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Cannabis-based epilepsy drug to be first to win US approval Sarah Neville Financial Times Sunday 24 Jun 2018 Please use the sharing tools found via the email icon at the top of articles. Copying articles to share with others is a breach of FT.com T&Cs and Copyright Policy. Email licensing@ft.com to buy additional rights. Subscribers may share up to 10 or 20 articles per month using the gift article service. More information can be found at https://www.ft.com/tour. https://www.ft.com/content/fa17d0e4-7600-11e8-a8c4-408cfba4327c A drug to treat childhood epilepsy is this week expected to become the first medicine derived from cannabis to be approved for sale in the US, giving a UK biotech company a head start in a market potentially worth billions of dollars. GW Pharmaceuticals has raised $1bn from US healthcare funds during the past five years to develop Epidiolex, which has been proven in trials to reduce seizures in children. Justin Gover, chief executive, said the Food and Drug Administration was expected to approve the treatment for two types of childhood onset epilepsy, perhaps as soon as Wednesday, paving the way for the drug to be launched in the US in the autumn. He would not speculate on the level of likely sales but analysts have suggested Epidiolex will become a blockbuster drug — defined as a medicine that earns its manufacturer more than $1bn a year. The European Medicines Agency is expected to approve the drug early next year, and Mr Gover said he hoped that the National Institute for Health and Care Excellence, which assesses the cost-effectiveness of drugs in the UK, would also agree the drug should be made available on the taxpayer-funded National Health Service. GW was founded 20 years ago to capitalise on the medical properties of cannabis and in 2010 it launched Sativex, to treat the symptoms of multiple sclerosis. The drug is available in almost 30 countries, but not in the US, into which the company is now hoping to build a substantial bridgehead with Epidiolex. It hopes eventually to launch Sativex there, too. The use of cannabis as a treatment for epilepsy has come to the fore in the UK in the past week, sparked by the case of Billy Caldwell, a 12-year-old epilepsy sufferer. His mother, Charlotte, has treated his seizures with cannabis oil, which is illegal in the UK, and his condition reportedly deteriorated after his supply was confiscated when they re-entered the country at London’s Heathrow airport. Later, Sajid Javid, the UK home secretary, announced a review into the use of medicinal cannabis. Mr Gover said: “What we’re offering?.?.?.?is a bona fide prescription medicine which actually has been characterised in terms of its side effects, its efficacy, standardised manufacturing and so on. Everything that you know to be important and true for any medication that is available from a doctor will apply to this drug.” A key breakthrough for the company had been its decision to list on Nasdaq, after more than a decade on the junior investment market Aim in London. This move has enabled it to tap into the more plentiful supply of risk capital available in the US. GW’s share price had been “$8.90 when we listed on Nasdaq, in May 2013, it’s about $150 today”, he said. Its most recent fundraising took place in December when it secured $300m from US investors. The company is currently worth about $4.5bn, he said. While GW has yet to hold detailed discussions with payers — such as insurers and pharmacy benefit managers — in the US about reimbursement for Epidiolex, Mr Gover said that across the political and social spectrum there was a recognition that “the cannabis plant could be the basis of real medical value”. GW is now exploring whether its cannabinoid-based treatments can treat other diseases. A phase two trial that the company has conducted showed promise in increasing survival in an aggressive form of brain cancer, glioblastoma. It is also about to start trials in the area of autism; Mr Gover cited “quite a lot of evidence?.?.?.?that cannabinoids affect behaviour and cognitive function”. It had taken the company “an awful long time to get to where we are?.?.?.?but we’ve really built a huge lead”, he said. Mr Gover added: “We’re the world-leaders in cannabinoid science, and I think we expect to stay there for quite some time.” https://www.ft.com/content/fa17d0e4-7600-11e8-a8c4-408cfba4327c
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