American BriVision (Holding) Corporation

Featured Company / American BriVision (Holding) Corporation

Some of the most popular drugs in the world are found in nature. Some fall into the recreational space – like coca leaves (cocaine) and blue agave (tequila) – while others have proven medicinal applications. With uses ranging from headaches to cancer, these drugs include ephedra sinica (Sudafed), willow bark (aspirin), opium poppy (morphine) and even the emerging field of psilocybin, to name just a few. In fact, Mother Nature has provided a treasure trove of plant sources that underpin over 100 top prescription drugs today.

American BriVision (Holding) Corporation (OTCQB:ABVC) is a company that believes it may have some new additions to that list with its ongoing work.  The Fremont, California-based company has a portfolio full of plant-based products for treating diseases that represent large areas of unmet medical need, including mid-stage clinical trials for depression and adult ADHD (attention deficit hyperactivity disorder).

Furthermore, ABVC is moving towards pivotal clinical trials for Vitargus, a medical device/gel used in vitreoretinal surgery, giving the microcap another partnering opportunity and pathway to revenue, provided, of course, positive phase 3 results and all approvals are ultimately received in the future.

Clearly Differentiated Where Big Pharma is Looking

Botanical-derived drugs are a clear differentiator for American BriVision versus many other biotechs. The seasoned management team has a focused strategic plan of identifying promising drug candidates originating in Asia-Pacific (APAC) region, leveraging its relationships with prestigious research hospitals in the U.S. (e.g., Stanford, UCSF, Sloan Kettering, Cedars-Sinai) to develop the drugs to the point that interest is generated with big pharma. At that point, the company is aiming to forge partnerships to share the responsibility of expensive late-stage studies, regulatory approval processes and marketing.

Historically, big pharma in North America didn’t show a great deal of interest in incorporating botanicals as part of drug development portfolios. However, that changed drastically during the past decade, as drug makers have turned some attention to active ingredients that frequently have a wider therapeutic index while carrying a better safety profile than small molecules and immunotherapies.

A couple of cases to this point include Sanofi (NYSE:SNY) acquiring BMP Sunstone in 2010 for $520 million and Bayer (OTC:BAYRY) buying Dihon Pharmaceuticals in 2014 for $586 million.

3 Shots on Goal, Large Market Opportunities

American BriVision’s most advanced products are ABV-1504, ABV-1505 and the aforementioned Vitargus (also known as ABV-1701). Both ABV-1504 and ABV-1505 contain the active ingredient PDC-1421, which comes from Polyhala tenuifolia, a plant that produces powerful compounds in its root system.

ABV-1504 is being researched initially – and delivering compelling data – as a therapeutic for MDD (major depressive disorder). According to the World Health Organization (WHO), in excess of 300 million people globally suffer from MDD, with a limited number of effective, safe treatment options. WHO opines that MDD in 2019 became the second most common disease in the world, while forecasting the drug marketplace for depression will top $18 billion by 2024.

Many anti-depressive drugs, including the household brands Prozac (fluoxetine) and Xanax (alprazolam), are known to have some potentially serious adverse side effects, not to mention the risk of addiction.

This is where ABV-1504 is starting to make a name for itself. American BriVision has completed both Phase I and Phase II clinical trials of ABV-1504 for MDD at Cedars-Sinai Hospital in Los Angeles, demonstrating safety and efficacy for the Norepinephrine Transporter (NET) Inhibitor. The Phase II trial – conducted by Stanford University and five major medical centers in Taiwan – was completed in 2019.

Notably, data from the trials showed ABV-1504 performing more effectively in treating MDD than Prozac (fluoxetine), as measured by the Montgomery-Asberg Depression Rating Scale, with zero serious adverse effects.

Better than a blockbuster like Prozac with no side effects? That has “company maker” potential. The onus is now on American BriVision to repeat the results in a large study either alone or with a partner. In order to hit the next milestone of initiating a Phase III study, the company is working to prepare for an “end of phase II” meeting with the FDA, which will help define future guidelines.

As for ABV-1505, the first indication being targeted is Adult ADHD. In June patient enrollment was completed in Part 1 of a Phase II clinical trial being conducted at the University of California San Francisco (UCSF) Medical Center. The small (6 patients), open-label study will elucidate on optimal dosing levels for future trials. In the study, each patient will receive a low-dose treatment (380 mg) thrice daily for 28 days followed by a high-dose treatment (760 mg) thrice daily for another 28 days.

