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By Anthony Termini, Benzinga
Back in the 1960s, a British pharmacologist discovered that aspirin had an effect on blood platelets that could reduce the risk of heart attacks and strokes. Unfortunately for patients, aspirin manufacturers couldn’t say that because of labeling requirements of the U.S. Food and Drug Administration (FDA).
While the FDA is a vital part of providing patients and consumers with safe products, there are also more archaic aspects of the administration. Despite the reality that botanical solutions have been around and trusted for thousands of years, botanical or natural drugs have long been excluded from FDA-approval. It was only in 2016 that the Center for Drug Evaluation and Research developed guidelines for new drug applications for botanicals. It described the process pharmaceutical and biotechnology companies should follow to get a botanical drug approved by the FDA.
AJNA’s Mission To Bring Natural Options To Market
AJNA BioSciences is among the biotech companies seeking FDA approval for its botanical product. The company is working to develop the world’s first FDA-approved full-spectrum cannabinoid drug and a robust pipeline of other plant medicines. However, the path to launching a new FDA-approved drug can be long. According to management consultants McKinsey & Company, it takes about 12 years to bring a drug to market. To optimize the process, McKinsey suggests that drug makers need to be nimble and agile.
AJNA BioSciences CEO Joel Stanley points out that “the botanical category is so new that only four FDA-approved botanical drugs exist to date.” Ajna hopes to break the mold and eventually introduce many FDA-approved botanical drugs to the market.
“AJNA BioSciences is the first biotech company to be working with botanicals under a DEA Schedule-1 license,” says Joel Stanley, the company’s CEO. This is a significant milestone for the company because FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective.
Additionally, FDA approval helps inform the Centers for Medicare & Medicaid Services, which is a critical step to getting a drug included on insurance reimbursement schedules. The company firmly believes in providing patients with a variety of options that are not only safe but affordable and available through insurance. Another one of AJNA’s goals is to make botanical drugs an accepted component of a physician’s and patient’s routine treatment options.
Demand for botanical solutions has been increasing for years, and AJNA’s strategy is to follow the same blueprint as large pharmaceutical companies that bring new drugs to market. Herbal medicine products are not considered a distinct regulatory category in the U.S., unlike Europe or Canada. Instead, a botanical drug is defined by its intended use in the treatment cycle of disease – like all other medicinal drugs. However, until recently, strict regulatory policy blocked the development of prescription drugs made from plants – this has now changed.
Obtaining FDA approval helps lead to greater physician advocacy. In other words, doctors have more tools at their disposal to help treat patients and are able to impact positive structural change to evolve treatment options.
AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.” Stanley says that this is part of why AJNA is “the first company to receive a plant variety protection patent for cannabis.” The company also understands that FDA approval will make more patients feel comfortable with trying a more unconventional approach to treatment; for patients who have only been exposed to synthetic drugs, botanical drugs may seem unfamiliar, but FDA approval minimizes those hesitations.
How Investors Might Evaluate AJNA’s Business
AJNA’s mission is to bring natural options to the pharmaceutical industry, and it is bringing a number of proprietary strengths to the proposition. The company reports that it enjoys a wide economic moat that serves as a barrier to potential competitors. Having already raised over $250,000 from a venture capital firm, the company is currently hosting a raise to help further its vision.
AJNA has established rigorous research and development processes with a strong team behind it. Its research facilities are registered with the FDA, with scientists from Harvard Medical, Johns Hopkins and NYU. Stanley is also an experienced CEO who has taken a similar company public. Chief Medical Advisor Orrin Devinsky helped obtain the first FDA approval for a cannabis-derived drug. Furthermore, AJNA’s research team has successfully shepherded more than 500 drug applications through the FDA process.
While the company is not looking to replace big pharma, it wants to offer patients more solutions. As Stanley points out, “By investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had. We come from nature, not a lab.”
More information is available on the Wefunder website.
Featured photo courtesy of AJNA BioSciences.
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