Given the high cost and time required to complete conventional drug development, entrance into the pharmaceutical market is challenging. Blockbuster drugs can take many years of painstaking research and cost in the billions of dollars in terms of acquiring talent, lab resources, intellectual property, clinical trials and regulatory approval. That’s before you even get to market. All this work could be completed and die on the bench due to any one of these steps not panning out. In the unlikely event that you have picked a winner, the only option is to out-license to a big pharmaceutical company. All very daunting and easy to see why so many ventures such as this fail.
Without access to large sums of cash or many years to market, the Principals at Biosential chose a somewhat simpler path.
A simpler path, not necessarily the easy route.
Biosential’s goal is develop treatments for common Central Nervous System (CNS) disorders but minimize risk following a three phase approach:
Development and sale of scientifically sound “near pharmaceuticals” for CNS disorders. Sale of near pharmaceuticals allows relatively quick access to markets giving Biosential market credibility and cash flow:
Utilizing the same method of action of “near pharmaceuticals”, re-purposed older pharmaceuticals will be identified and offered to sale for treatment of CNS disorders, especially for the treatment of Cognitive Impairment. The FDA grants a ten year exclusive market to companies that re-purpose older medications.
In licensing of medications that have already have phase three FDA approval.
Current Market Presence (Phase 1 – Proof of Market Concept)
At present, Biosential manufactures and sells ZenBev®and RestBites® natural food products that promote restful sleep, decreased anxiety and increased libido. The original patents for Zenbev® were filed in the USA given the size of that market. Biosential now has twenty-four patents granted to protect its Intellectual Property (IP). International patents have been granted worldwide including: Australia, Canada, China, Denmark, France, Germany, Hong Kong, Ireland, New Zealand, South Africa, Sweden and the United Kingdom with over 50 additional patents pending.
The proprietary formulation has been rigorously tested in double-blind placebo controlled studies for the treatment of anxiety disorders and insomnia. After publication of patents, clinical studies were published in respected peer-reviewed journals.
The underlying pharmacology of current products is consistent with the overall corporate strategy. The sleep benefits of synthetic tryptophan have been known for some time. Zenbev was developed as a natural “near pharmaceutical” to compete in markets were synthetic tryptophan is banned. These products competes well against other natural remedies in these markets.
Somewhat surprisingly, Zenbev also sells well in markets where synthetic tryptophan was subsequently allowed back onto the market.
The market for truly effective natural sleep and anxiety products increase as the risks associated with traditional sleep medications are appreciated and reported. A large scale study of 10,000 subjects in the respected medical journal, the British Medical Journal demonstrates a six fold cancer risk in patients taking traditional prescribed and OTC sleep medications.
At this time, Zenbev is sold exclusively in the natural health channel of Over the Counter (OTC) market. Biosential has mastered several key internet marketing and sales techniques which can easily be applied to each new product.