The profound therapeutic benefits attributed to cannabinoids seem to predominately come from non-psychoactive cannabidiol (CBD). CBD is accordingly the cannabinoid of major interest to ANANDA Scientific.
CBD is well suited as a human therapeutic since its use does not hamper every day activities like work, school, sports or driving a motor vehicle. CBD has no known undesirable side effects. ANANDA Scientific is further validating its nontoxic nature with what may be the first formally-sanctioned human clinical studies on safety. This is being done at a renowned hospital in Israel.
CBD can be obtained from marijuana, but it is particularly abundant in hemp. Hemp is a plant with no psychoactive properties, thus no abuse potential.
Preclinical studies suggest significant differences in functional performance between synthetic CBD and the natural CBD from plants. Natural CBD appears to be more potent. This enhancement could be driven by trace levels of other natural cannabinoids along with non-cannabinoid plant chemistry, a phenomenon called the “entourage effect”. However, there are other possible explanations for this phenomenon. Besides its apparently elevated potency, natural CBD is less costly to produce using conventional methods than is its synthetic counterpart. Furthermore, ANANDA Scientific has been developing its own novel, patentable technologies for purifying natural CBD that may greatly reduce production costs and times.
ANADA Scientific’s decision to concentrate on natural CBD is designed to combine the cost-effectiveness of purifying natural molecules with the potential therapeutic advantages embodied in the entourage effect or other means of augmentation.
One reason CBD has not been effectively used as a therapeutic is that it needs to be packaged as a cost-effective pill or capsule which can deliver more than just miniscule amounts into the bloodstream. CBD has inherently-poor oral bioavailability. Very little CBD is delivered into the bloodstream when it is taken by mouth, and this inefficiency has been a major impediment to making reliable therapeutic preparations. The disappointing results obtained during the few previous human clinical studies on CBD may be explained by this poor oral bioavailability.
The team at ANANDA Scientific believes that it has eminently resolved the oral bioavailability problem. ANANDA’s novel patented approach (ANANDA Particulate Technology™) has the unique ability to get substantive amounts of CBD, and other cannabinoids if and when desired, into the bloodstream through oral administration. It sets the stage for making cost-effective and reliable, non-psychoactive cannabinoid therapeutics for the first time.
ANANDA Scientific has placed its research, development and production assets wherever most advantageous. The Company’s R&D is in Israel, the global center for cannabinoid research, with certain scientific and medical activities advantageously situated in the USA, the largest therapeutics market in the world. Production is distinctively located in China, the world’s largest hemp producer and a huge potential market for CBD therapeutics.
Israel is especially noteworthy since the Israeli government is actively promoting the research needed to make cannabinoids bona fide medicine. Critical patents on cannabinoid use are consequently Israeli in origin, and these patents have been licensed to the Company. ANANDA Scientific has been moving forward there with sanctioned human trials of CBD. Importantly, these are of a sort readily acceptable to the U.S. Food and Drug Administration as well as regulatory authorities elsewhere.
Most people selling cannabinoids do not understand or refuse to accept how the “rescheduling” of these by the Federal government in the near future will work. They incorrectly expect to sell cannabinoids in an unrestricted fashion. It is instead unquestionable that the regulatory requirements for these after rescheduling will be like what exists for other drugs – with governmental authorities other than just the Drug Enforcement Agency finally empowered to become involved in a bureaucratic process that must be satisfactorily completed prior to any sales. Members of the Company are well experienced in dealing such matters in the United States and elsewhere.
As bona fide human medicine, products with CBD or other cannabinoids will have to be appropriately scrutinized by the Food and Drug Administration (FDA) to ensure safety and effectiveness. ANANDA Scientific has been distinctively preparing for this via properly-authorized clinical trials in Israel, and is thus is positioned well ahead of potential competitors. From an FDA perspective, the Israel work can be combined with work done in the United States once this become permissible. Considerable savings of time (and money) is a consequence.
For functional foods and nutraceuticals, ANANDA Scientific’s products will conform to the FDA’s Dietary Supplement and Health Education Act of 1994. Good Manufacturing Practices, which have rarely or never yet been done for cannabinoids, will be followed. No claims to treat a disease or an adverse health condition can be made for CBD-containing functional foods and nutraceuticals. Marketing for these will instead center about healthful or therapeutic benefits in a more general sense. Nevertheless, to enhance demand, information on efficacies realized in human clinical work done overseas with the same or similar products will be judiciously disseminated by the Company.
There is rapidly growing global demand for CBD as a nutraceutical or in functional foods, and no regulatory approvals are currently needed to sell it for these purposes. Demand already exceeds the existing supply, and the few CBD products available from other producers are of substandard purity and potency. ANANDA Scientific is commencing large-scale production of standardized CBD products in China, where hemp can be grown in the quantities needed to produce considerable amounts of CBD. The Company also has proprietary high-CBD plant strains in place there. Apropos of these advances, Ananda Scientific is confident that it will become a major global source for CBD in 2016.
Diabetes and chronic pain are huge public health problems. With patients numbering in the hundreds of millions, these conditions represent profitable, high-growth first markets for ANANDA Scientific’s pharmaceutical-grade CBD coupled with ANANDA Particulate Technology™. In China alone, the number of diabetics exceeds 114 million, and more than 100 million people are now living with chronic pain. In other words, the potential market in China for CBD as medicine is immense.
Diabetes is a global public health nightmare. About 371 million people now suffer from it, and 550 million diabetics are expected by 2030. There are approximately 30 million diabetics in North America, 60 million in Europe and 114 million in China.
Unlike insulin and other existing medications for diabetes, CBD may actually suppress, reverse and even cure the disease – and ANANDA Scientific owns relevant intellectual property for this indication.
China has one-third of all diabetics globally which makes China the largest market for diabetes medicine. Treating diabetes is literally bankrupting China’s healthcare system, so ways to reverse or even cure the disease are urgently needed. The Company is pursuing CBD-extract therapeutics in China with
“fast track” approval by the State Food and Drug Administration (SFDA). According to SFDA guidelines “Fast-track” means an expedited time to market, potentially under 2 years. Members of ANANDA Scientific’s management team have years of relevant professional experience in China..
There is a tremendous unmet need for medicines to treat chronic intractable pain. In particular safe, non-addictive therapeutics are needed to supplant opioids, which kill up to 250,000 people each year worldwide due to overdosing. CBD has potential as a non-addictive and otherwise safe pain management alternative for complementing or even replacing opioids.
Chronic intractable pain afflicts 249 million people in the Americas, Europe, Japan and India. In 2011, the market for appropriate medicines exceeded $20 billion in the United States and $50 billion worldwide. A non-addictive, safe and effective pain-relieving CBD product would be welcome everywhere and, in particular, by the 100 million Chinese chronic pain patients who remain woefully undertreated due to China’s historical fear of opioid addiction.