Corporate
The reasons why Cannabis Science™ is entering the pharmaceutical cannabis industry. Recent advances in science have opened the door to develop, produce, and commercialize, a variety of effective whole plant cannabinoid based pharmaceutical products with a wide variety of important applications.
Although cannabis has been used medicinally for thousands of years, until very recently little was known about how it actually worked. Some uses of cannabis are well known, such as alleviating nausea and stimulating the appetite for people with AIDS and cancer.
Other well-known uses include chronic pain, and reducing muscle spasms associated with neuromuscular disorders like MS and spinal cord injuries. Some current uses are poorly understood, such as its effectiveness in alleviating certain autoimmune disorders such a Crohn's Disease.
Our team of scientists will develop more effective ways to produce and commercialize the production of whole plant cannabinoid based pharmaceutical products. Even today new uses for cannabis are being found, such as the recent discovery that topical cannabis preparations can be effective against MRSI, the deadly antibiotic-resistant flesh-eating disease. Other topical applications, which are largely non-psychoactive, would target localized pain, such as arthritis, and burns, but also neuropathic pain, for which there are few effective treatments.
In 2001, an article published in the Canadian Medical Association Journal revealed that, based on self-identified needs, an estimated 2% (or 400,000) Canadian adults were already using cannabis for medical purposes. That number would extrapolate into roughly 4 million in the US. Consequently, we believe that it would not be unreasonable to think that the global medical cannabis market will potentially reach several billion dollars.
Whole Cannabis Pharmaceutical Products on the Market Today
GW has entered into agreement with the German pharmaceutical firm Bayer Healthcare for marketing Sativex® in the UK. This agreement provided GW with millions of dollars in licensing fees and operating capital.
In February of last year, GW Pharmaceuticals sold the rights to develop and market Sativex® for cancer pain in the US to Japanese firm Otsuka Pharmaceutical. Otsuka paid GW a signature fee of $18 million, and may pay up to $273 million in royalties and fees. In addition, Otsuka will bear the costs of all US development activities for Sativex® in the treatment of cancer pain, additional indications, and future formulations. GW and Otsuka will jointly oversee all US clinical development and regulatory activities.
Clearly, Otsuka's willingness to contemplate paying up to a quarter of a billion dollars in royalties and fees for one cannabis-based pharmaceutical with a less than overwhelming efficacy profile indicates that the total market for medical cannabis products is a multi-billion prospect. According to Investec Securities, GW's broker, Sativex® could have peak annual sales of $390m.
Also, in 2005 GW and the Spanish pharmaceutical company Almirall Prodesfarma, S.A. ("Almirall") announced that they had entered into an exclusive agreement for Almirall to market Sativex® in Europe (excluding the UK) Almiral paid GW a "$12 million signature fee." (approx $20 million at present exchange rates.)
Products Overview
Products
Our product, broadly described, is medical cannabis - a term which encompasses a wide variety of products, ranging from plants grown by patients for their own use to pharmaceutical products developed from one or more of the cannabinoid compounds found in the whole cannabis plant.
Cannabinoids are a group of terpenophenolic compounds present in Cannabis (Cannabis sativa L). Currently, 538 natural compounds were identified from this plant. 43 of these 108 are identified as cannabinoids, which are C21 compounds uniquely present in Cannabis sativa L. There are ten main types of cannabinoids and fourteen different cannabinoid subtypes. Tetrahydrocannabinol (THC) is the principal psychoactive ingredient in cannabis, but it also has other effects. Cannabidiol (CBD) and cannabinol (CBN) are the other two most prevalent natural cannabinoids and have received the most study. All three are listed as ingredients in Sativex®, the only multi-cannabinoid medicine currently approved for marketing (only in Canada.)
Cannabinoids were first discovered in the 1940s, when CBD and CBN were identified. THC was not identified until 1964, but by that time cannabis had been removed from the pharmacopeiae of most countries, making further research on the plant difficult.
There are three general types of cannabinoids:
1Phytocannabinoids occur uniquely in the cannabis plant.
2Endogenous cannabinoids are produced in the bodies of humans and other animals.
3Synthetic cannabinoids are similar compounds produced in a laboratory. Forms of synthetic THC are available by prescription in a number of countries, including the US. In the US, synthetic THC is marketed as Marinol®.
Phytocannabinoids, also called natural cannabinoids, herbal cannabinoids, and classical cannabinoids, are only known to occur naturally in significant quantity in the cannabis plant. They are concentrated in a viscous resin that is produced in glandular structures known as trichomes, and are most prevalent in the flowers of the female plants.
Cannabinoid receptors in the human body were not discovered until 1990. CB1 receptors are found primarily in the brain, specifically in the basal ganglia and in the limbic system, including the hippocampus. They are also found in the cerebellum and in both male and female reproductive systems.
CB1 receptors appear to be responsible for the euphoric and anti-convulsive effects of cannabis.
