Avicanna Advances Pharmaceutical Epilepsy Program With Collaboration With the University Health Network and GMP Manufacturing of its First Pharmaceutical Preparation

Published: January 7, 2021

Avicanna Advances Pharmaceutical Epilepsy Program With Collaboration With the University Health Network and GMP Manufacturing of its First Pharmaceutical Preparation

Avicanna Inc., a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products, announced that the Company has entered into a master services agreement with the University Health Network (UHN) for projects to be performed by Dr. Peter Carlen as the principal investigator related to epilepsy. Additionally, the company has completed the technical transfer and first pharmaceutical pilot production of its epilepsy drug candidate at Altea Farmaceutica S.A. (“Altea”) in Bogota, Colombia, a major step required for the final preparation for its registration and commercialization in South America.

The epilepsy research collaboration is lead by Dr. Peter Carlen, who is a Senior Scientist at the Krembil Research Institute at UHN and a world-renowned researcher in the field of epilepsy. Dr. Carlen’s laboratory will be analyzing Avicanna’s RHO Phyto and pharmaceutical cannabinoid-based products (the “Products”) for their efficacy in the treatment of seizures. The partnership will also co-develop a high throughput electrophysiological testing system for the evaluation of multiple cannabinoid ratios and in combination with standard epileptic drugs. In addition, the system will examine standard anti-seizure drugs for their efficacy in the model and determine the potential synergistic value of adjunctive cannabinoids, and cannabinoids as monotherapy in treating seizures in this in vitro setting.

Dr. Peter Carlen commented: “The Carlen lab is very pleased to research the relationships between the premium medicinal cannabinoid products of Avicanna and their effects on epilepsy. Also, in collaboration with Avicanna, we are developing a high-throughput platform to assess these interactions. We think that medical cannabinoids will have a major impact on brain health, particularly as we gain greater understanding of their effects on brain function in health and disease.”

The services to be performed under the Master Services Agreement will be provided on an exclusive basis and Dr. Carlen’s laboratory has agreed to not conduct testing on any formulations or products similar to the Products for a period of two (2) years. All intellectual property created under the Master Services Agreement will remain the sole property of Avicanna. The research collaboration is further expanded to include electrophysiological studies of medical cannabinoids on 3D human cerebral organoids and neuroglial cultures with the support of a two-year Mitacs Accelerate program grant.

Avicanna also completed its first pharmaceutical level production of its first epilepsy drug candidate under GMP and ICH guidelines which are necessary for sanitary drug registration. The formulation developed by Avicanna includes active pharmaceutical ingredients which are cannabinoids produced by Avicanna’s subsidiary Santa Marta Golden Hemp S.A.S. The final GMP manufacturing took place at Avicanna’s exclusive manufacturing partner’s, Altea’s, facility in Bogota, which is a Health Canada and ANVISA (Brazil) approved GMP facility. The completion of this pharmaceutical production now allows Avicanna to proceed with drug registrations for epilepsy across several markets in South America including Colombia and Brazil.

Aras Azadian, CEO of Avicanna, commented: “We are pleased to demonstrate our dedication to world-class research and to take this stride in our epilepsy research program with a leading Canadian research institute and Dr. Carlen. This multi-level partnership will help to further study our current medical cannabis and pharmaceutical products, and will support the development and increase the depth of our pharmaceutical pipeline. Additionally, the completion of our first pharmaceutical production marks a milestone event in our drug development plans and highlights our capabilities to scale our drug formulations from bench top to industrial manufacturing.”

The Krembil Research Institute at Toronto Western Hosp​​ital at UHN is home to​ one of the world’s largest and most comprehensive teams of physicians and scientists uniquely working hand-in-hand to prevent and confront problems of the brain and spine. One in three Canadians will experience a brain-related condition such as Parkinson’s, Alzheimer’s or Stroke in their lifetime. Through state-of-the-art patient care and advanced research, we are working relentlessly toward finding new treatments and cures. ​

Mitacs is a not-for-profit organization that fosters growth and innovation in Canada by solving business challenges with research solutions from academic institutions. Mitacs is funded by the Government of Canada, the Government of Alberta, the Government of British Columbia, Research Manitoba, the Government of New Brunswick, the Government of Newfoundland and Labrador, the Government of Nova Scotia, the Government of Ontario, Innovation PEI, the Government of Quebec, and the Government of Saskatchewan.

Avicanna is a diversified and vertically integrated Canadian biopharmaceutical company focused on the research, development, and commercialization of plant-derived cannabinoid-based products for the global consumer, medical, and pharmaceutical market segments.