Building on that data, a Phase II Part 2 study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part 1 study.

The global ADHD market was valued at $16.4 billion in 2018 and is estimated by Grand View Research to rise to $24.9 billion by 2025, propelled by increased awareness about mental health and governments actively taking steps to address the condition.

Much like the MDD clinical trials, no serious adverse events have been reported in early ADHD research.

Unlike ABV-1504/1505, which qualify as “drugs” in the eyes of the FDA, Vitargus is a medical device, making for a little less onerous FDA process to reach commercialization. Nearly two million people underwent vitreoretinal surgery in 2019 for the treatment of retinal detachment and vitreous hemorrhage. In every one of those cases, specialty surgeons replaced the patient’s vitreous humor (the gel-like substance in the eye) with a substitute.

Grand View Research predicts the global retinal surgery device market to be valued over $3.0 billion by 2025. 

Today’s substitutes have limitations and are ripe for innovation like Vitargus, a biodegradable, next-generation vitreous substitute that has significant advantages over the current medical treatments available to surgeons worldwide.

In October, ABVC presented these advantages at the American Academy of Ophthalmology conference. Benefits over legacy technologies include a one-day recovery, clearer vision following surgery, no need for a second surgery, a density higher than water (meaning patients don’t have to lie face down after surgery), and, probably most importantly, low thermal expansion coefficients that results in reduced intraocular pressure, and in turn reduces adverse side-effects to retinal tissue and vision recovery.

As is becoming a theme at ABVC, in-human trials showed the benefits without signs of toxicity or treatment-related serious adverse events. Patients receiving Vitargus experienced a statistically significant improvement from baseline in corrected visual acuity (BCVA).

By the end of 2020 or early 2021 at the latest, American BriVision intends to begin a pivotal trial for Premarket Approval from the FDA. In the study, the company plans to enroll patients with retinal detachment and vitreous hemorrhaging across several countries.

Biotech Incubator

ABVC has made it very clear that APAC is a big part of the playbook. This is because American BriVision’s management has deep roots in the region, including CEO Dr. Howard Doong who also serves as the CEO and Chief Scientific Officer of Taiwan-based LifeCode Biotechnology Company. Before founding ABVC, Chief Strategic Officer Dr. T.S. Jiang was a founder of AmCad Biomed and PhytoHealth. PhytoHealth developed the PG2 Lyo Injectable product for cancer patients having trouble recovering from severe fatigue. Dr. Jiang is also a director of various biotech associations, such as the Taiwan Bio Industry Organization and the Chinese Herbs and Biotech Development Association in Taiwan. Both organizations have been sources of promising drugs ABVC plans to bring to the market.

These leaders have kept the share structure extremely tight with less than 20 million shares outstanding, something it has been conscious of as it positions to one day matriculate to the NYSE or NASDAQ.

In many ways, American BriVision is a biotech incubator/accelerator in its strategy. There is a growing body of evidence that the lead products have the potential to one day capture share in large markets, with Vitargus the closest to the finish line at this point and many more than aforementioned in the pipeline.

Corporate Snapshot:
American BriVision (Holding) Corporation
Stock Symbol: ABVC
Stock Exchange: OTCQB
Sector: Healthcare
52 Week High: $11.5000
52 Week Low: $1.0500

Current Stock Quote / Chart / News: Click here

Information as of July 21, 2020

Some of the most popular drugs in the world are found in nature. Some fall into the recreational space – like coca leaves (cocaine) and blue agave (tequila) – while others have proven medicinal applications. With uses ranging from headaches to cancer, these drugs include ephedra sinica (Sudafed), willow bark (aspirin), opium poppy (morphine) and even the emerging field of psilocybin, to name just a few. In fact, Mother Nature has provided a treasure trove of plant sources that underpin over 100 top prescription drugs today.

American BriVision (Holding) Corporation (OTCQB:ABVC) is a company that believes it may have some new additions to that list with its ongoing work.  The Fremont, California-based company has a portfolio full of plant-based products for treating diseases that represent large areas of unmet medical need, including mid-stage clinical trials for depression and adult ADHD (attention deficit hyperactivity disorder).

