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GW Pharmaceuticals - FAQ about Sativex

Smokin Moose

Fallen Cannabis Warrior
GW in General
When was GW established?
The Group was founded in early 1998 and was first granted research licences by the Home Office in June 1998.
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What is GW Pharmaceuticals?
GW Pharmaceuticals was established in 1998 after discussions with UK government officials. The company operates under research licences issued by the UK Home Office. Additional licences are needed to cover those professionals nominated by GW and approved by the Home Office to perform specific sections of the programme. Such professionals include analytical chemists, formulation pharmacists, pharmaceutical Qualified Persons, clinical research associates, hospital pharmacists and clinical investigators.

GW is a pharmaceutical group developing a portfolio of prescription medicines derived from the active components of the cannabis plant to meet patient needs in a wide range of therapeutic conditions. 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, Spinal Cord Injury, Cancer Pain and Rheumatoid Arthritis.

In April 2005 Sativex® received approval from Health Canada for use as an adjunctive therapy for the relief of neuropathic pain in patients with Multiple Sclerosis (MS) and will be exclusively marketed in Canada by Bayer Healthcare Canada.
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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 prescription medicines derived from cannabis to meet patient needs in a wide variety of indications. GW's first medicine, Sativex®, was approved by Health Canada for the symptomatic relief of neuropathic pain in patients with MS in April 2005 and launched in Canada in June 2005. Sativex® is exclusively marketed by Bayer HealthCare in Canada.

GW's clinical research has initially focussed on Multiple Sclerosis and neuropathic pain and has extended into Spinal Cord Injury, Cancer Pain and rheumatoid arthritis. The Company plans to continue to extend its research programme into new areas, part of which will be achieved via the Cannabinoid Research Institute (CRI), a wholly owned division of GW that conducts exploratory research.
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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.
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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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What is to prevent the large drug companies from stepping in and taking over?
GW already has a significant head start in terms of botanical research and a considerable lead in pharmaceutical development and clinical research. Our products are also protected by patents and plant variety rights. The patents cover methods of extraction, preparation of intermediates, formulation technology, drug delivery technology and use patents. The most likely consequence of interest from large pharmaceutical companies wishing to be involved in cannabinoid research is that they would approach us to collaborate.
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Cannabinoids and Cannabis-Based Medicines
Why does GW cultivate its own cannabis plant?
The absolute requirement for any 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.

GW's first 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.

We are currently producing significant quantities of THC, CBD (cannabidiol), THC-V (the propyl anologue of THC), CBC-V (the propyl analogue of cannabichromene) and CBG (cannabigerol). Nothing is known of the pharmacology and possible therapeutic effects of CBC and CBG specifically.

Our clinical programme is comparing a number of cannabinoid ratios against placebo in each illness to establish which ratios are most suitable for each patient group.
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What is a "botanical extract"?
When we talk about a "botanical extract" we mean an extract of the chosen part of the plant, and here we are talking about the aerial part of the plant, not the roots.

This extract provides only a step in an extensive pharmaceutical development process. By employing specific extraction methods under Good Manufacturing Practice, we arrive at pharmaceutical grade extracted material which is highly standardized in composition. From there we can then proceed to formulation work and continue to incorporate those materials in the appropriate drug delivery modalities. Each step is subject to quality control procedures.
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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 but 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 and research is ongoing into neuroprotective and immunomodulatory effects.
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What are GW's medicines?
GW's medicines are derived from standardised botanical extracts of proprietary cannabis plant varieties bred to exhibit a pre-determined content of cannabinoids. These extracts are incorporated into non-smoked drug delivery technologies and then undergo pre-clinical and clinical testing prior to submitting applications to pharmaceutical regulatory authorities.
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How are GW's cannabis-based medicines likely to be administered to patients?
Cannabis based medicines must be administered by means of a delivery system that comports with the requirements of modern medical practices, certainly not by smoking. This delivery system must enable a patient to obtain therapeutic relief without incurring undue side effects. GW's first product, Sativex®, is an oro-mucosal spray.
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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. 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.

