On April 19th an FDA advisory committee voted unanimously to recommend approval of the first prescription cannabidiol medicine — to treat rare and severe forms of epilepsy. The drug is known as Epidiolex. The company behind Epidiolex is GW Pharmaceuticals.
Based in the UK, GW is developing several cannabis based products for a number of different conditions. In addition to the epilepsy indication, Epidiolex is in Ph III testing for Tuberous Sclerosis Complex (TSC) and expects to commence a Phase 3 trial in Infantile Spasms (IS). Their product, Sativex, is approved to treat spasticity in MS patients in 21 countries. Sativex is in Ph III trials in the U. S.
Additionally, GW has three other products in various stages of development to treat diseases including: epilepsy, autism spectrum disorder, neonatal hypoxic-ischemic encephalopathy, glioblastoma, and schizophrenia. The PDUFA goal date for completion of the FDA review of Epidiolex is 6/27/18.
The company was founded in the UK in 1998 by two biotech entrepreneurs, Dr. Geoffrey Guy and Dr. Brian Whittle. The doctors worked closely with both the UK Home Office and the UK’s medicines regulatory authority on establishing necessary licenses and procedures so as to facilitate the progress of GW’s cannabinoid research program.
GW currently trades on NASDAQ under the symbol GWPH. The stock has risen steadily in the last month from ending at 105.86 on April 2 to 132.80 as of this writing.
As of 9/30/17 GW financials showed $323 million in cash and cash equivalents and $446 million in total assets. Total current liabilities were $49 million and total liabilities were $73 million.
