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 filings with the U.S. Securities and Exchange Commission, including the recent prospectus that was filed with the Securities and Exchange Commission in January, 2014. 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.
Who is GW Pharmaceuticals?
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel medications from proprietary cannabinoid formulations in a broad range of disease areas. In its 15 years of operations, GW has established the world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, its intellectual property portfolio and its regulatory and manufacturing expertise. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex, which has to date been approved for the treatment of spasticity due to multiple sclerosis in 25 countries. Sativex is also in Phase3 clinical development as a potential treatment of pain in people with advanced cancer. The cancer pain indication represents the initial target indication for Sativex in the United States. GW also has opened an IND with FDA for Phase 3 clinical development as a potential treatment of spasticity due to multiple sclerosis. In addition to Sativex, GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received Orphan Drug Designation from the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, each of which are severe infantile-onset, genetic, drug-resistant epilepsy syndromes. GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type‑2 diabetes, and schizophrenia.
What are cannabinoids?
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.
How do cannabinoids work?
Only in the last two decades, a natural cannabinoid receptor system has been discovered in the human body. It is by interacting with these receptors that cannabinoids exert many of their pharmacological effects. The discovery of the cannabinoid receptor system has sparked renewed interest in the therapeutic potential of cannabinoids by providing important new targets for drugs. There are at least two types of cannabinoid receptors in mammalian tissues, CB1 and CB2. CB1 receptors are present in the brain and spinal cord and in certain peripheral tissues. CB2 receptors are expressed primarily in immune tissues. There is preliminary evidence to suggest that additional cannabinoid receptor types may exist. The cannabinoid system also interacts with many other neurotransmitter/neuromodulator systems, such that cannabinoids affect almost every bodily system.
What is Epidiolex®?
Epidiolex is GW’s proprietary product candidate that contains a liquid formulation of highly purified plant-derived cannabidiol (CBD) as its active ingredient in development as a treatment for various orphan pediatric epilepsy syndromes. Epidiolex has been granted Orphan Drug Designation by the FDA in the treatment of Dravet and Lennox-Gastaut syndromes, each of which are severe infantile-onset, drug-resistant epilepsy syndromes. The FDA has granted expanded access INDs to several independent investigators in the U.S. to allow treatment of pediatric epilepsy patients with Epidiolex. These patients suffer from Dravet syndrome, Lennox-Gastaut, and other pediatric epilepsy syndromes.
With advice from pediatric epilepsy specialists, GW has proposed an investigational plan to the FDA and intends to submit an IND to the FDA and commence clinical development in the second half of 2014.
What is Sativex?
GW’s lead product, Sativex, is an oral spray which consists of a formulated extract of the cannabis sativa plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol, or THC, and cannabidiol, or CBD, as well as other minor cannabinoids and other active non-cannabinoid plant components. In order to achieve a fully standardized formulation of these complex extracts, GW employs a range of advanced analytical technologies to demonstrate batch-to-batch uniformity. As a result of these technologies, GW is able to standardize the formulation across the extracts as a whole, not simply by reference to their key active components.
What other medical indications and/or cannabinoid formulations is GW studying?
GW’s research to date has focused on the following plant-based cannabinoids:
THC (Delta-9 Tetrahydrocannabinol) CBDVA (Cannabidivarin—Acid)
D8-THC (Delta-8 Tetrahydrocannabinol) CBC (Cannabichromene)
THCA (Tetrahydrocannabinol—Acid) CBG (Cannabigerol)
THCV (Tetrahydrocannabivarin) CBGA (Cannabigerol—Acid)
THCVA (Tetrahydrocannabivarin—Acid) CBGV (Cannabigerovarin)
CBD (Cannabidiol) CBN (Cannabinol)
CBDA (Cannabidiol—Acid) CBNV (Cannabinovarin)
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.
What is GW’s intellectual property position?
GW has an extensive intellectual property portfolio, which includes multiple patent families with issued and/or pending claims directed to plants, plant extracts, extraction technology, pharmaceutical formulations, drug delivery and the therapeutic uses of cannabinoids, as well as plant variety rights, know-how and trade secrets.
How is Sativex administered?
