The following information may contain forward-looking statements that reflect GWs current expectations regarding future events. Actual events could differ materially from those projected herein. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s recent filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements. GW undertakes no obligation to update or revise this information, whether as a result of new information, future events or circumstances or otherwise. Sativex® and Epidiolex® are registered trademarks of GW Pharmaceuticals.
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 29 countries outside the United States. GW is advancing an orphan drug program in the field of epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and expects to commence a Phase 3 program in Infantile Spasms. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.
The cannabis plant is the unique source of more than 70 structurally-related, plant-derived cannabinoids. Although one cannabinoid, THC, is known to cause psychoactive effects associated with the use of illicit herbal cannabis, none of the other cannabinoids is known to cause intoxication. In recent decades, there have been major scientific advances that have led to the discovery of new plant-derived cannabinoids and a cannabinoid receptor system in the human body, or endocannabinoidsystem.
GW’s research to date has focused on the following plant-based cannabinoids:
THC (Delta-9 Tetrahydrocannabinol)
D8-THC (Delta-8 Tetrahydrocannabinol)
CBD (Cannabidiol)CBN (Cannabinol)
GW also has the ability to evaluate the therapeutic potential of single cannabinoids, as well as combinations of cannabinoids. GW is currently evaluating the potential for cannabinoids in the treatment of Type 2 diabetes, ulcerative colitis, CNS disorders, including epilepsy and schizophrenia, cancer and neurodegenerative disease.
- Early-onset, treatment-resistant epilepsy
- Autism Spectrum Disorders
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)
- Cerebral Palsy in Children
The prospect for cannabinoid therapeutics to be approved through the FDA approval pathway has been the subject of statements from the White House, the Senate (International Caucus on Narcotics Control) and the Drug Enforcement Administration, or DEA.
The White House Office of National Drug Control Policy states on its ‘‘Facts and Answers to the Frequently Asked Questions about Marijuana’’ on the White House website that the FDA has recognized and approved the medicinal use of isolated components of the cannabis plant and related synthetic compounds, and it specifically references Sativex as a product that is currently in late-stage clinical trials with the FDA. See http://www.whitehouse.gov/ondcp/frequently-asked-questions-and-facts-about-marijuana
In its June 2012 report entitled ‘‘Reducing the U.S. Demand for Illegal Drugs,’’, the U.S. Senate Caucus on International Narcotics Control expresses the view that the development of cannabis-based therapeutics through an approved FDA process is the best route to explore and references Sativex as a promising product currently in the final phase of the FDA’s trials for approved use in the United States. In that report, the Senate Caucus urged the FDA to complete a careful review of Sativex in a timely manner. See http://www.feinstein.senate.gov/public/index.cfm/files/serve/?File_id=81b53476-64a3-4088-9bae-254a84b95ddb
In its January 2013 report entitled ‘‘The DEA Position on Marijuana’’, the DEA expresses support for ongoing research into potential medicinal uses of cannabis’s active ingredients, and specifically references Sativex. See http://www.justice.gov/dea/docs/marijuana_position_2011.pdf
GW cultivates plant material in order to extract the cannabinoids and other pharmacologically-active components from the plant. The extract is then formulated and incorporated into appropriate dosage forms. Each step is carefully quality-controlled and subject to the same strict Standard Operating (SOPs) Procedures, and international Current Good Manufacturing Practice (CGMP) regulations that all drug manufacturers must adhere to. Compliance to these standards and regulations is carefully monitored by national regulatory agencies, such as the FDA. GW utilizes the cannabis plant material solely to develop its cannabinoid pharmaceutical products. GW does not provide herbal cannabis to outside researchers.
GW's cannabis plants are grown under computer-controlled conditions in secure glasshouses at an undisclosed location in the UK. GW has developed a highly sophisticated cultivation process to ensure plant material grown is of sufficient quality and consistency to be suitable for incorporation into pharmaceutical products. Strict Standard Operating Procedures are followed to ensure non-contamination by chemicals, infestation or fungal growth, consistency of content, methods of harvest, drying, primary extraction, storage and onward consignment. Temperature, humidity, total light and photoperiod are all controlled by computer.
The absolute requirement for a plant-based medicine from a regulatory point of view is "control of starting materials". A drug in its manufacture goes through many processes, each of which needs to be monitored and strict quality controls applied. This process and quality control would be invalidated if the starting materials (i.e. the herbal materials) were of poor or inconsistent quality. Laboratory analysis of GW’s selected plant lines demonstrates that the cannabinoid ratios are very consistent. Such high levels of consistency are unusual in plants and are very important in new drug approval applications made to regulatory authorities, such as the FDA.
GW's foremost consideration therefore is the cultivation of highly consistent plants with defined cannabinoid ratios. Total yield of one or other cannabinoid is relatively less important than consistency. We have a number of chemovars (plant varieties characterized by their chemical content) chosen for their composition and morphological traits i.e. hybrid vigour and disease resistance. GW does not distribute herbal cannabis to outside researchers or institutions.
GW is responsible for the manufacture and supply of its products for commercial and clinical trial purposes. GW operates under Current Good Manufacturing Practice manufacturing licenses issued by the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom and the company’s facilities have been audited by the MHRA on several occasions. GW’s personnel have extensive experience in production of botanical raw material (BRM), pharmaceutical production, quality control, quality assurance and supply chain. For commercial Sativex production, the BRM production is currently contracted to an external third party; however GW staff is at the contract site to monitor activity and production quality on a weekly basis. All other steps in the commercial production process for Sativex are performed in-house.