Canadian Companies Have Chance to Dominate Global Medical Cannabis Market.
Momentum Public Relations
Blog: March 21 2018
Tetra Bio-Pharma Receives FDA Orphan Drug Status for PPP001
Canadian Companies Have Chance to Dominate Global Medical Cannabis Market.
Grand View Research has predicted that the global medical marijuana market will reach US$55.8 billion by 2025.
When licensed medical marijuana producers first began to list on the Canadian stock exchanges they received sky high valuations.
Some analysts and producers looked beyond the domestic market and wondered if the legalization of marijuana in Canada would allow Canadian marijuana growers to take a dominant position in the global market as marijuana legalization rolled out around the world.
It now looks as if Canada stands a good chance to become a global leader in the development of cannabinoid-based drugs and the regulatory approvals that ensure their safety and efficacy.
The cannabinoid-based drug market is going to be huge. Grand View Research has predicted that the global medical marijuana market will reach US$55.8 billion by 2025.
A Bloomberg News story published in the Financial Post on December 28, 2017 explains why Canadian medical cannabis producers and drug companies are set to move onto the global stage.
The established use of medical cannabis in Canada and the legalization of recreational marijuana both play a part in this.
Canopy Growth CEO Bruce Linton was quoted in the story as saying that the theme for 2018 will be the globalization of medical cannabis. One of Canada’s first medical marijuana producers, Canopy already ships to Germany and has partnerships with companies in Australia, Spain and Jamaica.
In effect, Canada has first mover status on the international market and if domestic producers do the right things they stand a good chance of dominating the global market.
While medical cannabis is now being prescribed in a variety of jurisdictions, it is only being prescribed because of anecdotal evidence. There is no scientific proof that medical cannabis-based therapeutic treatments work. The pharmaceutical companies that succeed in providing regulatory approval backed by hard science stand to profit with a very large market share.
Canada is leading the way because while one might assume that research powerhouse the United States would be at the head of the line, American research is hamstrung by the fact that while legal in many states, it is not legal at the American federal level. This means that federal research funding is not available.
Against that backdrop Canadian biopharmaceutical research and development company Tetra Bio-Pharma, dedicated to becoming the first to prove the safety and efficacy of cannabis-based drugs, has received funding from the National Science and Research Council of Canada.
The company has already started a Phase 3 clinical study designed to prove the safety and efficacy of its flagship product, smokable PPP001, designed as a therapeutic treatment for chronic and cancer pain. The company believes that PPP001 will be on the market no later than 2019.
Canada’s ability to lead the international pack when it comes to the development of cannabis-based therapeutic drugs can be illustrated by two recent developments.
On March 14, 2018 Tetra Bio-Pharma announced that it had received “Orphan Drug Status” for PPP001, for the treatment of Complex Regional Pain Syndrome by the American FDA.
Orphan drug status is a designation used to encourage research into drugs for the treatment of rare diseases that affect only a small percentage of the population, 200,000. It provides a seven year marketing exclusivity for the orphan drug.
Tetra Bio-Pharma is a biopharmaceutical company dedicated to providing the science that will prove that medical cannabis-based drugs are safe and actually work.
Unless a dark horse dramatically emerges, Tetra Bio-Pharma will also be the first biopharmaceutical to be granted Health Canada and FDA approvals, which in return will grant the approved drugs a Drug Identification Number, DIN. DIN numbers allow the drug to be prescribed by doctors, sold by pharmacies and covered by insurance plans.
DIN numbers are the Holy Grail in pharmaceutical research. Once you have them your products are legal to market. Without a DIN number they can’t be sold.
Tetra has a pipeline of cannabis-based drugs under development and has recently created a veterinary division to create cannabis-based drugs for the lucrative cat and dog market.
The company has also just announced its first European foray with partner PS Innovations. PS Innovations manufactures Tetra’s trademarked RX Princeps Inhalation Device. Tetra announced on March 6, 2018 that PS Innovations will apply for CE Marking, a process that guaranties the product conforms to European regulations and can be sold in the European Economic Area where it will be listed as a Class 1 Medical Device.
Another indication that Canada stands a good chance of leading the medical cannabis world is the recent agreement between Sandoz Canada and licensed medical marijuana producer Tilray Inc. On March 19, 2018, Tilray announced that it had formed an exclusive partnership with Sandoz Canada to develop non-smokable cannabis-based therapeutic drugs delivered through gel caps or lotions.
Sandoz is owned by Novatis and the agreement represents big pharma’s first venture into developing cannabinoid-based therapeutic treatments.
Pascal Biosciences discovered certain cannabinoids that help our immune system kill tumor cells.
Canopy Growth also has a medical division that holds a number of patents. If Canada can develop the momentum that comes with first mover status there is a good chance that it can dominate the global medical cannabis market.
- Published in Blog