Only a scientifically-based cannabis-derived product, which meets the standards of modern pharmaceutical practice, and which has been approved by the appropriate regulatory agencies, would be suitable for distribution to patients as a prescription medicine. Any product which is smoked would clearly never meet such standards.
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Are GW's cannabis based medicines safe?
Data from GW's clinical trials confirm that its medicines are generally well tolerated. The trials have generated over 1000 patient-years of safety data. In clinical trials, the most frequent side-effects included nausea, fatigue, dizziness and application site reactions. Side-effects were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.
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Now that Sativex® has been approved in Canada does this mean that cannabis is legal?
No. The regulatory approval of Sativex® in Canada applies only to Sativex® and has no direct consequence for the legal status of herbal cannabis for recreational and medical use.
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How will these cannabis based medicines become legal in the UK?
The UK government has stated repeatedly that it will permit, subject to regulatory approval from the MHRA, cannabis-based medicines to be re-scheduled under the Misuse of Drugs Regulations so as to enable their general prescription. These changes can be made swiftly.
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Do patients get high?
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 looking at different forms of cannabis from those known to recreational users of the drug?
Those intending to use cannabis for recreational purposes have focused on producing plant varieties that exhibit almost exclusively THC. We believe very strongly that many of the advantages of using a botanical extract come from the inclusion of other components of cannabis in addition to THC, specifically cannabidiol or CBD. Most all of the cannabis grown in North America is virtually devoid of CBD.

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 is the current status of the GW research programme?
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 relates to the side effect profile of a product. 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.

EFFICACY Prior to submission of our 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 1 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 2 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.

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 2 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 now completed a number of Phase III clinical trials and has further Phase III trials underway.
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Sativex ®
What is Sativex ® ?
Sativex® is GW's lead cannabis-based medicine and is a pharmaceutically-formulated extract of the active components of the cannabis plant taken as an oro-mucosal spray into the mouth. Sativex® was approved in Canada for the relief of neuropathic pain in Multiple Sclerosis (MS) in April 2005 and was launched in June 2005. Sativex® is being marketed in Canada exclusively by Bayer HealthCare.
 
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ZedRules

New Member
I would gladly give Sativex a try if it were Kosher in Cali...still I use what I can get.;)
 

Pinch

New Member
Thanks M Moose...very complete look at G.W.

Sativex® is being marketed in Canada exclusively by Bayer HealthCare. Canada remains the only country in the world to have approved Sativex.


Sativex is on the fast track to US/FDA approval and they estimate approval by 2010-12.

GW Pharmaceuticals, which is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes, has entered into a long term strategic cannabinoid alliance with Japanese drug company Otsuka Pharmaceutical to develop and market Sativex, GW's lead product, in the US.

In 2006, the Food and Drug Administration (FDA) permitted Sativex to enter directly into late stage development in the US for the treatment of pain in patients with advanced cancer, and GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence this year. (2007)
 

Pinch

New Member
Canada has it, Australia shouldn't be far behind.:3::peace:
 

Smokin Moose

Fallen Cannabis Warrior
You know Pinch, I am giving a talk on mmj to the counsellors at the Territory Government Drug and Alcohol Unit (Intake) next week. This latest info on Sativex is on my briefing list.
The Australian Capital Territory where I live has been at the forefront of legalising mmj in Australia, so all the info I give them is crucial. I try and educate as many health care professionals as I can.
 

ZedRules

New Member
Moose you are doing a fantastic job of bringing in this technical data for healthcare professionals ( I'm A Registered Respiratory Therapist doing criticalcare in adults ), scientific people and politicians alike, we all need well researched material to make informed decisions on the need for more studies and legislation favoring researching the qualities of medical cannabis.:31:
Not to mention that the pharma companies maybe smelling the next cash cow and may let up the pressure they had used to interfer with proper research.
 
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