GW Pharmaceuticals

Last updated

GW Pharmaceuticals Limited
Formerly
  • GW Pharmaceuticals Group PLC (2001–2001)
  • GW Pharmaceuticals PLC (2001–2021) [1]
Company type Subsidiary
Industry Pharmaceutical industry
Founded1998;26 years ago (1998)
Founder
  • Geoffrey Guy
  • Brian Whittle
Headquarters Cambridge,
United Kingdom
Key people
Justin Gover (CEO)
Products
RevenueIncrease2.svg $527 million (2020)
Decrease2.svg -$58 million (2020)
Total assets Increase2.svg $939 million (2020)
Total equity Increase2.svg $741 million (2020)
Number of employees
1,161 (2020)
Parent Jazz Pharmaceuticals
Website gwpharm.co.uk OOjs UI icon edit-ltr-progressive.svg
Footnotes /references
[2]

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.

Contents

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

Related Research Articles

<span class="mw-page-title-main">Tetrahydrocannabinol</span> Psychoactive component of cannabis

Tetrahydrocannabinol (THC) is a cannabinoid found in cannabis. It is the principal psychoactive constituent of cannabis and one of at least 113 total cannabinoids identified on the plant. Although the chemical formula for THC (C21H30O2) describes multiple isomers, the term THC usually refers to the delta-9-THC isomer with chemical name (−)-trans9-tetrahydrocannabinol. It is a colorless oil.

<span class="mw-page-title-main">Medical cannabis</span> Cannabis sativa L. (Marijuana; Hemp) used medicinally

Medical cannabis, medicinal cannabis or medical marijuana (MMJ), refers to cannabis products and cannabinoid molecules that are prescribed by physicians for their patients. The use of cannabis as medicine has a long history, but has not been as rigorously tested as other medicinal plants due to legal and governmental restrictions, resulting in limited clinical research to define the safety and efficacy of using cannabis to treat diseases.

<span class="mw-page-title-main">Cannabinoid</span> Compounds found in cannabis

Cannabinoids are several structural classes of compounds found in the cannabis plant primarily and most animal organisms or as synthetic compounds. The most notable cannabinoid is the phytocannabinoid tetrahydrocannabinol (THC) (delta-9-THC), the primary psychoactive compound in cannabis. Cannabidiol (CBD) is also a major constituent of temperate cannabis plants and a minor constituent in tropical varieties. At least 113 distinct phytocannabinoids have been isolated from cannabis, although only four have been demonstrated to have a biogenetic origin. It was reported in 2020 that phytocannabinoids can be found in other plants such as rhododendron, licorice and liverwort, and earlier in Echinacea.

<span class="mw-page-title-main">Cannabidiol</span> Phytocannabinoid discovered in 1940

Cannabidiol (CBD) is a phytocannabinoid, one of 113 identified cannabinoids in cannabis plants, along with tetrahydrocannabinol (THC), and accounts for up to 40% of the plant's extract. It was discovered in 1940 and as of 2022, clinical research on CBD included studies related to the treatment of anxiety, addiction, psychosis, movement disorders, and pain, but there is insufficient high-quality evidence that CBD is effective for these conditions. CBD is sold as a herbal dietary supplement and promoted with yet unproven claims of particular therapeutic effects.

<span class="mw-page-title-main">Cannabidivarin</span> Group of stereoisomers

Cannabidivarin (CBDV, GWP42006) is a non-intoxicating psychoactive cannabinoid found in Cannabis. It is a homolog (chemistry) of cannabidiol (CBD), with the side-chain shortened by two methylene bridges (CH2 units).

