GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) has been running up the charts in recent months easily surpassing $100 a share and taking charge as the biggest pot stock on the markets. The stock recently got a boost after the Company announced Primary endpoint achieved in both Epidiolex doses with high statistical significance compared to placebo.
GWPH nearly tripled in March after the Company announced positive Phase 3 trial data for its drug Epidiolex, for the treatment of Dravet syndrome. This is big news 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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In June 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.
On September 26 GWPH announced positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex(R) (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance.
During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).
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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.