Polygala tenuifoliaWilld) extract (PDC-1421). A solid dosage form of PDC-1421 can be prepared into the gelatin capsule. The oral administration of PDC-1421 in healthy volunteers was proved to be safe and well-tolerated for the daily dose from 380 mg to 3800 mg. The composition can be administered chronically over at least 25 days; the daily dose can be administered once per day, twice per day, or three times per day, wherein each dose is 380 - 760 mg of the botanical extraction.
The company said the patent application was also filed in Taiwan and will be filed under the Patent Cooperation Treaty (PCT) within the 12-month period that has a legal effect in the contracting states of PCT.
“We believe this new patent, when granted, will greatly enhance our existing patent portfolio of Polygala tenuifoliaWilld extract (PDC-1421),” said Dr. Howard Doong, ABVC chief executive officer. “It will serve to strengthen our global IP position for the treatment of major depressive disorder and provide product exclusivity through 2040.”
Dr. Doong emphasized the importance of ABVC’s focus on botanical sourcing in drug development. “Our clinical trials continue to demonstrate that medicines derived from plants have significant therapeutic benefits with few - if any - side effects in treating serious medical conditions.”
About American BriVision
American BriVision is a clinical-stage biopharmaceutical company 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). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative and illiquid, and there is a risk of loss.
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. 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; (v) clinical trial results and additional analysis of existing clinical data; and (vi) 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.
Andy An – Chief Financial Officer