Sativex is administered as an oral spray, whereby the active ingredients are absorbed in the lining of the mouth, either under the tongue or inside the cheek. This route of administration is intended to achieve a reliable rate of absorption and high level of bioavailability of THC and CBD. The spray cannot be inhaled due to the particle size. The spray provides patients with the flexibility to self-manage their dosage in order to achieve and maintain an optimal therapeutic response. In the U.S., the FDA has required the spray to be incorporated within additional packaging which includes a dose counter in order to reduce the potential for diversion. There has been no evidence of abuse or diversion in the markets where Sativex has been available by prescription.
What is the reason for Sativex being administered using a spray dosage form?
In the treatment of conditions being targeted by Sativex, patients need to be able to individualize or adjust their dose. The spray formulation provides a reliable and steady absorption of the active ingredients with the necessary dosing flexibility to achieve optimal risk-benefit.
GW does not believe that an oral (swallowed) or inhaled formulation is optimal in administering a cannabinoid formulation containing THC.
Why does Sativex contain both CBD and THC?
Initial academic research in the field of cannabinoid science focused almost exclusively on THC. It has been widely published in scientific literature that THC has pain suppression, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant and anti-nausea properties. GW’s research and development, however, has focused primarily on exploring cannabinoids other than THC and identifying potential therapeutic applications of these other cannabinoids. That research has focused particularly on CBD, which has shown in pre-clinical testing conducted by the company and supported by publications in scientific literature to have anti-inflammatory, anti-convulsant, anti-psychotic, anti-oxidant, neuroprotective and immunomodulatory effects. In addition, CBD does not appear to be intoxicating, as evidenced by its distinct pharmacology from THC as well as evidence from clinical trials. Furthermore, publications in scientific literature research suggest that the presence of CBD may mitigate some of the side-effects of THC.
Why did GW choose spasticity in multiple sclerosis (MS) as its first primary indication for Sativex in the U.K. and Europe?
Sativex offers the prospect of treating a significant unmet need in patients with MS who suffer from spasticity, a symptom of MS characterized by muscle stiffness and uncontrollable spasms. According to the World Health Organization, MS affects 1.3 million people worldwide, of which over 400,000 are in the United States and over 600,000 are in Europe. Approximately 80% of these patients suffer from spasticity. Some of the features of spasticity include muscle stiffness, difficulty straightening joints, reduced mobility, limb weakness, shaking, intermittent spasms and pain. As a result, ‘‘simple,’’ everyday movements become difficult or impossible altogether. In addition, painful muscle spasms can lead to difficulty with sleeping, sitting in a chair or lying in bed. Moderate to severe spasticity can lead to significant impairment. There is no cure for spasticity, and it is widely recognized that currently available oral treatments afford only partial relief and have unpleasant side effects. Sativex offers the prospect of treating patients who have failed existing oral therapies and who might otherwise require invasive and costly alternative treatment options.
In which countries is Sativex currently approved for spasticity in MS?
Sativex is approved as a treatment for MS spasticity in 25 countries and is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with approvals or recommendations for approval in an additional 12 European countries, as well as Australia, New Zealand and Kuwait.GW anticipates commercial launches in the majority of these countries in the next 12 months. One additional country has recommended approval for Sativex (Ireland), and regulatory submissions are under review in 9 other countries (Bahrain, Egypt, Malaysia, Morocco, Oman, Qatar, Saudi Arabia, South Africa, United Arab Emirates). GW also intends to continue to seek and obtain approvals in other countries.
With which other pharmaceutical companies is GW collaborating or to which it has licensed the marketing rights to Sativex?
GW has entered into collaborations for Sativex with the following major pharmaceutical companies: Otsuka in the United States; Almirall S.A. in Europe (excluding the United Kingdom) and Mexico; Novartis Pharma AG in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel) and Africa; Bayer HealthCare AG in the United Kingdom and Canada; Neopharm Group in Israel; and Ipsen in Latin America (excluding Mexico and the Islands of the Caribbean. These agreements provide our collaborators with the sole right to commercialize Sativex in their territories for all medical indications.
For which medical conditions is GW developing Sativex in the U.S.?
