GW was co-founded in 1998 by Dr Geoffrey Guy and Dr Brian Whittle, two well-known entrepreneurs in the UK biotech sector. In setting up GW, Dr Guy and Dr Whittle worked closely with both the UK Home Office and the UK’s medicines regulatory authority on establishing necessary licences and procedures so as to facilitate the progress of GW’s cannabinoid research programme. Dr Guy and Dr Whittle also worked with various branches of UK law enforcement to ensure the strictest security surrounds any work conducted involving the company’s cannabis plant material.
Patients have been at the forefront of GW’s efforts since the Group was founded. Unusually, GW was set up specifically in response to a serious unmet medical need and has throughout its history received thousands of supportive letters from patients. Maintaining focus on the potential benefits to patients of its research has been a consistent driving force behind GW’s progress to date.
In 1998-99, there were two major official investigations into cannabinoid science and more broadly the issues related to the medical benefits of cannabis - by the House of Lords in the UK and the National Academy of Sciences, Institute of Medicine in the United States.i,ii,iii. Both of these investigations concluded that there is strong evidence supporting the potential therapeutic effects of components of the cannabis plant particularly in the field of Multiple Sclerosis and pain management, and recommended that clinical trials on appropriate medicinal formulations be performed as soon as possible. GW’s research was highlighted by the House of Lords as holding significant promise.
In just one year following its inception, GW commenced its first clinical trials evaluating different cannabinoid formulations as potential treatments in the fields of MS and pain. Rapidly, GW focused on the development of Sativex, an oromucosal spray with two principal cannabinoid components, Cannabidiol (CBD) and Delta-9 Tetrahydrocannabinol (THC). Since 1999, the safety and efficacy of Sativex has been studied in over 20 randomised placebo-controlled trials including over 3,000 patients.
In 2003, GW entered into its first pharmaceutical licence agreement with Bayer Healthcare AG for the UK marketing rights to Sativex. This agreement was expanded to include Canada later that year. In 2005, GW and Almirall signed a licence agreement granting Almirall exclusive marketing rights to Sativex in Europe (ex-UK). In 2007, GW granted Otsuka the US development and marketing rights to the product.
Sativex was first approved in Canada in 2005 under Health Canada’s Notice of Compliance with conditions (NOC/c) policy for the treatment of neuropathic pain in MS. This approval was extended to cancer pain in 2007.
In May 2009, Sativex was the subject of a regulatory submission in the UK and Spain for the treatment of MS spasticity and was approved in both countries in summer 2010. The UK launch took place in June 2010. Following the achievement of national remibursement status in Spain in February 2011, Sativex was launched in that country in March 2011.
In March 2011, Sativex successfully completed the European Mutual Recognition Procedure (MRP) with the regulatory authorities in six member states(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 United States, the lead indication for Sativex is cancer pain. Following positive data reported in March 2010 from a Phase IIb study, a Phase III clinical programme is now underway.
New cannabinoid targets and research
In only the very recent past, a natural cannabinoid receptor system in the human body has been discovered. This has sparked renewed interest in the therapeutic potential of cannabinoids by identifying important new targets for drugs. In response to important new science and in parallel with the development of Sativex, GW has continued to explore the potential of a range of novel cannabinoid molecules in a number of distinct therapeutic areas. GW has set up relationships with leading cannabinoid scientists including Professor Roger Pertwee, University of Aberdeen, the UK’s leading cannabinoid pharmacologist, Professor Raphael Mechoulam, Professor of Medicinal Chemistry at the Hebrew University, Jerusalem and Professor Vincenzo Di Marzo at Istituto per la Chimica di Molecole di Interesse Biologico in Naples. GW is also pleased to be working with a large number of other researchers around the world.
In mid 2007, GW’s research activities were significantly expanded through the establishment of a global cannabinoid research agreement with Otsuka. Under this agreement, a GW-Otsuka collaboration research team, which incorporates senior scientists from both companies, is evaluating a range of GW cannabinoids as drug candidates within the field of CNS and oncology.
In 2009, GW’s research in the field of type 2 diabetes and metabolic disease was expanded through an exclusive strategic alliance with Professor Mike Cawthorne and the Clore Laboratory, University of Buckingham. As part of this alliance, a dedicated section of the Clore Laboratory has been named the “GW Metabolic Research Laboratory”.
In early 2012, Professor Vincenzo Di Marzo agreed to direct GW’s global pre-clinical research programme and assumed the title of Research Director of GW Research Ltd and GW’s Cannabinoid Research Institute. Professor Di Marzo is one of the world’s leading cannabinoid scientists, co-author of more than 460 peer-reviewed publications, and in 2010 was recognised as Thompson Reuters 'top scientist of the decade' for pharmacology and toxicology. He has previously served as President of the International Cannabinoid Research Society (ICRS) and is a recipient of ICRS’s Mechoulam Award for “outstanding contributions to cannabinoid research”.
British Medical Association (1997) “Therapeutic Uses of Cannabis”, Morgan, D.R. (editor), Ashton, C.H (principal author), Holdcroft, A., Mars, S., Moffat, T., Pertwee, R.G. and Wall, P. (contributing authors), Harwood Academic Publishers, Amsterdam.