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 of a complex botanical mixture comprised of two principal cannabinoid components, cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC), along with specific minor cannabinoids and non-cannabinoid plant components.
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, autism, and schizophrenia.
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 lead product is a liquid formulation of highly purified cannabidiol, or CBD. The FDA approved this product as EPIDIOLEX® (cannabidiol) in June 2018, initially for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older, two rare and particularly difficult to treat forms of epilepsy. The FDA has since approved EPIDIOLEX for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC) in patients one year of age and older, and expanded the age range to include patients one year of age and older who experience seizures associated with LGS or Dravet syndrome. TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. The DEA has descheduled EPIDIOLEX. The product was launched in November 2018 and is now available by prescription only in the U.S.
This product also received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX® for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.* GW is currently evaluating additional clinical development programs in other orphan seizure disorders and autism spectrum disorders. EPIDYOLEX is currently under review by the EMA for seizures associated with TSC.
GW is also developing nabiximols (US USAN name, known as Sativex® outside of the US) for the treatment of spasticity in patients with multiple sclerosis and spinal cord injury and for patients suffering with Post Traumatic Stress Disorder.
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.
*See SmPC for full prescribing & safety information.