Ethicann Pharmaceuticals, Inc. was formed in May 2018, as a Canadian company, with office address at 250 6th Avenue SW, Suite #1620, Calgary, AB, T2P 3H7, Canada. The company has also formed a wholly-owned U.S. subsidiary, Ethicann Pharmaceuticals USA, Inc., located in Bethesda, MD, near the U.S. FDA campus.
The Company’s founding Board of Directors comprised six individuals, with extensive pharmaceutical and biopharma background, including almost 100 years of collective hands-on experience in global drug regulatory approvals in the U.S., Canada, Europe, Asia and Latin America. In addition, four of the co-founders were on the board of CanniMed Pharmaceuticals, one for over 20 years. Its predecessor company, Prairie Plant Systems, Inc., a Saskatoon-based company established in 1988, was the first medical marijuana company licensed in Canada. CanniMed was acquired by Aurora Cannabis, Inc. in March 2018. The co-founders were heavily engaged in negotiating this CAD $1.1 billion transaction and were unanimously drawn to follow this success—given their career backgrounds—to create a company to pursue the growing market for cannabinoid-based ethical pharmaceuticals as an early mover enterprise.
What Drives Ethicann
Ethicann sees the cannabinoid pharmaceutical market as a global market opportunity, with total market size above USD $100 billion by the end of the decade. In the U.S., Canada, Europe, and elsewhere, clinical development of regulated pharmaceuticals follows a traditional sequential process usually taking 8-14 years from R&D to market approval, with a cost per product of several hundred million US dollars. Only about 15-20% of such new drugs using this pathway ever achieve market entry. By contrast, Ethicann will take advantage of already approved cannabinoid pharmaceuticals, re-formulating existing active pharmaceutical ingredients (API’s) into a novel sublingual oral dissolving tablet, providing a number of safety and potential efficacy benefits, and will employ abbreviated regulatory pathways in the US, Canada, and elsewhere – thereby reducing time to market to as little as 3-5 years, with total development costs per product on the order of USD $20 million.
Ethicann Pharmaceuticals is targeting five different large-market diseases for its THC+CBD ethical pharmaceutical drugs; namely and in order of launch, spasticity from multiple sclerosis, chemotherapy-induced nausea and vomiting (CINV), chronic pain from cancer, post-traumatic stress disorder (PTSD), and opioid use disorder (OUD). Collectively, existing products for these indications are above USD $80 billion in current annual worldwide sales.
Ethicann is targeting launch of its first product, EPI-002 for treatment of spasticity from multiple sclerosis, by 2025.