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===Epidiolex=== |
===Epidiolex=== |
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In 2015 GW Pharmaceutical initiated [[Phase 3 clinical trial]]s of an investigational [[cannabidiol]], Epidiolex, for treatment of two [[rare disease|orphan conditions]] in children – [[Dravet syndrome|Dravet]] and [[Lennox–Gastaut syndrome|Lennox-Gastaut]] syndromes.<ref>{{Cite web|url = http://medsnews.com/health/therapeutic-cannabis-for-children-a-possible-new-treatment-for-epilepsy/|title = Therapeutic Cannabis for children – a possible new treatment for epilepsy|date = 9 December 2015|access-date = 3 February 2016|website = Meds News|publisher = |last = Butticè|first = Claudio}}</ref> GW also received [[FDA Fast Track Development Program|fast track]] designation from the US FDA for use of the drug candidate to treat newborns with epilepsy.<ref>Tony Quested for Business Weekly. 6 August 2015 [http://www.businessweekly.co.uk/news/local-sharewatch/fda-backs-cannabis-based-medicine-danger-newborns FDA backs cannabis-based medicine for in-danger newborns]</ref> |
In 2015 GW Pharmaceutical initiated [[Phase 3 clinical trial]]s of an investigational [[cannabidiol]], Epidiolex, for treatment of two [[rare disease|orphan conditions]] in children – [[Dravet syndrome|Dravet]] and [[Lennox–Gastaut syndrome|Lennox-Gastaut]] syndromes.<ref>{{Cite web|url = http://medsnews.com/health/therapeutic-cannabis-for-children-a-possible-new-treatment-for-epilepsy/|title = Therapeutic Cannabis for children – a possible new treatment for epilepsy|date = 9 December 2015|access-date = 3 February 2016|website = Meds News|publisher = |last = Butticè|first = Claudio}}</ref> GW also received [[FDA Fast Track Development Program|fast track]] designation from the US FDA for use of the drug candidate to treat newborns with epilepsy.<ref>Tony Quested for Business Weekly. 6 August 2015 [http://www.businessweekly.co.uk/news/local-sharewatch/fda-backs-cannabis-based-medicine-danger-newborns FDA backs cannabis-based medicine for in-danger newborns]</ref> Early indications from the FDA indicate they are impressed with the risk-benefit profile of the product but concerns remain about the increased risk of liver damage.<ref>{{Cite web|url=https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM604736.pdf|title=FDA Briefing Document - Peripheral and Central Nervous System Drugs - Advisory Committee Meeting|last=|first=|date=|website=|archive-url=|archive-date=|dead-url=|access-date=19 April 2018}}</ref> The PDUFA date for Epidiolex is 27 June 2018.<ref>{{Cite news|url=http://www.globenewswire.com/news-release/2017/12/28/1275682/0/en/GW-Pharmaceuticals-Announces-Acceptance-of-NDA-Filing-for-Epidiolex-cannabidiol-in-the-treatment-of-Lennox-Gastaut-syndrome-and-Dravet-syndrome.html|title=GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome|last=plc|first=GW Pharmaceuticals|work=GlobeNewswire News Room|access-date=2018-04-19|language=en-US}}</ref> |
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==See also== |
==See also== |
Revision as of 20:25, 19 April 2018
Company type | Public Limited Company |
---|---|
Nasdaq: GWPH | |
Industry | Pharmaceutical |
Founded | 1998 |
Founder | Geoffrey Guy and Brian Whittle |
Headquarters | Cambridge, United Kingdom[1] |
Key people | Justin Gover (CEO)[2] |
Products | Sativex® |
Revenue | $33.8 million (2001)[3] |
Divisions | Biotechnology |
Website | www |
GW Pharmaceuticals is a British biopharmaceutical company known for its multiple sclerosis treatment product nabiximols (brand name, Sativex). Sativex is the first natural cannabis plant derivative to gain market approval in any country.[4] Another cannabis-based product, Epidiolex, for treatment of epilepsy, underwent phase 3 clinical trials in 2015.[5][6]
History
Background
Doctors Geoffrey Guy and Brian Whittle founded GW Pharmaceuticals in 1998. That year they obtained a cultivation license from the United Kingdom Home Office and the MHRA, allowing GW Pharmaceuticals to cultivate cannabis from seeds and clones to conduct scientific research concerning the medicinal uses of the plant.[7][8]
HortaPharm
In July 1998, GW Pharmaceuticals collaborated with HortaPharm B.V., a cannabis research and development corporation based in Amsterdam, The Netherlands,[9] founded by two expert horticulturists from California,[10] Robert Connell Clarke[11] and David Paul Watson, also known as 'Sam the Skunkman'. [12] HortaPharm grew medicinal strains for the Dutch government.[13][14] [15] [16]
Marketed 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.[17]
Nabiximols is made with two unknown Cannabis strains, and is extracted with ethanol and carbon dioxide.[18][19]
In 2011, GW Pharmaceuticals concluded a partnership with Bayer for the distribution of Sativex in the UK,[20] and have an estimated annual production of 100 tons of medicinal cannabis since 2012.[21]
Products in development
Epidiolex
In 2015 GW Pharmaceutical initiated Phase 3 clinical trials of an investigational cannabidiol, Epidiolex, for treatment of two orphan conditions in children – Dravet and Lennox-Gastaut syndromes.[22] GW also received fast track designation from the US FDA for use of the drug candidate to treat newborns with epilepsy.[23] Early indications from the FDA indicate they are impressed with the risk-benefit profile of the product but concerns remain about the increased risk of liver damage.[24] The PDUFA date for Epidiolex is 27 June 2018.[25]
See also
References
- ^ "GW Pharmaceuticals Ltd". 17 August 2017.
