FAQs

The Group was founded in early 1998 and was first granted licenses by the Home Office in June 1998 to research and develop cannabinoid prescription medications.

GW is a pharmaceutical group developing a portfolio of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic conditions. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines , including Sativex® Oromucosal Spray, to meet patient needs in a wide range of therapeutic indications

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes.

GW has approximately 130 employees.

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.

GW aims to bring cannabinoid prescription medications to market in order to provide patients suffering from serious conditions with previously-unavailable treatment options which make a real difference to their quality of life. Through rapid cost-effective product development, addressing market needs, and establishing commercial partnerships, GW seeks to maximise the value of its products and shareholder returns. GW’s primary focus is in the field of cannabinoid science and in the research, development and commercialisation of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. GW's clinical research is initially focused on Multiple Sclerosis, cancer pain and neuropathic pain. The Company is also extending its research programme into new areas such as oncology, diabetes, epilepsy and psychiatric illness.

Yes. GW operates under licences granted by the UK Home Office. These licences allow the Group to research and develop cannabinoid prescription medications. GW’s products are being researched and prescribed in 22 countries around the world and the relevant governmental authority in each such country has granted GW the necessary controlled substance licences.

GW is a UK-based company but its research network and operations stretches around the world. To date, GW has exported Sativex and other cannabinoid research materials to a total of 28 countries. The export of Sativex has been both for the purposes of supplying prescriptions as well as for use in clinical trials. The list of countries includes much of Europe, as well as the US and Canada, Australasia, South Africa and parts of Latin America

To date, GW has completed clinical trials in over 3,000 patients, including over 20 Phase II and Phase III trials. These trials are conducted around the world and have included patients with a range of different medical conditions, including multiple sclerosis, cancer pain, neuropathic pain, and rheumatoid arthritis. For more information on the target therapeutic areas for Sativex and the clinical trials completed to date. please click here

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.

GW uses 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 strict Standard Operating Procedures, as well as international Good Manufacturing Practice standards.

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 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.

Cannabinoids are a group of chemical compounds found only in the cannabis plant. Different cannabinoids appear to have different pharmacological effects. Over 60 different cannabinoids have so far been identified but the role and importance of many of these has yet to be fully understood. Cannabinoids known to have pharmacological effects of therapeutic relevance include Delta-9 Tetrahydrocannabinol (THC), Cannabidiol (CBD), Cannabinol (CBN), Cannabichromene (CBC), Cannabigerol (CBG) and Delta-9-tetrahydrocannabivarin (THCV). Certain cannabinoids have been shown to have analgesic, anti-spasmodic, anti-convulsant, anti-tremor, anti-psychotic, anti-inflammatory, anti-cancer, anti-oxidant, anti-emetic and appetite-stimulant or appetite-suppressant properties.

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.

Sativex is a cannabinoid pharmaceutical product standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, which has been, and continues to be, tested in properly controlled preclinical and clinical studies. Crude herbal cannabis in any form--including a crude extract or tincture--is none of those things.

We believe that most patients and most physicians should accept only a product that meets the standards of modern medicine. Since the company’s founding in 1998, GW has consistently maintained a single objective: to develop modern medicines that satisfy international standards for quality, safety, and efficacy, while also meeting the medical needs of seriously and chronically ill patients.

Moreover, GW has conducted its program exclusively in accordance with the parameters of modern medical and pharmaceutical practice.

GW is entirely focused on creating cannabinoid medications that can be made available on prescription to patients 1) whose conditions have been shown to benefit from such medicines and 2) who wish to obtain their medical treatment from their physicians in accordance with the standards of modern medical practice.

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.

GW has never endorsed or supported the idea of distributing or legalizing crude herbal cannabis for medical use. In both our publications and presentations, we have consistently maintained that only a cannabinoid medication--one that is standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, and tested in properly controlled preclinical and clinical studies--can meet the standards of regulatory authorities around the world, including those of the FDA. These criteria are also mandatory if the modern medical model—informed patients working with, and being advised by, knowledgeable physicians to identify appropriate treatment options--is ever to be attained with a cannabinoid medication.

We have also repeatedly stressed that these regulatory processes provide important protections for patients, and we believe that any cannabinoid medication must be subjected to, and satisfy, such rigorous scrutiny.

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.

