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 licenses and procedures so as to facilitate the progress of GW’s cannabinoid research program. A few months after its inception, Justin Gover joined the company as its first Chief Executive Officer.
In 1999, 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 is a liquid formulation of highly purified CBD. In June 2018, the FDA approved this product as Epidiolex® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, two rare and particularly difficult to treat forms of epilepsy, in patients 2 years and older. The product was launched in November 2018 and is now available by prescription in the U.S.
GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected opinion date mid-2019. GW is currently evaluating additional clinical development programs in other orphan seizure disorders and autism spectrum 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.