Pursuit of Large & Growing Markets
Ethicann Pharmaceuticals is targeting five different disease markets 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, post-traumatic stress disorder (PTSD), and opioid use disorder (OUD). Collectively, these markets are above USD $80 billion in current annual worldwide sales – the primary markets being North America and Europe, while Ethicann will penetrate global markets through partnerships.
Global Strategy for Rapid Approval through Accelerated Regulatory Pathways
Ethicann sees the cannabinoid pharmaceutical market as a global marketing opportunity and will leverage U.S. and Canadian clinical studies as a basis to seek regulatory approval of its products around the world. In the U.S. and Canada, clinical development of regulated pharmaceuticals follows a traditional sequential process usually taking 8-14 years from R&D to market approval. Only about 15-20% of such new drugs using this pathway ever achieve market entry. In contrast, Ethicann will be using the abbreviated FDA (505(b)(2) NDA/ANDA and the Health Canada (HC) Submission Relying upon Third Party Data -New Drug Submission processes (SRTD-NDS) for its first products, reducing time to market to as little as 3-5 years.
In Europe, the Company will also explore the availability of rapid development and approval processes available through the European Medicines Agency (EMA), utilizing for submissions the clinical data generated under Canada CTAs in compliance with Good Clinical Practices (GCP).
In Latin America (“LATAM”–total population over 650 million), the largest markets are Brazil and Mexico. An Ethicann licensee in Mexico would lead registration with the Mexican regulatory authority (COFEPRIS), which employs procedures very similar to the EMA, but also follows certain FDA prescripts. Clinical trials compliant with FDA, HC and EMA standards can be readily conducted in Mexico with results there deployable in all four regulatory venues.
Importantly, COFEPRIS has memoranda of understanding with five Central American and six South American countries. Thus, an approved product registration in Mexico can be easily transported to almost 50% of the LATAM population (300+ million).
As part of a global regulatory strategy for rapid expansion, Ethicann will use clinical data from approvals obtained in the U.S., Canada, LATAM, and Europe for marketing approvals in many non-western countries. Where separate market approvals may need to be obtained, such as in China, Japan, Australia, India and South Korea, the U.S. and Canadian clinical data can be used as a basis for such approvals.
The 505(b)(2) New Drug Application (NDA)
A 505(b)(2) New Drug Application (NDA) contains full safety and effectiveness reports, but allows this information to come from studies not conducted by or for the applicant but by a preceding or originator applicant. A 505(b)(2) NDA cites full animal and human safety and efficacy data in the originator’s full 505(b)(1) NDA. The 505(b)(2) pathway is much less expensive and a faster route to approval, saving years compared with a traditional full 505(b)(1) NDA pathway.
The Submission Relying upon Third Party Data (SRTD) pathway
Health Canada’s Submission Relying upon Third-Party Data (SRTD) provides sponsors with a pathway to market authorization for globally marketed products having extensive post-market safety data. It requires performing bioequivalence studies comparing—to use a specific case planned by Ethicann—the Company’s EPI-002 product for MS-spasticity with the already-marketed Jazz Pharmaceuticals’ (GW Pharmaceuticals’) Sativex® product.