GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) skyrocketed on Monday after the Company announced positive Phase 3 trial data for its drug Epidiolex, for the treatment of Dravet syndrome.
This is huge news indeed for GW as the market for Epidiolex could exceed $1 billion. It also shows that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications. GW saw its market valuation more than double from about $900 million to $1.8 billion on the news which has ignited the entire pot stock sector.
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex(R), which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States.
GW Pharmaceuticals was founded by Doctors Geoffrey Guy and Brian Whittle in 1998 when 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.
The Company first developed Nabiximols tradename Sativex (from two unknown Cannabis strains, and is extracted with ethanol and carbon dioxide) a botanical drug, 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.
In 2011, GW Pharmaceuticals concluded a partnership with Bayer for the distribution of Sativex in the UK and have an estimated annual production of 100 tons of medicinal cannabis since 2012.
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. GW also received fast track designation from the US FDA for use of the drug candidate to treat newborns with epilepsy.
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On Monday GW announced positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex(R) (cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo .
Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the U.S.
GW’s study on Epidiolex for the treatment of Dravet syndrome is the first of four final-stage Phase III epilepsy trials, with results expected this year. The drugmaker hopes the study will confirm the therapeutic benefits of cannabinoids, the active ingredients found in marijuana.
GW CEO Justin Gover said “The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families.”
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Currently exploding up the charts GWPH has seen its market valuation more than double after the Company announced positive test results for its experimental medical marijuana drug Epidiolex for the treatment of Dravet syndrome that analysts say could eventually propel the drug’s sales above $1 billion. The news is also a game changer for the Company as it proves that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications. We will be updating on GWPH when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with GWPH.
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Disclosure: we hold no position in GWPH either long or short and we have not been compensated for this article.