GW in General

When was GW established?
The Group was founded in early 1998 and was first granted licences by the Home Office in June 1998 to research and develop cannabinoid prescription medications.
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What is GW Pharmaceuticals?
GW Pharmaceuticals was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes.

GW is a pharmaceutical group developing a portfolio of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic conditions. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW maintains control over all aspects of the product development process - botanical research, cultivation, extraction, formulation into drug delivery technologies, clinical trials and regulatory affairs. The Group has a broad product portfolio and the Directors have identified certain key markets for its products including Multiple Sclerosis, neuropathic pain, and cancer Pain.

GW’s lead product, Sativex®, received regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis in April 2005. In August 2007, Health Canada approved Sativex® as adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Both approvals were secured under the Notice of Compliance with Conditions (NOC/c) policy. Sativex® is marketed in Canada exclusively by Bayer Healthcare.
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How many staff does GW have?
GW has approximately 120 employees.
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Where is GW located?
GW's head office is on the Porton Down Science Park near Salisbury in Wiltshire. The Group also has other offices in Cambridgeshire and London.
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What are the aims of GW Pharmaceuticals?
GW is a pharmaceutical company developing a portfolio of cannabinoid prescription medications to meet patient needs in a wide variety of indications around the world. In April 2005 Sativex® received regulatory approval from Health Canada for use as adjunctive therapy for the symptomatic relief of neuropathic pain in adults with multiple sclerosis. In August 2007, Health Canada approved Sativex® as adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Both approvals were secured under the Notice of Compliance with Conditions (NOC/c) policy. Sativex® is marketed in Canada exclusively by Bayer Healthcare.

GW's clinical research is initially focused on Multiple Sclerosis, cancer pain and neuropathic pain. The Company plans to continue to extend its research programme into new areas. In July 2007, GW and Otsuka Pharmaceutical Co., Ltd. announced that they had signed a global cannabinoid research collaboration in the fields of Central Nervous System (CNS) and oncology in order to research, develop and commercialize a range of candidate cannabinoid products.
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Does GW carry out research under special licences?
Yes. GW operates under licences granted by the UK Home Office under Section 7 of the Misuse of Drugs Act 1971. These licences allow the Group to research and develop cannabinoid prescription medications.
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Where does GW grow cannabis?
GW's cannabis plants are grown under computer-controlled conditions in secure glasshouses at a secret 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 (SOPs) 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 we do not divulge the precise location.
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Cannabinoids and Cannabis-Derived Medications

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 need to be monitored and strict quality controls applied. This process control and QC would be invalidated if the starting materials (i.e. the herbal materials) were of poor or inconsistent quality. Laboratory analysis of GW’s selected chemovar lines demonstrates that the cannabinoid ratios are very consistent. Such high levels of consistency are unusual in plants and are very important in applications made to medical regulatory authorities.

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 (varieties characterised by their chemical content) chosen for their composition and morphological traits i.e. hybrid vigour and disease resistance.

GW cultivates cannabis in order to be able to control the starting materials for the in-house production of GW’s cannabinoid pharmaceutical products. GW does not distribute herbal cannabis to outside researchers or institutions.
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What does GW do with the herbal material?
Once the plants have matured, they are harvested and dried. GW then extracts the cannabinoids and other pharmacologically-active components from the aerial parts of the plant.

By extraction we arrive at a pharmaceutical grade material and from there we can than proceed to formulation work and continue to incorporate those materials in the appropriate drug delivery modalities. Each step is carefully quality-controlled and subject to strict Standard Operating Procedures, as well as international Good Manufacturing Practice standards.
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What are cannabinoids?
Cannabinoids are a group of molecules found only in the cannabis plant. Different cannabinoids appear to have different pharmacological effects. Certain cannabinoids have been shown to have analgesic, anti-spasmodic, anti-convulsant, anti-tremor, anti-psychotic, anti-inflammatory, anti-oxidant, anti-emetic and appetite-stimulant properties.
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How does GW produce its cannabinoid medications?
GW's cannabinoid medications are derived from standardised extracts of proprietary cannabis plant varieties bred to exhibit a pre-determined content of cannabinoids. These extracts are incorporated into pharmaceutically-appropriate drug delivery technologies and then undergo pre-clinical and clinical testing prior to submitting applications to national regulatory authorities.
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Why not just let patients smoke cannabis?
In GW's opinion, smoking is not an acceptable means of delivery for a medicine. We believe that patients wish to use a medicine that is legally prescribed, does not require smoking, is of guaranteed quality, has been developed and approved by regulatory authorities for use in their specific medical condition and is dispensed by pharmacists under the supervision of their doctor.

