GW Pharmaceuticals plc (GWPH)
Epilepsy is a general term for conditions with recurring seizures. A seizure is a temporary disturbance in brain function in which groups of nerve cells in the brain signal abnormally and excessively. There are many kinds of seizures, but all involve abnormal electrical activity in the brain that causes an involuntary change in body movement or function, sensation, awareness, or behavior.
Epilepsy is the 4th most common neurological problem ? only migraine, stroke and Alzheimer?s disease occurs more frequently.
Recently, the United States Food and Drug Administration (FDA) has granted Fast Track designation to GWPH's investigational cannabidiol product, Epidiolex(R), in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy for which there is currently no cure.
FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier.
In addition to Dravet syndrome, GWPH 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, GWPH 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.
Brokerage firm Piper Jaffray raised its price target on the company from $97.00 to $147.00 per share. According to Dr. Joshua Schimmer, a Piper Jaffray analyst, GWPH's Epidiolex is a highly attractive emerging therapy for epilepsy and the company's portfolio of cannabinoids will likely enable a group of products that can address the broader seizure market, including a subset of autism patients.
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.
More about GW Pharmaceuticals plc (GWPH) at www.gwpharm.com