GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex®(cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added as an adjunct to the patient’s current treatment, achieved the primary endpoint of a significant reduction in the monthly frequency of drop seizures assessed over the entire 14-week treatment period compared with placebo (p=0.0135). This trial follows the announcement in March 2016 of positive results in a pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome. Epidiolex has Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LGS and Dravet syndrome.
“From a physician’s perspective, the positive outcome in this trial of Epidiolex in patients with Lennox-Gastaut syndrome is very exciting. Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies,” stated Linda Laux, MD, Director of the Comprehensive Epilepsy Center at Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of pediatrics, Northwestern University Feinberg School of Medicine and an investigator in the trial. “These data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile, which is consistent with my previous clinical experience with Epidiolex. I am excited about the prospect of Epidiolex being made available on prescription in the future and believe it has the potential to make an important difference to the lives of many patients.”
“We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome. We believe that this result further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies,” stated Justin Gover, GW’s Chief Executive Officer. “We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017.”
“Lennox-Gastaut syndrome is such a difficult form of epilepsy to treat. Additional safe and effective treatments are desperately needed for patients who continue to struggle with uncontrolled seizures,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “We are thrilled with these positive results, which offer much needed hope and promise to those living with this debilitating condition.” (Original Source)
Shares of GW Pharmaceuticals plc closed last Friday at $83.31, down $-5.83 or -6.54%. GWPH has a 1-year high of $131.25 and a 1-year low of $35.83. The stock’s 50-day moving average is $85.97 and its 200-day moving average is $69.24.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on June 21, Leerink Swann analyst Paul Matteis reiterated a Buy rating on GWPH, with a price target of $130, which represents a potential upside of 56.0% from where the stock is currently trading. Separately, on June 10, Morgan Stanley’s Andrew Berens reiterated a Buy rating on the stock and has a price target of $149.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Paul Matteis and Andrew Berens have a total average return of -15.9% and 6.5% respectively. Matteis has a success rate of 19.7% and is ranked #3816 out of 3980 analysts, while Berens has a success rate of 59.1% and is ranked #692.
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and Pipeline Research & Development. The Commercial segment promotes Sativex through strategic collaborations with major pharmaceutical companies for the currently approved indication of spasticity due to multiple sclerosis. The Sativex Research & Development segment seeks to maximize the potential of Sativex through the development of new indications. The Pipeline Research & Development segment seeks to develop cannabinoid medications other than Sativex, which are using the Group’s proprietary cannabinoid technology platform. GW Pharmaceuticals was founded by Geoffrey W. Guy and Brian Whittle in 1998 and is headquartered in Salisbury, the United Kingdom.