The national regulatory processes of the UK, US, 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 rigorous controlled clinical trials to examine its safety and efficacy.

We believe our program demonstrates that it is possible to develop a cannabis-derived medication in accordance with modern medical criteria, and therefore, that is the approach that should be taken, as is the case with all other medications prescribed for serious medical conditions.
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How are these cannabinoid medications administered to patients?
GW's first product, Sativex®, is administered as a measured dose oral (oro-mucosal) spray that is absorbed by the lining of the patient’s mouth This method of administration enables patients to titrate (adjust) their dose to achieve symptom relief without incurring an unacceptable degree of side effects.
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Do patients get high when using GW’s cannabinoid medications?
By careful self-titration (dose adjustment), most patients are able to separate the thresholds for symptom relief and intoxication, the 'therapeutic window', so enabling them to obtain symptom relief without experiencing a 'high'. Patients emphasise that they seek to obtain the medical benefits without intoxication.
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Is GW researching other cannabinoids besides THC?
GW has conducted considerable research into CBD (cannabidiol), a non-psychoactive cannabinoid. CBD has anti-inflammatory, analgesic, anti-psychotic, anti-convulsant, and other properties. It is also believed to mitigate many of the side effects of THC. GW has also commenced a clinical development programme of its novel cannabinoid product, delta-9-tetrahydrocannabivarin (THCV). THCV has shown promise in pre-clinical studies as a potential treatment for obesity, diabetes and related metabolic disorders. A range of other cannabinoid molecules are undergoing early research evaluation.

GW is interested in researching as many of the cannabinoids as possible. We are also interested in some of the non-cannabinoid contents. There are some ingredients in cannabis that have very potent pharmacological activity but which are not cannabinoids.
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What research is required to obtain regulatory approvals for GW’s products?
GW's clinical trials programme, which is independent of Government funding, is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. GW's team is also supported by a number of prominent scientific advisers in this field in Europe and North America.

In general, each step that is taken to produce a pharmaceutical needs to be tested under a range of conditions including extremes to simulate error. The test methods themselves need to be validated across the range of values expected. A development programme for regulatory approval has three main objectives: QUALITY, SAFETY and EFFICACY.

QUALITY relates to consistency of the product throughout production and in its final presentation and packaging. This will also include long term testing of stability in order to establish an acceptable shelf life. The starting material will need to be tested for contaminants (which should be absent) such as pesticide and fungicide residues, fungal and microbial toxins, heavy metals, etc. Each test is performed many times.

SAFETY Regulatory authorities require evidence from controlled studies and in depth critical review of the literature by experts in order to assess safety. GW has embarked upon this costly and time consuming undertaking to be able to provide sufficient evidence of appropriate quality to satisfy the regulatory authorities. The safety of the drug in clinical usage is continually monitored throughout the entire clinical development programme as well as following regulatory approval.

EFFICACY Prior to submission of a dossier for regulatory approval there are three phases of clinical research:

Phase I.
These are studies generally in healthy volunteers where the safe dose range of the drug is established. Phase I programmes are typically run in dedicated clinical pharmacology departments which do nothing but early-phase safety studies. Subjects may be exposed to increasing doses of the drug whilst all bodily functions are closely observed and blood samples taken to assess blood levels of the drug. Sometimes subjects are asked to perform tasks (e.g. exercise) or, more appropriately for cannabis-based medicines, batteries of intensive cognitive and psychometric function testing. The data from these studies assists in establishing appropriate dosage schedules to be used in the Phase II studies.

Phase II.
These studies are generally carried out in small groups of patients. Usually specific aspects of the patients condition are studied to demonstrate the effect, if any, of the drug on defined endpoints and to establish a dose/response relationship if present. In these studies the clinical endpoints are validated for their use in larger studies (i.e. are we asking the right questions or doing the right test to best evaluate the therapeutic value of the drug under test). Some drugs which are seemingly similar may require very different measures of efficacy. We suspect cannabis may well be one that requires very close attention to the clinical endpoints.