Furthermore, ABVC is moving towards pivotal clinical trials for Vitargus, a medical device/gel used in vitreoretinal surgery, giving the microcap another partnering opportunity and pathway to revenue, provided, of course, positive phase 3 results and all approvals are ultimately received in the future.

Clearly Differentiated Where Big Pharma is Looking

Botanical-derived drugs are a clear differentiator for American BriVision versus many other biotechs. The seasoned management team has a focused strategic plan of identifying promising drug candidates originating in Asia-Pacific (APAC) region, leveraging its relationships with prestigious research hospitals in the U.S. (e.g., Stanford, UCSF, Sloan Kettering, Cedars-Sinai) to develop the drugs to the point that interest is generated with big pharma. At that point, the company is aiming to forge partnerships to share the responsibility of expensive late-stage studies, regulatory approval processes and marketing.

Historically, big pharma in North America didn’t show a great deal of interest in incorporating botanicals as part of drug development portfolios. However, that changed drastically during the past decade, as drug makers have turned some attention to active ingredients that frequently have a wider therapeutic index while carrying a better safety profile than small molecules and immunotherapies.

A couple of cases to this point include Sanofi (NYSE:SNY) acquiring BMP Sunstone in 2010 for $520 million and Bayer (OTC:BAYRY) buying Dihon Pharmaceuticals in 2014 for $586 million.

3 Shots on Goal, Large Market Opportunities

American BriVision’s most advanced products are ABV-1504, ABV-1505 and the aforementioned Vitargus (also known as ABV-1701). Both ABV-1504 and ABV-1505 contain the active ingredient PDC-1421, which comes from Polyhala tenuifolia, a plant that produces powerful compounds in its root system.

ABV-1504 is being researched initially – and delivering compelling data – as a therapeutic for MDD (major depressive disorder). According to the World Health Organization (WHO), in excess of 300 million people globally suffer from MDD, with a limited number of effective, safe treatment options. WHO opines that MDD in 2019 became the second most common disease in the world, while forecasting the drug marketplace for depression will top $18 billion by 2024.

Many anti-depressive drugs, including the household brands Prozac (fluoxetine) and Xanax (alprazolam), are known to have some potentially serious adverse side effects, not to mention the risk of addiction.

This is where ABV-1504 is starting to make a name for itself. American BriVision has completed both Phase I and Phase II clinical trials of ABV-1504 for MDD at Cedars-Sinai Hospital in Los Angeles, demonstrating safety and efficacy for the Norepinephrine Transporter (NET) Inhibitor. The Phase II trial – conducted by Stanford University and five major medical centers in Taiwan – was completed in 2019.

Notably, data from the trials showed ABV-1504 performing more effectively in treating MDD than Prozac (fluoxetine), as measured by the Montgomery-Asberg Depression Rating Scale, with zero serious adverse effects.

Better than a blockbuster like Prozac with no side effects? That has “company maker” potential. The onus is now on American BriVision to repeat the results in a large study either alone or with a partner. In order to hit the next milestone of initiating a Phase III study, the company is working to prepare for an “end of phase II” meeting with the FDA, which will help define future guidelines.

As for ABV-1505, the first indication being targeted is Adult ADHD. In June patient enrollment was completed in Part 1 of a Phase II clinical trial being conducted at the University of California San Francisco (UCSF) Medical Center. The small (6 patients), open-label study will elucidate on optimal dosing levels for future trials. In the study, each patient will receive a low-dose treatment (380 mg) thrice daily for 28 days followed by a high-dose treatment (760 mg) thrice daily for another 28 days.

Building on that data, a Phase II Part 2 study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part 1 study.

The global ADHD market was valued at $16.4 billion in 2018 and is estimated by Grand View Research to rise to $24.9 billion by 2025, propelled by increased awareness about mental health and governments actively taking steps to address the condition.

Much like the MDD clinical trials, no serious adverse events have been reported in early ADHD research.

Unlike ABV-1504/1505, which qualify as “drugs” in the eyes of the FDA, Vitargus is a medical device, making for a little less onerous FDA process to reach commercialization. Nearly two million people underwent vitreoretinal surgery in 2019 for the treatment of retinal detachment and vitreous hemorrhage. In every one of those cases, specialty surgeons replaced the patient’s vitreous humor (the gel-like substance in the eye) with a substitute.

