GREENWICH BIOSCIENCES, INC.
CARLSBAD, CA

, about joining the partnership. Digital Health Solutions commercializes software called Child Health Improvement through Computer Automation, or CHICA, to help physicians identify pediatric patients' problems earlier. The company licenses the software through the IU Innovation and Commercialization Office. "Through a questionnaire administered on an electronic tablet, CHICA captures patient-reported data and provides clinical advice to the physician through the electronic health record," Downs said. "The goal of the collaboration between Digital Health Solutions, CNF and Greenwich Biosciences is to build into CHICA the ability to identify children at risk for SUDEP and alert the pediatrician that counseling is needed. We will test the system in five clinics in the The research collaboration contract between Greenwich Biosciences, CNF and Digital Health Solutions was signed in December. While the SUDEP module is being created, CNF will integrate child neurology expertise in the development of the SUDEP module as well as provide patient education materials on SUDEP and opportunities for caregiver peer support. About Greenwich Biosciences Greenwich Biosciences is committed to improving the lives of patients by developing and commercializing cannabinoid pharmaceuticals for rare and catastrophic diseases with limited or no FDA-approved treatments. Greenwich, along with its parent company GW Pharmaceuticals plc, is currently advancing an orphan drug development program in certain childhood-onset epilepsy syndromes with its investigational drug, Epidiolex® (cannabidiol), for which a New Drug Application is currently under priority review by the U.S. Food and Drug Administration. For more information, visit "The publication of these positive results is an exciting milestone for the LGS community and we are encouraged that a new treatment option could soon be available," said Christina SanInocencio, executive director of the Lennox-Gastaut Syndrome Foundation. "Additional treatment options are desperately needed for patients who continue to struggle with uncontrolled seizures and these results offer much needed hope to those living with this debilitating condition." "LGS is one of the most difficult types of epilepsy to treat and the majority of patients do not have an adequate response to existing therapies," said Elizabeth Thiele, MD, PhD, director of pediatric epilepsy at Massachusetts General Hospital, professor of Neurology at Harvard Medical School and lead author of the study publication. “These results show that Epidiolex may provide clinically meaningful benefits for patients with LGS.” Over the 14-week treatment period (two-week dose escalation period followed by 12 weeks of maintenance), patients taking Epidiolex had a significantly greater median reduction in drop seizures compared to placebo (44 percent vs. 22 percent; p=0.0135), the study’s primary endpoint. Sensitivity analyses confirmed that the treatment effect of CBD was established during the first month of treatment and was sustained over the entire treatment period. “Uncontrolled seizures significantly impact the lives of patients and their families and there is a tremendous need for new options in difficult-to-treat epilepsies such as LGS,” said Philip Gattone, president and CEO, Epilepsy Foundation. “This randomized, controlled clinical study provides positive evidence of the potential role of cannabidiol in reducing seizures and we are excited about the possibility of a new treatment option for LGS.” Epidiolex, GW's lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome, which has been assigned a goal date of 27 June 2018 and, if approved, the medicine is expected to be available by prescription in the second half of 2018. GW has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in December 2017 with an expected decision date in early 2019. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms. About GW Pharmaceuticals plc and Greenwich Biosciences Founded in 1998, GW 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, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for gliobastoma, schizophrenia and epilepsy. For further information, please visit This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Epidiolex