GW Pharmaceuticals Limited [ 1] is a British pharmaceutics company known for its multiple sclerosis treatment product nabiximols (brand name, Sativex) which was the first natural cannabis plant derivative to gain market approval in any country.[ 3] Another cannabis-based product, Epidiolex , was approved for treatment of epilepsy by the US Food and Drug Administration in 2018.[ 4] It is a subsidiary of Jazz Pharmaceuticals .
History
GW Pharmaceuticals was founded in 1998 by doctors Geoffrey Guy and Brian Whittle. That year, they obtained a cultivation license from the United Kingdom Home Office and the MHRA , allowing the company to cultivate, possess and supply cannabis to conduct scientific research concerning medical cannabis .[ 5]
Later in 1998, GW Pharmaceuticals entered into a contract with Hortapharm B.V. , a cannabis research and development corporation based in Amsterdam.[ 6] [ 7]
In 2001, GW Pharmaceuticals listed on the Alternative Investment Market , the junior market of the London Stock Exchange .[ 8] In May 2013, the company became dual-listed on the NASDAQ and AIM.[ 9]
In 2014, the company made a deal with New York to develop clinical trials using cannabidiol (CBD) to treat children who suffer from seizures and other medical complications.[ 10]
In May 2021, Jazz Pharmaceuticals acquired the company.[ 11] [ 12]
Products
Sativex
Nabiximols (trade name Sativex ) is a botanical drug that is a cannabis extract, administered as a mouth spray; it was approved in the UK in 2010 as a treatment for multiple sclerosis (MS) patients to alleviate neuropathic pain , spasticity , overactive bladder, and other symptoms.[ 13]
Nabiximols is made with two unknown Cannabis strains , and is extracted with ethanol and carbon dioxide .[ 14]
In 2020, GW Pharmaceuticals concluded a partnership with Bayer for the distribution of Sativex in the UK.[ 15] It has an estimated annual production of 100 tons of medicinal cannabis.[ 16]
Epidiolex
In 2015, GW Pharmaceutical initiated Phase 3 clinical trials of cannabidiol oral solution for treatment of two rare disease in children – Dravet syndrome and Lennox–Gastaut syndrome .[ 17] In August 2015, GW received FDA Fast Track Development Program designation from the US Food and Drug Administration for use of the drug candidate to treat newborns with epilepsy.[ 18]
The drug, under the brand name Epidiolex, was given US Food and Drug Administration approval in June 2018.[ 19] [ 20] It was subsequently given European EMA approval in September 2019 under the brand name Epidyolex.[ 21] [ 22]
See also
References
^ a b "GW PHARMACEUTICALS LIMITED overview - Find and update company information - GOV.UK" . Companies House . 15 February 2001. Retrieved 3 August 2023 .
^ "GW Pharmaceuticals PLC 2020 Form 10-K Annual Report" . U.S. Securities and Exchange Commission .
^ Landau, Elizabeth (21 June 2010). "World's first fully approved cannabis drug on sale in UK" . CNN . Archived from the original on 18 May 2012.
^ Goldschmidt, Debra; Scutti, Susan (25 June 2018). "FDA approves first cannabis-based drug" . CNN .
^ Mathre, Mary Lynn (July 1997). Cannabis in Medical Practice: A Legal, Historical, and Pharmacological Overview of the Therapeutic Use of Marijuana (Google eBook) . ISBN 9780786403615 – via Google Books .
^ Breen, Bill (1 February 2004). "The Cannabis Conundrum" . Fast Company .
^ Breen, Bill (1 February 2004). "Dr. Dope's Connection" . Fast Company .
^ "GW Pharma aims for $150m in Nasdaq offering" . Financial Times . 18 June 2014.
^ "UK Cannabis Grower on a High With Wall Street Funding Bid" . International Business Times . 21 December 2013.
^ Drury, Tracey (6 June 2014). "Cuomo OKs limited medical marijuana trial in NYS" . American City Business Journals .
^ "Jazz Pharmaceuticals Completes Acquisition of GW Pharmaceuticals plc" (Press release). PR Newswire . 5 May 2021.
^ Sharrow, Ryan (5 May 2021). "Jazz Pharmaceuticals shares rise on $7.2B acquisition of cannabis-based drugmaker" . American City Business Journals .
^ "The man who secretly (and legally) grows 20 tonnes of cannabis a year" . The Guardian . 17 April 2011.
^ "Cannabinoid liquid formulations for mucosal amdinistration [sic]" . Google Patents .
^ "GW Pharmaceuticals regains exclusive commercialisation rights to Sativex® (nabiximols) in the UK from Bayer" (Press release). GW Pharmaceuticals. 2 March 2020.
^ Medical Cannabis Strains – Geoffrey Guy, MD (GW Pharmaceuticals, UK (Conference) . 23 February 2010 – via YouTube .
^ Ward, Andrew (9 January 2014). "GW raises nearly $90m to develop childhood epilepsy treatment" . Financial Times .
^ "GW Pharmaceuticals Receives FDA Fast Track and EMA Orphan Designations for Intravenous Cannabidiol in the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)" (Press release). GlobeNewswire . 6 August 2015.
^ "FDA approves country's first medicine made from marijuana" . STAT . 25 June 2018.
^ Kollewe, Julia (25 June 2018). "UK epilepsy drug to become first cannabis-based medicine in US" . The Guardian .
^ "Epidyolex" . European Medicines Agency . 24 June 2019.
^ "Medical cannabis product approved for epilepsy" . BBC News . 23 September 2019.
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