Phase III.
Having established an acceptable dose range and validated the clinical endpoint in a range of conditions and having shown therapeutic benefit in the smaller Phase II studies then larger scale studies are undertaken. Hundreds of patients may be entered into each study and may receive active or placebo or active and placebo in a random order. Sub groups of responding patients are identified and so are interactions with other medicines that the patient may take. Special target patient groups will be studied at this time - young, old, renal impaired etc.

GW has completed clinical trials in over 2,500 patients and has received regulatory approvals for Sativex® in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis and also for adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Both approvals were secured under the Notice of Compliance with Conditions (NOC/c) policy.
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Sativex ®

What is Sativex ® ?
Sativex® is GW's lead cannabinoid pharmaceutical product, standardized by both composition and dose, that is being developed for the treatment of conditions such as cancer pain, neuropathic pain of various origins, and symptoms of multiple sclerosis.

Sativex is administered as an oral spray which is absorbed by the patient’s mouth. It is composed primarily of a 1:1 ratio of two cannabinoids-CBD (cannabidiol-a non-psychoactive cannabinoid) and THC (delta-9-tetrahydrocannabinol). The CBD:THC formulation is believed to enhances the pain relief of THC while modulating the unwanted psychotropic and other THC-related side effects, such as tachycardia. The spray delivery system keeps THC from entering the blood too rapidly and also minimizes the development of unwanted psychotropic effects.
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What side effects does Sativex® have?
GW's clinical trials have generated over 1000 patient-years of safety data, and adverse events have been predictable and generally well tolerated. Many side effects occur primarily during the early stages of dose adjustment, while patients are identifying their optimal individualized dose and diminish over time or with reduced dose. The most common adverse events (> 10%) reported by patients in Sativex® studies have been somnolence (sleepiness), nausea, and dizziness. These side effects are common to many other prescription medications, particularly pain medications.
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Does approval of Sativex® by a national regulatory authority like Health Canada mean that herbal cannabis will also be legal in that country?
No. The regulatory approvals from Health Canada are specific to Sativex® - there is no change in the law relating to cannabis. In the UK, if an approval is received from the MHRA this would be followed by a change in UK law allowing doctors to prescribe the MHRA-approved medication. This change in law would apply only to such an approved product and would have no direct consequence for the legal status of herbal cannabis for recreational and medical use. This would also be true in the United States.
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Where is Sativex ® available?
In April 2005 GW received regulatory approval for Sativex® in Canada for symptomatic relief of neuropathic pain. In August 2007, Health Canada approved Sativex® as adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Both approvals were secured under the Notice of Compliance with Conditions (NOC/c) policy. Sativex® is marketed in Canada exclusively by Bayer Healthcare.

In the UK, Sativex® is available on prescription on a named patient basis. Sativex® is also available on a compassionate access basis in the Catalonian region of Spain. .

In the US, Sativex® is an investigational drug being developed as an adjunctive (additive) analgesic treatment for patients with advanced cancer whose persistent pain has not been adequately relieved by optimized treatment with strong opioids. The FDA has not approved Sativex® and the product is not available in the United States other than for use in FDA approved clinical trials.
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Who markets Sativex®?
In Canada, Sativex® is marketed by Bayer HealthCare. Once approved in the UK, Bayer will also market Sativex® in that country. Upon approval in Europe (excluding the UK), Sativex® will be marketed by Almirall. Upon approval in the United States, Sativex® will be marketed by Otsuka.
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Investor Relations

Which stock exchange is GW Pharmaceuticals listed on?
GW is listed on the Alternative Investment Market (AIM) of the London Stock Exchange.
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What is the stock exchange symbol for GW Pharmaceuticals?
GWP.
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When is the company's financial year end?
GW's financial year ends on 30 September.
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How do I obtain a copy of the company's annual report?
To receive a copy of GW's latest annual report or interims please contact us.
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Which PR firm does GW Pharmaceuticals use?
Financial Dynamics, Holburn Gate, 26 Southampton Buildings, London, WC2A 1PB. Tel: +44 (0) 20 7831 3113. Fax: +44 (0) 20 7405 8007. Email: david.yates@fd.com
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Who are GW's financial advisers and brokers?
GW's financial adviser is NM Rothschild & Sons and the company's broker is Investec Bank (UK) Ltd.
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