<span class="mw-page-title-main">Nabilone</span> Synthetic cannabinoid

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<span class="mw-page-title-main">Nabiximols</span> Specific cannabis extract

Nabiximols is a specific Cannabis extract that was approved in 2010 as a botanical drug in the United Kingdom. Nabiximols is sold as a mouth spray intended to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis; it was developed by the UK company GW Pharmaceuticals. In 2019, it was proposed that following application of the spray, nabiximols is washed away from the oral mucosa by the saliva flow and ingested into the stomach, with subsequent absorption from the gastro-intestinal tract. Nabiximols is a combination drug standardized in composition, formulation, and dose. Its principal active components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). Each spray delivers a dose of 2.7 mg THC and 2.5 mg CBD.

<span class="mw-page-title-main">Geoffrey Guy</span>

Geoffrey William Guy is a British pharmacologist, physician, businessman and academic, who co-founded GW Pharmaceuticals and has developed treatments using compounds found in cannabis, which are the first cannabis-based medicines approved by and available on the British National Health Service (NHS).

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<span class="mw-page-title-main">Medical cannabis in the United States</span>

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<span class="mw-page-title-main">Dronabinol</span> Generic name of Δ9-THC in medicine

Dronabinol, sold under the brand names Marinol and Syndros, is the generic name for the molecule of delta-9-tetrahydrocannabinol (THC) in the pharmaceutical context. It has indications as an appetite stimulant, antiemetic, and sleep apnea reliever and is approved by the U.S. FDA as safe and effective for HIV/AIDS-induced anorexia and chemotherapy-induced nausea and vomiting.

Jazz Pharmaceuticals plc is a global biopharmaceutical company with a focus on oncology and neuroscience. It was founded in 2003 in California, United States. One of the company's considerable products is the United States Food and Drug Administration (FDA) approved drug Xyrem, the sodium salt of the naturally occurring neurotransmitter γ-Hydroxybutyric acid (GHB). In 2017, net product sales of Xyrem were $1.187 billion, which represented 74% of the company's total net product sales. In 2019, Jazz was granted FDA-approval to market Sunosi with indications for treating excessive daytime sleepiness (EDS) in narcolepsy as well as obstructive sleep apnea (OSA). In 2022, it was announced that Axsome Therapeutics would be acquiring Sunosi from Jazz Pharmaceuticals.

<span class="mw-page-title-main">Charlotte's Web (cannabis)</span> Strain of medical marijuana

Charlotte's Web is a brand of high-cannabidiol (CBD), low-tetrahydrocannabinol (THC) products derived from industrial hemp and marketed as dietary supplements and cosmetics under federal law of the United States. It is produced by Charlotte's Web, Inc. in Colorado. Hemp-derived products do not induce the psychoactive "high" typically associated with recreational marijuana strains that are high in THC. Charlotte's Web hemp-derived products contain less than 0.3% THC.

<span class="mw-page-title-main">Botanical drug</span> Plant ingredients marketed for treatment of a disease

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<span class="mw-page-title-main">Cannabis in Iowa</span>

Cannabis in Iowa is illegal for recreational use if classified as marijuana but consumable hemp products including CBD products are legal for consumers to possess and registered retailers to sell. Possession of even small amounts of marijuana is a misdemeanor crime. The state has a medical program for patients with qualifying debilitating medical conditions that allows for the legal sale and possession of no more than 4.5g of THC per patient every 90-day period. Allowed modes of consumption are oral & topical forms including, but not limited to; tablets and tinctures, nebulizable inhalable forms, suppositories, and vaporization.

<span class="mw-page-title-main">Cannabis in Idaho</span>

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<span class="mw-page-title-main">Cannabis in Sweden</span>

Cannabis in Sweden is illegal for all purposes. It is illegal for recreational purposes, for most medical purposes and possession of even small amounts of cannabis is a criminal offence. Consequently, limited medical usage of cannabis-based drugs is only allowed for specific conditions.

<span class="mw-page-title-main">Cannabis in Singapore</span>

Cannabis is currently illegal in Singapore for recreational purposes. Possession or consumption can result in a maximum of 10 years in prison, with a possible fine of $20,000, as well as caning, under the Misuse of Drugs Act. Trafficking, import or export of more than 500 grams may result in the death penalty. Medical cannabis is also not permitted, with very limited exceptions for cannabidiol (CBD) pharmaceuticals.

