History & Approach

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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 an oral mucosal spray with two principal cannabinoid components, cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC).

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 a liquid formulation of highly purified CBD being investigated for severe earlyonset, drug-resistant epilepsy syndromes. This product is the result of extensive pre-clinical research of CBD in epilepsy which dates back to 2007. In 2013, GW commenced an orphan clinical program in paediatric 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.

GW submitted a New Drug Application with the FDA , which was approved by the FDA on June 25th, 2018 for the treatment of seizures associated with LGS or Dravet syndrome. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in the first quarter of 2019. To date, GW has received Orphan Drug Designation from the FDA for Dravet syndrome, LGS and TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.

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 maximize the value of its product development 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.