GW currently has two active Phase 3 programs with the U.S. Food and Drug Administration (FDA):
1) GW is evaluating Sativex in a Phase 3 program to treat persistent pain in people with advanced cancer who experience inadequate pain relief despite the use of optimized chronic opioid therapy. This Phase 3 program, involving over 1,000 patients, represents the lead target indication for Sativex in the United States and is based on positive data from two Phase 2 trials of Sativex involving over 530 patients in this indication.
2) GW has recently opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of spasticity due to Multiple Sclerosis (MS). Under the terms of GW’s agreement with Otsuka, Otsuka is responsible for wholly funding both Phase 3 clinical programs.
Why is GW studying cancer pain in the U.S., rather than MS spasticity?
GW intends on studying both cancer pain and MS spasticity indications in the U.S. with the objective of supporting New Drug Applications (NDA) with FDA for Sativex in both indications, and, for cancer pain, with regulatory authorities around the world. GW believes that Sativex has the potential to address significant unmet need in the U.S. by treating these initial indications.
When will the cancer pain trials be completed?
GW anticipates that initial Phase 3 top-line data will be available towards the end of 2014.
Does GW intend to seek FDA approval of Sativex for MS spasticity?
Yes, GW believes that MS spasticity represents an attractive indication for Sativex in the United States and intends to pursue an additional development program for this significant opportunity. GW anticipates that it will be required to conduct an additional clinical development program prior to the submission of a separate NDA with the FDA for this indication and has recently opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of spasticity due to Multiple Sclerosis (MS). We expect a Phase 3 trial to commence in the second half of 2014.
What do U.S. federal authorities think of Sativex and GW’s research programme?
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
What are the side effects of Sativex?
The safety profile of Sativex across placebo-controlled trials conducted in MS patients shows that the drug is generally well tolerated, with the most commonly occurring individual adverse events (occurring at a rate greater than 10%) being dizziness, fatigue and nausea. Adverse events were typically mild or moderate in severity and the pattern of common adverse events is similar in both short-term and long-term exposure to Sativex. The most common adverse events tend not to be recurrent, occurring in the first four weeks of treatment and much less commonly thereafter. In two Phase 2 cancer pain studies, the most commons side effects were somnolence, dizziness and nausea.
Do patients become “high” when they take Sativex?
There is no evidence from Sativex clinical trials that patients obtain a high similar to that sought by recreational cannabis users. The oral spray method of delivery results in a slow rise in THC blood levels and also enables patients to adjust their dose. As a result, patients are typically able to separate the thresholds for symptom relief and intoxication, thus enabling them to obtain symptom relief without experiencing a high. Patients in GW’s trials have emphasized that they seek to obtain the medical benefits without intoxication. Furthermore, preclinical, pharmacological, and clinical studies with CBD suggest that CBD may mitigate the psychoactive effects of THC. All of GW’s non-Sativex cannabinoid research focuses on cannabinoid molecules other than THC. These other molecules are not psychoactive.
Is Sativex likely to be abused?
In contrast to smoking or vaporizing cannabis, the oral spray method of delivery employed by Sativex results in a slow rise in THC blood levels, which is intended to minimize any reinforcing effects. Furthermore, preclinical, pharmacological, and clinical studies with CBD suggest that CBD may mitigate the psychoactive effects of THC. A study published in the June 2011 issue of Human Psychopharmacology by Kerri Schoedel, et al. compared the abuse liability of Sativex at three dose levels (four sprays taken consecutively, eight sprays taken consecutively and 16 sprays taken consecutively) with placebo and two doses of dronabinol (synthetic THC) capsules (20mg and 40mg) in a randomized, double-blind, crossover study in 23 healthy subjects with a history of non-dependent but regular recreational cannabis use. The effects of Sativex dose for dose were generally lower than dronabinol, a Schedule III drug that is not abused. It should be noted that, in contrast to this abuse liability study in which Sativex sprays were administered all together, patients in the Phase 3 trials (and in prescriptive use outside the U.S.) administer between three and ten sprays over a 24-hour period.