Grand View Research predicts the global retinal surgery device market to be valued over $3.0 billion by 2025. 

Today’s substitutes have limitations and are ripe for innovation like Vitargus, a biodegradable, next-generation vitreous substitute that has significant advantages over the current medical treatments available to surgeons worldwide.

In October, ABVC presented these advantages at the American Academy of Ophthalmology conference. Benefits over legacy technologies include a one-day recovery, clearer vision following surgery, no need for a second surgery, a density higher than water (meaning patients don’t have to lie face down after surgery), and, probably most importantly, low thermal expansion coefficients that results in reduced intraocular pressure, and in turn reduces adverse side-effects to retinal tissue and vision recovery.

As is becoming a theme at ABVC, in-human trials showed the benefits without signs of toxicity or treatment-related serious adverse events. Patients receiving Vitargus experienced a statistically significant improvement from baseline in corrected visual acuity (BCVA).

By the end of 2020 or early 2021 at the latest, American BriVision intends to begin a pivotal trial for Premarket Approval from the FDA. In the study, the company plans to enroll patients with retinal detachment and vitreous hemorrhaging across several countries.

Biotech Incubator

ABVC has made it very clear that APAC is a big part of the playbook. This is because American BriVision’s management has deep roots in the region, including CEO Dr. Howard Doong who also serves as the CEO and Chief Scientific Officer of Taiwan-based LifeCode Biotechnology Company. Before founding ABVC, Chief Strategic Officer Dr. T.S. Jiang was a founder of AmCad Biomed and PhytoHealth. PhytoHealth developed the PG2 Lyo Injectable product for cancer patients having trouble recovering from severe fatigue. Dr. Jiang is also a director of various biotech associations, such as the Taiwan Bio Industry Organization and the Chinese Herbs and Biotech Development Association in Taiwan. Both organizations have been sources of promising drugs ABVC plans to bring to the market.

These leaders have kept the share structure extremely tight with less than 20 million shares outstanding, something it has been conscious of as it positions to one day matriculate to the NYSE or NASDAQ.

In many ways, American BriVision is a biotech incubator/accelerator in its strategy. There is a growing body of evidence that the lead products have the potential to one day capture share in large markets, with Vitargus the closest to the finish line at this point and many more than aforementioned in the pipeline.


Forward Looking Statements

This report includes forward-looking statements that reflect current expectations about its future results, performance, prospects and opportunities. American BriVision (Holding) Corporation has tried to identify these forward-looking statements by using words and phrases such as "may," "will," "expects," "anticipates," "believes," "intends," "estimates," "plan," "should," "typical," "preliminary," "we are confident" or similar expressions. These forward-looking statements are based on information currently available and are subject to a number of risks, uncertainties and other factors that could cause American BriVision (Holding) Corporation's actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. These risks, uncertainties and other factors include, without limitation, the Company's growth expectations and ongoing funding requirements, and specifically, the Company's growth prospects with scalable customers, and those outlined above. Other risks include the Company's limited operating history, the Company's history of operating losses, consumers' acceptance, the Company's use of licensed technologies, risk of increased competition, the potential need for additional financing, the terms and conditions of any financing that is consummated, the limited trading market for the Company's securities, the possible volatility of the Company's stock price, the concentration of ownership, and the potential fluctuation in the Company's operating results.

Disclaimer

AllPennyStocks.com feature stock reports are intended to be stock ideas, NOT recommendations. Please do your own research before investing. It is crucial that you at least look at current SEC filings and read the latest press releases. Information contained in this report was extracted from current documents filed with the SEC, the company web site and other publicly available sources deemed reliable. For more information see our disclaimer section, a link of which can be found on our web site. This document contains forward-looking statements, particularly as related to the business plans of the Company, within the meaning of Section 27A of the Securities Act of 1933 and Sections 21E of the Securities Exchange Act of 1934, and are subject to the safe harbor created by these sections. Actual results may differ materially from the Company's expectations and estimates. This is an advertisement for American BriVision (Holding) Corporation The purpose of this advertisement, like any advertising, is to provide coverage and awareness for the company. The information provided in this advertisement is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject us to any registration requirement within such jurisdiction or country.

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