Green light
Approval for US children to receive marijuana drug draws closer
A CANNABIS-DERIVED treatment for severe epilepsy in children, which was discovered and developed in the UK, will become the first medication of its kind to gain regulatory approval when US authorities give it the green light on Wednesday.
Epidiolex is the brainchild of Dr Geoffrey Guy, the British physician, who founded GW Pharmaceuticals, the publicly-listed company behind the drug, in 1998. He wants to develop the compounds found in the cannabis plant into regulated medications.
The drug made from the marijuana plant aced final stage clinical trials two years ago and was so effective in helping children with Lennox-gastaut syndrome and Dravet syndrome – two severe forms of epilepsy – that GW Pharmaceuticals made it available to patients for free on “compassionate use” grounds.
There are 50 children in the UK currently taking the unregulated drug on this basis. Justin Gover, who has been the company’s chief executive since it was founded, said Epidiolex is the first of a new type of anti-epileptic drugs to hit the market. “There is a real lack of treatment options for these children, whose epilepsy is resistant to existing medications,” he said. “They have 75 severe drop seizures a month and Epidiolex can reduce that by 40pc to 50pc.”
Analysts expect Epidiolex to become a blockbuster drug, which means annual sales would reach at least $1bn (£750m). There are roughly 40,000 children in the US who suffer from Dravet and Lennox-gastaut epilepsy. Patients in the US will get access to the approved drug in the autumn, while European regulators are expected to approve Epidiolex early next year.
Medicinal cannabis use has made headlines because of the case of 12-year-old epileptic Billy Caldwell, whose cannabis oil was confiscated at Heathrow Airport, but then returned to him after the Government granted an exemption on medical grounds. But unlike the sort of cannabis oil Billy is taking, which is a controlled substance that induces a high, Epidiolex is a processed pharmaceutical medication derived from CBD, a non-hallucinogenic compound found in cannabis. “There is a difference between a regulated medicine that has been studied and unregulated oils that have not been studied,” Mr Gover said.
“Epidiolex is being used on compassionate grounds for children with all forms of severe epilepsy. If his physician felt it appropriate to contact us, I would certainly consider offering it to Billy free of charge.”
Mr Gover said that, with more than 100 different compounds found in the cannabis plant, the opportunity to discover other life-changing drugs was big. GW is currently looking at developing treatments for autism, psychiatric disease and cancer.
“This is the beginning of a new chapter of research into cannabinoids,” Mr Gover said. “I am proud of what we have achieved because this is a tough sector. It is not an easy road with inevitable bumps along the way. But my main source of pride is to have developed a medication that makes a difference to people’s lives. There is no greater satisfaction than that.”
Getting GW to where it is now – a darling of the biotech market – has certainly not been easy. Mr Gover’s ability to attract investors in 1998 was tricky. Not only were they wary of the inherent risk involved with biotech startups, but they were suspicious of how cannabis could be turned into a regulated drug.
“In the early days we found it difficult. There was a bit of scepticism,” Mr Gover said. “It has been somewhat of different experience in the last few years.” Indeed, the company’s share price has soared. While trading on London’s junior Aim market between 2001 and 2016, the share price more than quadrupled in value.
Since it listed on the NASDAQ in 2013, the price has risen from $8.90 to its current value of $150. In the last five years GW has raised $5bn.
So will GW be willing to sell out if a wealthy buyer comes knocking? “We are very comfortable going it alone,” said Mr Gover.
“We built a commercial team to launch the drug and will be making a success on our own.”
‘My main source of pride is to have developed a medication that makes a difference to people’s lives ’