GW Pharmaceuticals, the UK biotech company, is on the verge of receiving approval from the US Food and Drug Administration for Epidiolex, its cannabis-based treatment for severe childhood epilepsy. GW moved to the Nasdaq stock exchange in the USA in 2016, de-listing from London’s alternative AIM exchange because it is developing cannabis-based drugs which US capital markets are more open to. Cannabis use for medical purposes is legal in 26 US states and Washington DC. In nine states and DC, recreational use of cannabis is also permitted.
GW’s research and manufacturing base is still in Cambridge and the biotech ambassador has had a license to grow cannabis in England for 20 years. The UK is, ironically, the largest exporter of medical cannabis in the world despite domestic laws around the plant remaining strict and thus far resistant to modernisation. However, because Epidiolex is cannabis-based but includes other active ingredients the GW still hopes to receive permission to also launch the medicine in the UK next year. Europe-wide licensing is expected around the same time.
Epidiolex is expected to be approved within a month in the US and is a shot in the arm for GW after recent setbacks around clinical trials for another medicine, Sativex, which treats symptoms of multiple sclerosis. Other cannabis-based drugs in the GW pipeline include medicines to treat cancer and autism but delays in managing to bring a major product to market has recently seen investor enthusiasm for the company wane. However, impending approval for Epidiolex has driven GW Pharmaceuticals’ share price to new record highs over the past month. The company’s market cap is now approaching $4.5 billion and individual shares have reached $160 from just over $130 at the beginning of the year.
GW’s treatments are based on cannabidiol and do not contain any THC, the compound that provides the ‘high’ associated with recreational use of the drug. It is only over recent decades that cannabis has been classified as controlled substance. While restrictions were in place earlier, it was criminalised by the FDA in 1970 as a narcotic with ‘no accepted medical use’. That status has repeatedly been challenged since but it is only recently that the latest biotechnology has started to prove in clinical trials the potentially wide ranging therapeutic benefits.
GW chief executive Justin Glover responded to the welcome news that Epidiolex is close to sealing approval by asserting the ‘serious science’ behind what his company is working on. He went on to explain:
“The cannabis plant was originally a medicinal plant. It was only in the later part of 20th century that cannabis became known for its recreational properties. What we are doing is not trying to go backwards in history, but trying to recognise that this plant seems to have molecules in it which really might help across a number of diseases.”