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LONDON, May 09, 2019 -- GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences Inc. (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science,.
GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
GW has developed an oral formulation of purified cannabidiol (CBD), approved as Epidiolex® in the U.S. by the U.S. Food and Drug Administration (FDA) for seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome, two rare and severe early-onset, drug-resistant epilepsy syndromes. This is the first cannabis plant-derived medicine ever approved by the FDA and it has been rescheduled by the U.S. DEA to a schedule V. The medicine was launched in the US as a prescription medicine by our US operating subsidiary, Greenwich Biosciences Inc., on November 1, 2018. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in early 2019.
GW successfully developed the world’s first prescription medicine derived from the cannabis plant, called Sativex® (delta-9-tetrahydrocannibinol and cannabidiol in the EU; nabiximols in the US), which is now approved in over 25 countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop Sativex.
The company has a deep pipeline of additional clinical stage cannabinoid product candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions.
GW Pharmaceuticals was founded in 1998 and is listed on the NASDAQ Global Market (GWPH). The company has operations in both the US and the UK.