Products

* On October 22, 2014, GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the European Medicines Agency (EMA) has granted orphan designation to GW’s investigational product Epidiolex® (cannabidiol or CBD) in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. In addition to this orphan designation by the EMA, GW has been granted Fast Track designation by the FDA for Epidiolex in the treatment of Dravet syndrome as well as orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome (LGS).GW is about to commence a full clinical development program for Epidiolex in the treatment of both Dravet syndrome and LGS, working with leading pediatric epilepsy specialists across the U.S. The first Phase 2/3 clinical trial is due to commence in the coming weeks.

* On 2-4 September 2014, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending cannabidiol for designation as an orphan medical product for the treatment of Dravet syndrome.

* On June 6, 2014, GW Pharmaceuticals announced that the FDA has granted Fast Track designation to GW’s investigational cannabidiol (CBD) product, Epidiolex®, in the treatment of Dravet syndrome. GW has already opened an Investigational New Drug (IND) for Epidiolex® and the company is on track to commence a Phase 2/3 clinical trial in Dravet syndrome in the second half of 2014. In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome (LGS). Following receipt earlier in 2014 of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and expects to conduct two Phase 3 trials in LGS during 2015.