SatiPharm, MMJ’s Swiss subsidiary has completed the development of Sativol, a proprietary gastro-resistant Cannabidiol (CBD) pill that being launched in Europe as dietary supplement, with first revenues from pill sales anticipated from August 2015.
Sativol was developed under the exclusive partnership with Good Manufacturing Practice (GMP) approved Swiss partners AiFame GmbH, an integrated cannabis-focused pharmaceutical compound manufacturer and Gelpell AG, a premium contract manufacturer of supplements and phyto-pharmaceuticals.
MMJ PhytoTech is working in partnership with Canigma to develop a capsule based vaporiser. The device is based on an all-in-one product, with ready to use cannabis capsules. The capsule provides minimal contact between the consumer and the raw material and will be focused on increasing the therapeutic efficiency through conduction and convection heating technologies. Medical practitioners will be able to provide prescriptions based on capsules that have a defined ratio of THC and CBD and will have better control over the dosage.
III. Oral capsule for the treatment of pain and spasticity of Multiple Sclerosis
PhytoTech Therapeutics is working with its partner Yissum Research Development Company to develop unique oral capsules to treat pain and spasticity of Multiple Sclerosis. The soft gelatine capsules contain a 1:1 ratio of the active components THC:CBD, a unique formulation capable of significantly reducing drug metabolism by the digestion system resulting in high drug absorbance, which has been previously difficult to achieve due to the drugs low bioavailability.
Multiple Sclerosis is a disabling lifelong disease, which attacks the central nervous system. It affects more than 1.2 million people worldwide and spasticity is one of the most common and most disabling symptoms, affecting up to 84% of patients.
One of the most successful treatments for Multiple Sclerosis pain and spasticity was found to be the use of a safe and tolerable combination of THC and CBD as 1:1 ratio. Although the therapeutic rationale for the THC and CBD combination has been established, an optimal oral dosage form is not yet available due to the substantial “first pass” metabolic effect of the cannabinoids in the gastrointestinal tract leading to very limited oral bioavailability of 6%.
Our oral capsule formulation demonstrated in pre-clinical studies significantly enhanced the bioavailability of THC and CBD and the Company is planning to evaluate the safety and pharmacokinetics (dose profile of the drug in the blood) of two of its oral capsule formulations in a Phase 1 clinical study. It will be the first study in a series of studies aimed at developing a product for the treatment of pain and spasticity in Multiple Sclerosis patients.
IV. Agro-Medical business
MMJ’s subsidiary United Greeneries will shortly become an MMPR (Marijuana for Medical Purposes Regulation) Licensed Producer in Canada, commercially producing cannabis in its Duncan facility to sell to registered patients.
Once licensed the Company can grow and supply advanced strains of medical grade cannabis for sale to the global regulated markets. Through the growing operation the Company will also develop cannabis strains and genetics with unique characteristics that make them suited to the treatment of different types of medical conditions.
The partnership with Yissum Research Development Company of the Hebrew University (Yissum) is a key driver for R&D innovation and business growth.
Yissum has over 8,000 patents, more than 700 technology licences, and over 80 companies have been spun out from its research work. Products based on its technologies have generated over US$2 billion in sales and earned it a reputation as one of the world’s leading research and development and technology transfer companies.
Oral capsule formulation
The Company is implementing Yissum’s innovative nanoparticle formulation in its oral capsules, which contain the active cannabinoids THC and CBD for the treatment of Multiple Sclerosis.
The proprietary formulation is expected to overcome the effects of the ‘first pass’ metabolic effect of the cannabinoids in the gastrointestinal tract leading to significantly enhanced bioavailability of cannabinoids, addressing the currently inherent problem of very low bioavailability of cannabinoids when administered orally.
The product is anticipated to allow ease of administration, no side effects as ulcerations and pain, no adverse taste together with the high bioavailability capacity low cost and long room temperature shelf life.
Inner cheek Buccal patch
The company is developing, together with the Hebrew University team, a flexible, muco-adhesive inner cheek patch, which comprises of active cannabinoid ingredients. The patch will potentially provide continuous delivery of THC and CBD for 4-6 hours. The ingredients are transferred through the mucous membrane in the cheek directly into the systemic blood circulation avoiding the digestive system. The product is anticipated to allow for better dose control, easy application, no adverse taste and cost effectiveness.