There has been no evidence of abuse or diversion in the markets where Sativex has been available by prescription. In February 2013, the Advisory Council on the Misuse of Drugs, which is the advisory body to the U.K. government with respect to controlled substances, confirmed its recommendation to the U.K. government that it deems Sativex to have low abuse potential and low risk of diversion, and that Sativex thereafter should be scheduled as a Schedule 4 substance. In April, 2013, GW received confirmation from the U.K. Home Office that Sativex® had been rescheduled in the UK from Schedule 1 under the Misuse of Drugs Act to Schedule 4, part 1. The move follows a recommendation to the Home Office by the Advisory Council on Misuse of Drugs (ACMD), which determined that Sativex® has a low potential for abuse and low risk of diversion.
Does GW cultivate its own cannabis? What does GW do with the herbal material?
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.
How does GW grow cannabis?
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 facility is situated in the South of England but for clear security reasons GW does not divulge the precise location.
Why does GW cultivate its own cannabis plants?
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.
Who is responsible for manufacturing GW’s products?
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.
Has GW exported its products to other countries?
GW has successfully exported cannabinoid commercial or research materials to 34 countries and has the necessary in-house expertise to manage the import/export process worldwide. The company has substantial expertise in, and experience with, relevant international and national regulations in relation to the research, distribution and commercialization of cannabinoid medications. GW has formed relationships with relevant international and national agencies in order to enable licensing of research sites, establishing appropriate product distribution channels and securing licensed storage, obtaining import/export licenses, and facilitating amendments to relevant legislation if required prior to commercialization. GW does not provide herbal cannabis to outside researchers.
If Sativex is approved for use in the U.S., would GW look at establishing a cannabis cultivation facility there?
GW’s plants are grown at a secure facility in the South of England. The company has no current plans to establish a growing facility in the U.S. This situation is consistent with how opioids medications are manufactured. Pursuant to long-standing (85 years) international policies, there are certain countries that are designated to cultivate opium to provide the raw materials to produce prescription opioids. The U.S. imports that raw material (usually in the form of concentrate of poppy straw) and manufactures the finished products. The U.S. does not cultivate the opiate plant material.
While this policy may not, as a matter of international treaty obligations, be required for cannabis-derived products, it demonstrates that domestic (U.S.) cultivation of plant material would not be necessary for GW to research and develop finished pharmaceutical products in the U.S.
Why has GW chosen to derive Sativex from botanical cannabis rather than from synthetic cannabinoids (like Marinol)?
GW believes that the development of medications from plant-derived cannabinoid extracts offers the following important advantages including:
• Plant extract formulations may contain one or more principal cannabinoids offering a multi-action profile designed to address many of the causative factors of complex diseases.
• This approach is optimally suited to targeting the endocannabinoid system, the complexities of which make the ‘‘single-target’’ approach to development of cannabinoid therapeutics more challenging.
Accordingly, GW is developing a broad range of medications comprising different cannabinoid ratios, in accordance with international regulatory standards.
Are other companies developing cannabinoid medications?
Synthetic THC (dronabinol ) and nabilone (a synthetic molecule similar to THC) capsules have been approved and distributed in the United States for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic (nausea and vomiting) treatments. Dronabinol is also approved and distributed in the U.S. for anorexia associated with weight loss in patients with AIDS. There is exploratory research into the effects of THC formulations in other areas.
Some pharmaceutical companies are engaged in discovery research into synthetic agonists and antagonists of CB1 and CB2 receptors. Other companies supply synthetic cannabinoids and cannabis extracts to researchers for pre-clinical and clinical investigation.
The FDA is accustomed to reviewing new chemical entities (NCEs), i.e., medications that are composed of synthetic molecules. Will it be possible to secure FDA approval of a medication comprising a complex botanical extract?
In 2005, the FDA issued a guidance entitled “Guidance to Industry: Botanical Drug Products.” This guidance set forth the pathway that a pharmaceutical company must follow in order to develop a prescription medication that is derived from complex botanical materials. Since that time, FDA has approved two products pursuant to that pathway, and other botanically-derived products, such as Sativex, are in the research stage.
What effect has the U.S. Controlled Substances Act (CSA) and the Drug Enforcement Administration (DEA) had on the Sativex research program?
Controlled substances that are pharmaceutical products are subject to a high degree of regulation under the CSA, which establishes, among other things, certain registration (license), manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA. The DEA classifies controlled substances into five schedules: Schedule I, II, III, IV or V substances. Schedule I substances by definition have a high potential for abuse, no currently ‘‘accepted medical use’’ in the United States, lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the United States.