- ^ https://www.theguardian.com/business/2011/apr/17/gw-pharmaceuticals-justin-gover-cannabis-sativex-multiple-sclerosis?INTCMP=SRCH The Observer, Sunday 17 April 2011)
- ^ "Prices and markets Stocks of GW PHARM". Londonstockexchange.com. 28 June 2001.
- ^ Elizabeth Landau (21 June 2010). "World's first fully approved cannabis drug on sale in UK". Thechart.blogs.cnn.com.
- ^ Ward, Andrew (9 January 2014). "GW raises nearly $90m to develop childhood epilepsy treatment". Financial Times. Retrieved 20 January 2014.
- ^ plc, GW Pharmaceuticals. "GW Pharmaceuticals Initiates Second Phase 3 Pivotal Study of Epidiolex(R) (CBD) in Lennox-Gastaut Syndrome". Retrieved 20 September 2015.
- ^ Pete Brady (25 April 2003). "GW Pharm responds to CC". Cannabisculture.com. Archived from the original on 12 November 2013.
{{cite web}}
: Unknown parameter|deadurl=
ignored (|url-status=
suggested) (help) - ^ Cannabis in Medical Practice: A Legal, Historical, and Pharmacological Overview of the Therapeutic Use of Marijuana (Google eBook) – via Google Books.
- ^ "The Inheritance of Chemical Phenotype in Cannabis sativa L.(HortaPharm B.V., 1075 VS, Amsterdam, The Netherlands and Instituto Sperimentale per le Colture Industriali, 40128 Bologna, Italy)". Genetics.org. 1 January 2003.
- ^ "sam-the-skunkman [Four Twenty Wiki]". Fourtwentywiki.com. 16 August 2011.
- ^ "inauthor:"Robert Connell Clarke" – Google Search".
- ^ "(DAVID A WATSON 49366-018 55-White-M UNKNOWN NOT IN BOP CUSTODY) david watson aka SKUNKMAN". Bop.gov.
- ^ Marks, MD; Tian, L; Wenger, JP; et al. (2009). "Seeds from the marijuana cultivar Skunk no. 1 were provided by HortaPharm BV (Amsterdam, The Netherlands) and imported under a US Drug Enforcement Administration (DEA) permit to a registered controlled substance research facility" (PDF). J. Exp. Bot. 60: 3715–26. doi:10.1093/jxb/erp210. PMC 2736886. PMID 19581347.
- ^ "Details released of collaboration between GW Pharmaceuticals and HortaPharm medicinal cannabis". Gwpharm.com.
- ^ Breen, Bill (1 February 2004). "The Cannabis Conundrum". Fastcompany.com.
- ^ Breen, Bill (1 February 2004). "Dr. Dope's Connection". Fastcompany.com.
- ^ UK Medicines Online Nabiximols Page accessed 3 February 2016
- ^ "Extraction of pharmaceutically active components from plant materials". Patentstorm.us.
- ^ "Is Big Pharma set to corner the American market on medical marijuana?". Americanindependent.com. 25 April 2011. Archived from the original on 22 July 2012.
{{cite web}}
: Unknown parameter|deadurl=
ignored (|url-status=
suggested) (help) - ^ "GWPharma – GW and Bayer Announce Marketing Agreement on Pioneering New Cannabis-based Treatment". Gwpharm.com. 30 September 2004.
- ^ "Medical Cannabis Strains – Geoffrey Guy, MD (GW Pharmaceuticals, UK (Conference)". Youtube.com. 23 February 2010.
- ^ Butticè, Claudio (9 December 2015). "Therapeutic Cannabis for children – a possible new treatment for epilepsy". Meds News. Retrieved 3 February 2016.
- ^ Tony Quested for Business Weekly. 6 August 2015 FDA backs cannabis-based medicine for in-danger newborns
- ^ "FDA Briefing Document - Peripheral and Central Nervous System Drugs - Advisory Committee Meeting" (PDF). Retrieved 19 April 2018.
{{cite web}}
: Cite has empty unknown parameter:|dead-url=
(help) - ^ plc, GW Pharmaceuticals. "GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome". GlobeNewswire News Room. Retrieved 19 April 2018.