Cannabinoid pharmaceuticals, unlike many other pharmaceutical compounds, do not represent a risk factor for respiratory or cardiovascular failure. Cannabis has been called one of the safest drugs known by Federal Judge Young in 1977. In fact, there is no known lethal dose of cannabis. It has an estimated therapeutic index of 40,000 to one as compared to aspirin with a therapeutic index of 15.
CB2 receptors are found almost exclusively in the immune system, with the greatest density in the spleen. CB2 receptors appear to be responsible for the anti-inflammatory and possibly other therapeutic effects of cannabis.
The endocannabinoid system refers to a group of neuromodulators and receptors involved in a variety of physiological processes including appetite, pain sensation, mood, and memory. The system is named for endocannabinoids, the endogenous lipids that bind cannabinoid receptors (the same receptors that mediate the psychoactive effects of cannabis).
Science increasingly recognizes the role that endo-cannabinoids play in almost every major life function in the human body. Cannabinoids act as a bio regulatory mechanism for most life processes, which explains why medical cannabis has been recommended as a treatment for many diseases and ailments in anecdotal reports and scientific literature. Some of these ailments include: Pain, arthritic conditions, migraine headaches, anxiety, epileptic seizures, insomnia, loss of appetite, GERD (chronic heartburn), nausea, glaucoma, AIDS wasting syndrome, depression, bipolar disorder (particularly depression-manic-normal), multiple sclerosis, menstrual cramps, Parkinson's, trigeminal neuralgia (tic douloureux), high blood pressure, irritable bowel syndrome, and bladder incontinence.
Cannabis has been used medicinally for thousands of years in China, India and the Middle East. Of course, most traditional medicines were plant-based, but until recently no one knew how or why they worked. Modern science now routinely verifies the efficacy of this "folk medicine" tradition and the door is opening to a more systematic and effective use of cannabinoid therapies.
While cannabis was widely used in the West during the 19th century, the technology was lacking to detect and understand its active ingredients, to standardize dosages of those ingredients, and to effectively deliver those ingredients, owing largely to cannabis's non-water-solubility. Consequently, it became less widely used in the early 20th century and was eventually renamed "marijuana" and banned as part of a politically-driven prohibition craze. It was gradually removed from the pharmacopeiae of most advanced countries; research was discouraged, and when beneficial results were discovered, the studies were sometimes suppressed.
For example, when Senator Edward Kennedy (D-MA) was recently diagnosed with a form of brain cancer, malignant glioma, the media largely ignored reports from the medical cannabis community of studies showing that cannabinoids can kill glioma cancer cells.
Nearly a decade ago, the National Organization for the Reform of Marijuana Laws' weekly news release for December 31, 1998 reported that "Cell studies performed by researchers at Madrid's Universidad Complutense demonstrate that THC, one of the active compounds in marijuana, can induce cell death in certain brain tumor cells without affecting the surrounding healthy cells."
Dr. Franjo Grotenhermen of the German-based Association for Cannabis as Medicine (ACM) proposed that marijuana's constituents may one day play a role in cancer treatment. "It is desirable to have a substance that induces programmed cell death in tumor cells but not in health cells for the treatment of cancer," he wrote in the December 13 issue of the ACM-Bulletin. "It has been demonstrated by the Spanish scientists ... that THC could be such a substance."
Board of Directors
Corporate
Dr. Robert J. Melamede, Ph.D. President & CEO
Dr. Melamede has a Ph.D. in Molecular Biology and Biochemistry from the City University of New York. He retired as Chairman of the Biology Department at University of Colorado, Colorado Springs in 2005, where he continues to teach. Dr. Melamede is recognized as a leading authority on the therapeutic uses of cannabis, and has authored or co-authored dozens of papers on a wide variety of scientific subjects. Dr. Melamede also serves on the Advisory Board of The Journal of the International Association for Cannabis as Medicine, and the Scientific Advisory Board Medical of the Marijuana Policy Advocacy Project, as well as the Scientific Advisory Board of Americans for Safe Access. He also served as a director of Newellink Inc, a Colorado-based company specializing in cancer research.
Richard Cowan Director, Chief Financial Officer
Mr. Cowan has a BA from Yale University in Economics and extensive experience in corporate finance. Prior to his commitment to cannabis activism, Cowan served on the boards of several publicly owned companies, and has extensive experience in corporate finance. Cowan is a former CEO of the National Organization for the Reform of Marijuana Laws, and for the last ten years has published MarijuanaNews.com.
Cannabis Science's corporate leadership team brings together decades of relevant experience and knowledge in the relevant scientific, financial, regulatory and political subjects. If this were all that the management team brought to the table, the company would be well-positioned for success. However, the team also operates on an ethos rooted in the medical cannabis community – a dedication to bringing the safest, most effective medicines possible to the patients who need them.
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