<span class="mw-page-title-main">Medical cannabis research</span> Medical research on using cannabis

Medical cannabis research includes any medical research on using cannabis. The earliest systematic studies of physiological effects of cannabis-derived chemical were conducted in the 1920's. The level or research activity in this area remained relatively low and constant until 1966, when a 10-fold increase in publication activity occurred within 10 years. After the adoption of the Convention on Psychotropic Substances in 1971 there was a drop in research publishing, which continued till ca. 1987. Since then, cannabis research has been continuously on the rise. There is no apparent inflection point is 2013, when Uruguay "became the first country in the world to fully regulate its marijuana market, from production to consumption and distribution." Since then a large number of countries enacted policies on medical cannabis research, and there are substantial differences between such policies in different countries.

The Cannabinoid Research Initiative of Saskatchewan (CRIS) was founded in 2017 as an interdisciplinary research team of clinician researchers (medical and veterinary), basic scientists, and social scientists. CRIS aims to obtain scientific evidence about the application of Cannabinoids and Medical cannabis to humans and animals, for health, disease and disorders. The team was initially based at the University of Saskatchewan, in Saskatoon, Saskatchewan, Canada but includes researchers based at the University of Regina and University of Alberta. A strategic management executive committee coordinates activities and develops research opportunities. The sections of CRIS include: Analytical Evaluations, Human Clinical Studies, Biomedical studies, Veterinary Sciences, Knowledge Translation and Studies of Cannabinoids and Society. CRIS members participate in the Canadian Consortium for the Investigation of Cannabinoids, and the International Cannabinoid Research Society.

References

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  2. "GW Pharmaceuticals PLC 2020 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
  3. 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.
  4. Goldschmidt, Debra; Scutti, Susan (25 June 2018). "FDA approves first cannabis-based drug". CNN .
  5. 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.
  6. Breen, Bill (1 February 2004). "The Cannabis Conundrum". Fast Company .
  7. Breen, Bill (1 February 2004). "Dr. Dope's Connection". Fast Company .
  8. "GW Pharma aims for $150m in Nasdaq offering" . Financial Times. 18 June 2014.
  9. "UK Cannabis Grower on a High With Wall Street Funding Bid". International Business Times . 21 December 2013.
  10. Drury, Tracey (6 June 2014). "Cuomo OKs limited medical marijuana trial in NYS". American City Business Journals .
  11. "Jazz Pharmaceuticals Completes Acquisition of GW Pharmaceuticals plc" (Press release). PR Newswire. 5 May 2021.
  12. Sharrow, Ryan (5 May 2021). "Jazz Pharmaceuticals shares rise on $7.2B acquisition of cannabis-based drugmaker". American City Business Journals .
  13. "The man who secretly (and legally) grows 20 tonnes of cannabis a year". The Guardian . 17 April 2011.
  14. "Cannabinoid liquid formulations for mucosal amdinistration [sic]". Google Patents.
  15. "GW Pharmaceuticals regains exclusive commercialisation rights to Sativex® (nabiximols) in the UK from Bayer" (Press release). GW Pharmaceuticals. 2 March 2020.
  16. Medical Cannabis Strains – Geoffrey Guy, MD (GW Pharmaceuticals, UK (Conference). 23 February 2010 via YouTube.
  17. Ward, Andrew (9 January 2014). "GW raises nearly $90m to develop childhood epilepsy treatment" . Financial Times .
  18. "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.
  19. "FDA approves country's first medicine made from marijuana". STAT . 25 June 2018.
  20. Kollewe, Julia (25 June 2018). "UK epilepsy drug to become first cannabis-based medicine in US". The Guardian .
  21. "Epidyolex". European Medicines Agency. 24 June 2019.
  22. "Medical cannabis product approved for epilepsy". BBC News . 23 September 2019.