GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the Company has selected infantile spasms (IS) as the fourth target indication for its Epidiolex orphan pediatric epilepsy development program. In addition, the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Epidiolex (cannabidiol or CBD) for the treatment of IS. GW expects to commence a two-part pivotal Phase 3 study in the fourth quarter of 2016.
Epidiolex is already being developed in three other orphan indications within the field of pediatric epilepsy – Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). In March 2016, GW announced positive results from the first Phase 3 trial in Dravet syndrome. Results of the first Phase 3 trial in LGS are expected in June 2016.
“We are pleased to add infantile spasms as a fourth target indication for Epidiolex, demonstrating GW’s ongoing commitment to addressing the significant unmet medical need within the field of pediatric epilepsy,” stated Justin Gover, CEO of GW Pharmaceuticals . “Currently, there are limited treatment options for children suffering from infantile spasms and outcomes for patients with the disorder include higher mortality, ongoing development of additional seizure disorders as the patient matures, and often severe cognitive and developmental delay.”
An infantile spasm is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. The onset of infantile spasms usually occur in the first year of life, typically between 4-8 months of age. The condition constitutes 2 percent of childhood epilepsies and 25 percent of epilepsies with onset in the first year of life. There are approximately 2,000 to 4,000 new cases in the United States each year. The long-term overall prognosis for patients with infantile spasms is poor. Cognitive and developmental delay is severe in 70 percent of patients, often with psychiatric problems such as autistic features or hyperactivity. It has been found that 50-70 percent of patients develop other seizure types and that 18 to 50 percent will develop LGS or some other form of symptomatic generalized epilepsy. (Original Source)
Shares of GW Pharmaceuticals are up nearly 4% to $92.00 in pre-market trading. GWPH has a 1-year high of $133.98 and a 1-year low of $35.83. The stock’s 50-day moving average is $84.92 and its 200-day moving average is $69.13.
On the ratings front, GWPH has been the subject of a number of recent research reports. In a report issued on June 10, Morgan Stanley analyst Andrew Berens reiterated a Buy rating on GWPH, with a price target of $149, which represents a potential upside of 68.5% from where the stock is currently trading. Separately, on May 5, Leerink Swann’s Paul Matteis maintained a Buy rating on the stock and has a price target of $130.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Berens and Paul Matteis have a total average return of 7.1% and -13.8% respectively. Berens has a success rate of 59.1% and is ranked #703 out of 3977 analysts, while Matteis has a success rate of 31.7% and is ranked #3781.
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.