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Reports US

US stock market daily report (June 17, 2014, Tuesday)

June 18, 2014, Wednesday, 04:43 GMT | 23:43 EST | 08:13 IST | 10:43 SGT
Contributed by Millennium Traders

GW Pharmaceuticals plc (GWPH-Nasdaq) - a British biopharmaceutical company founded in 1998 - is conducting a range of studies on chemical cannabinoids found in marijuana. GW is growing cannabis under license at an undisclosed location in Britain. GW Pharma emphasizes its ability to extract key ingredients from cannabis for medical use, in the same way that pain-killing opioids have been developed from opium.

On Tuesday GW said its experimental product Epidiolex produced promising results in small children and young adults with treatment-resistant epilepsy. Epidiolex was tested in 27 patients with treatment-resistant epilepsy, in an open label study in the USA under an expanded access program, over a 12 week period. The end results showed a reduction in the frequency of seizures by over 50%. GW Pharma plans to begin a Phase II/III clinical trial during the second half of 2014. Chief Executive Officer for GW Pharma Justin Gover said he expects Epidiolex to be ready for submission to U.S. and European regulators in 2016. The U.S Food and Drug Administration have granted Epidiolex "orphan drug status" [ODS] which could make the path to market move a little easier. Additionally, ODS offers GW additional exclusivity. The designation reflects the unmet need for new approaches to help children with severe epilepsy syndromes such as Dravet and Lennox-Gastaut, where seizures often persist, despite high doses of multiple anti-epileptic drugs.

Gover said in an interview, "It has become a central part of our valuation - there is no doubt about that. That reflects a number of reasons: the fact there is so much interest among physicians and patients, the fact it is an orphan development program and the fact we own all the commercial rights worldwide."

Epidiolex is a strawberry-lime flavored syrup that contains the cannabinoid CBD and is given to patients at least twice a day. The medicine does not contain the psychoactive ingredient THC that makes marijuana smokers high.

In 11 countries, GW Pharma is already selling a synthetic THC as a treatment for Multiple Sclerosis spasticity - Sativex (nabiximols). Sativex is the first natural cannabis plant derivative to gain full market approval in any country. GW is also conducting a range of studies evaluating cannabinoids therapeutic value across cancer pain and diabetes. Sativex is given as an under-the-tongue spray and has received regulatory approval in an additional 13 countries. Sativex is in final-stage Phase III clinical development as a potential treatment of pain in people with advanced cancer.