Because Sativex contains cannabis extracts, prior to any future FDA approval, it is classified under the CSA as a Schedule I substance. Therefore, each of GW’s research sites is required to submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that allowed these sites to handle and dispense Sativex and to obtain the product from GW’s importer. The current Phase 3 cancer pain program includes large numbers of U.S. research sites and although it was unusual for the DEA to be asked to license numerous sites to conduct research with a Schedule I substance, the agency did so after assessing each location and researcher, without any significant issues.
The importer for the clinical trials also was required to obtain a Schedule I importer registration and an import permit for each import. GW does not currently conduct any U.S. manufacturing or repackaging/relabeling of either Sativex or its active ingredients (i.e., the cannabis extract). Sativex is imported in its fully-finished, packaged and labeled dosage form.
Sativex is currently in Schedule I of the CSA. If the FDA approves Sativex, how can it be made available to patients?
While herbal cannabis is a Schedule I controlled substance, products containing cannabis extracts, once approved by the FDA for medical use, must be placed in Schedules II—V, since approval by the FDA satisfies the ‘‘accepted medical use’’ requirement. If and when Sativex receives FDA approval, the DEA, in consultation with FDA and the National Institute on Drug Abuse (NIDA), will make a scheduling determination and place it in a schedule other than Schedule I in order for it to be prescribed to patients in the United States. If approved by the FDA, GW expects the finished dosage form of Sativex to be listed by the DEA in Schedule II or III. In the UK, Sativex has been rescheduled from Schedule 1 under the Misuse of Drugs Act to Schedule 4.
When GW's cannabis-derived medications, such as Sativex, become approved for marketing in a country, does herbal cannabis also become legal for medical use?
No. The approval of Sativex in countries has not led to any changes in the legal status of herbal cannabis. In Germany and Australia, for example, the law was amended to permit the research and marketing of Sativex, but herbal cannabis remained illegal for recreational and medical use.
Is there a place for cannabis-derived medications like Sativex, when herbal cannabis is readily available in dispensaries in many states in the U.S.?
GW believes that patients wish to use, and deserve to have access to, a medicine that is legally prescribed, does not require smoking or some form of domestic preparation, is of guaranteed composition and quality, has been developed, fully characterized and approved by regulatory authorities for use in their specific medical condition and is dispensed by pharmacists under the supervision of their doctor.
Why has GW chosen to pursue approvals from regulatory agencies such as the FDA, rather than sell its products through cannabis dispensaries?
The national regulatory processes of the U.K., U.S., and other countries have been developed over the past century to protect patient health and safety. GW believes that all medicines should undergo these review and approval processes before they are made available to patients. Sativex, like other medications in development, undergoes extensive testing in preclinical and rigorous controlled clinical trials to examine its safety and efficacy. It is also manufactured according to internationally recognized Current Good Manufacturing Practice standards. We have generated a significant body of evidence relating to Sativex and thus its specific constituents.
GW believes that its programme demonstrates that it is possible to develop a cannabis-derived medication in accordance with modern medical criteria, and therefore, that this is the approach that should be taken, as is the case with all other medications prescribed for serious medical conditions.
Is GW supportive of state “medical marijuana” programmes and the use of herbal cannabis -- smoked or otherwise -- as medicine?
No. GW supports the evidence-based approach to developing new medications according to the FDA approval process. Sativex is standardized in composition, thoroughly tested and quality-assured, and administered in a controlled and defined dose in an appropriate manner. Sativex contains both THC and CBD, and both preclinical and clinical studies suggest that CBD may lessen many of the negative effects of THC, including intoxication. The Sativex clinical development program is designed to demonstrate that it is possible to develop a cannabis-derived medication in accordance with modern medical standards--such as those established by the FDA process--as is the case with all other medications prescribed for serious medical conditions. Products that have gone through the FDA process have demonstrated that they are safe and efficacious for a particular medical condition; that they have been manufactured in accordance with properly validated quality-control processes; that they are highly standardized and consistent batch-to-batch; and that they provide a fixed and reproducible dose; and that they may be reimbursed by the patient’s health care insurance program.