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GW Pharmaceuticals

GW Pharmaceuticals Limited[2] 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

  • Dronabinol
  • Marinol
  • Nabilone
  • Medical use of cannabis

External links

References

  1. GW Pharmaceuticals PLC 2020 Form 10-K Annual Report U.S. Securities and Exchange Commission^
  2. GW PHARMACEUTICALS LIMITED overview - Find and update company information - GOV.UK Companies House, 2001-02-15, retrieved 2023-08-03^
  3. Elizabeth Landau. World's first fully approved cannabis drug on sale in UK CNN, 21 June 2010^
  4. Debra Goldschmidt, Susan Scutti. FDA approves first cannabis-based drug CNN, 25 June 2018^
  5. Mary Lynn Mathre. Cannabis in Medical Practice: A Legal, Historical, and Pharmacological Overview of the Therapeutic Use of Marijuana (Google eBook) July 1997^
  6. Bill Breen. The Cannabis Conundrum Fast Company, 1 February 2004^
  7. Bill Breen. Dr. Dope's Connection Fast Company, 1 February 2004^
  8. GW Pharma aims for $150m in Nasdaq offering Financial Times, June 18, 2014^
  9. UK Cannabis Grower on a High With Wall Street Funding Bid International Business Times, 21 December 2013^
  10. Tracey Drury. Cuomo OKs limited medical marijuana trial in NYS American City Business Journals, 6 June 2014^
  11. Jazz Pharmaceuticals Completes Acquisition of GW Pharmaceuticals plc PR Newswire, 5 May 2021^
  12. Ryan Sharrow. Jazz Pharmaceuticals shares rise on $7.2B acquisition of cannabis-based drugmaker American City Business Journals, 5 May 2021^
  13. The man who secretly (and legally) grows 20 tonnes of cannabis a year The Guardian, April 17, 2011^
  14. Cannabinoid liquid formulations for mucosal Google Patents^
  15. GW Pharmaceuticals regains exclusive commercialisation rights to Sativex® (nabiximols) in the UK from Bayer GW Pharmaceuticals, 2 March 2020^
  16. Medical Cannabis Strains – Geoffrey Guy, MD (GW Pharmaceuticals, UK (Conference) 23 February 2010^
  17. Andrew Ward. GW raises nearly $90m to develop childhood epilepsy treatment Financial Times, 9 January 2014^
  18. GW Pharmaceuticals Receives FDA Fast Track and EMA Orphan Designations for Intravenous Cannabidiol in the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) GlobeNewswire, 6 August 2015^
  19. FDA approves country's first medicine made from marijuana STAT, 25 June 2018^
  20. Julia Kollewe. UK epilepsy drug to become first cannabis-based medicine in US The Guardian, 25 June 2018^
  21. Epidyolex European Medicines Agency, 24 June 2019^
  22. Medical cannabis product approved for epilepsy BBC News, 23 September 2019^