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, Drs. Guy and 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 program.
In just one year following its inception, GW commenced its first clinical trials evaluating different cannabinoid formulations as potential therapeutics with an initial focus on the development of Sativex® (Nabiximols), an oral mucosal spray with two principal cannabinoid components, cannabidiol (CBD) and Delta-9 Tetrahydrocannabinol (THC). Sativex has been studied in over 20 randomised placebo-controlled trials including over 3,000 patients and has been the subject of numerous regulatory submissions and approvals. (A list of the countries in which Sativex is approved can be found here).
Working with leading cannabinoid scientists around the world, GW has continued to explore the potential of a range of novel cannabinoid molecules in a number of distinct therapeutic areas including epilepsy, glioma, and schizophrenia.
GW’s lead product candidate is Epidiolex®, is a liquid formulation of pure cannabidiol (CBD) for severe early-onset, drug-resistant epilepsy syndromes. Epidiolex is the result of extensive pre-clinical research of CBD in epilepsy which dates back to 2007 and which has reported significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models. In 2013, GW commenced an orphan clinical program in pediatric epilepsy with initial focus on two rare and particularly difficult to treat forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome (LGS), both of which have been granted orphan drug designation by the U.S. FDA. In addition, we have been granted Fast Track designation for Dravet syndrome by the FDA. GW has since commenced Phase 3 development of Epidiolex in a third pediatric orphan indication, Tuberous Sclerosis Complex (TSC) and expects to commence a Phase 3 trial in Infantile Spasms (IS).
In 2016, the first Phase 3 results of this pivotal program were released (see GW press releases: 14 March 2016, 27 June 2016 & 26 September 2016). GW’s focus is to bring novel, cannabinoid-based prescription medicines to patients in areas of serious unmet need and in which our medicines have the potential to make a real difference to their quality of life. Through the combination of rapid cost-effective product development that addresses these unmet needs, GW seeks to maximise the value of its product opportunities and shareholder returns.
GW’s strategy is to maintain a world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. In seeking to implement this strategy, GW has developed an extensive international network of the most prominent scientists in the cannabinoid field and has also assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical product formulation. GW manufactures its prescription pharmaceutical products to meet the stringent cGMP requirements of the U.S. FDA and other global regulatory authorities. GW establishes controls over all facets of product development, manufacturing and commercial distribution.