One of the cannabinoids in Sativex is THC whereas the other principal cannabinoid is CBD, a non-psychoactive molecule. Evidence suggests that CBD may modulate many of the unwanted effects of THC. Hence, through the incorporation of CBD and the utilization of an oromucosal spray delivery system which is administered through careful self-titration (dose adjustment) and which keeps THC from entering the blood too rapidly., 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. There is no evidence from Sativex clinical trials that patients obtain a high akin to that sought by recreational cannabis users.

All of GW’s non-Sativex cannabinoid research focuses on cannabinoid molecules other than THC. These other molecules are not psychoactive.

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.

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 body system.

GW's clinical trials programme 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 in developing a pharmaceutical product must 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 patient's 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.

Sativex is the world’s first prescription medicine derived from the cannabis plant. The medicine is standardized by both composition and dose and is being developed for the treatment of conditions such as spasticity in multiple sclerosis, cancer pain, and neuropathic pain of various origins

Sativex is administered as an oral spray which is absorbed by the patient’s mouth. Sativex® contains active ingredients called ‘cannabinoids’, which are extracted from cannabis plants grown and processed under strictly controlled conditions. 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 enhance the therapeutic benefits 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.

Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains. A receptor is a site on a brain cell where certain substances can stick or “bind” for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a ‘dimming down’ of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.

Main effects of CBD: Anti-inflammatory, anticonvulsant, antipsycotic, anti-oxidant, neuroprotective, immunomodulatory

Main effects of THC: Analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant, anti-emetic

Multiple sclerosis (MS) is commonest disabling neurological disease affecting the central nervous system (CNS) in young adults. It affects around 100, 000 in the UK and is most commonly diagnosed between the ages of 20 and 40. Women are twice as likely to be diagnosed as men.

Spasticity is an involuntary increase in muscle tone. When the muscle is moved, there is more resistance to this movement than there normally would be and the muscle feels stiff or rigid. Increased tone can mean muscles are slow to relax, and this can cause stiffness. Spasticity may also cause them to jerk in an uncontrolled way. This is one kind of muscle 'spasm' that people with MS can experience. If muscles jerk repeatedly, this is known as 'clonus' for example when a foot taps repetitively on the floor.

GW's clinical trials have generated over 1300 patient-years of safety data, and adverse events have been predictable and generally well tolerated. The most common side effects of Sativex® are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued. These side effects are common to many other prescription medications, particularly pain medications.

There is no evidence to suggest that Sativex® produces a ‘high’ comparable to recreational cannabis.

One of the cannabinoids in Sativex is THC whereas the other principal cannabinoid is CBD, a non-psychoactive molecule. Evidence suggests that CBD may modulate many of the unwanted effects of THC. Hence, through the incorporation of CBD and the utilization of an oromucosal spray delivery system which is administered through careful self-titration (dose adjustment) and which keeps THC from entering the blood too rapidly, patients are able to obtain symptom relief without experiencing a 'high'. Patients emphasise that they seek to obtain the medical benefits without intoxication and, when taking Sativex, are able to adjust their dose to achieve symptom improvement with the minimum of unwanted effects.

However as with all medicines, there is the potential for Sativex® to cause unwanted effects such as dizziness or fatigue when it is first used.

In the UK and Canada, Sativex is marketed by Bayer Schering Pharma. In Europe (excluding the UK), Sativex will be marketed by Almirall. Upon approval in the United States, Sativex will be marketed by Otsuka.

Sativex® has now been approved in the UK, Spain, Canada and New Zealand to treat spasticity due to multiple sclerosis.

In Canada, as well as MS spasticity, Sativex® is also approved under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy for the relief of neuropathic pain and advanced cancer pain.

In additional European countries, Sativex® has successfully completed the European Mutual Recognition Procedure (MRP) with the regulatory authorities in all six countries (Germany, Italy, Denmark, Sweden, Austria and the Czech Republic) confirming that Sativex meets their requirements for approval. The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, we expect each country to then issue a national marketing authorisation. We anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.

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.

No. Regulatory approvals from medicines regulatory authorities are specific to Sativex® - there is no change in the law relating to cannabis. Any changes in regulations to permit Sativex to be prescribed 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 is true for all countries around the world, including the United States.

GW is listed on the Alternative Investment Market (AIM) of the London Stock Exchange.

GWP.

GW's financial year ends on 30 September.

To receive a copy of GW's latest annual report or interims please contact us by emailing info@gwpharm.com

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GW's financial adviser is NM Rothschild & Sons and the company's broker is Peel Hunt LLP