UK Edition
Shares in GW Pharma rally after another promising epilepsy trial result
Shares in GW Pharmaceuticals soared by more than 10pc after the British biotech revealed yet another set of encouraging clinical trial results for its key childhood epilepsy drug, paving the way for regulatory approval.
The phase three study tested GW's cannabis-derived Epidiolex drug on children and adults with Lennox-Gastaut syndrome, a rare and severe form of epilepsy that begins in childhood. The results showed "high statistical significance", which means that the treatment was extremely effective in helping these patients, many of whom can suffer 80 serious seizures a month.
The trial supports two earlier late-stage clinical studies, one in children with Lennox-Gastaut and one in patients with Dravet syndrome, another form of epilepsy, both of which demonstrated equally promising results.
It puts GW Pharmaceuticals on track to file the drug with US regulators in the first half of 2017
"We are confident," said chief executive Justin Gover. "As a body of data we now have three positive phase three trial results. These are very robust findings and provide a compelling case to support the efficacy and safety of the drug with US regulators.
"The unusual feature of this programme is that we are developing the drug for two different types of epilepsy in parallel and we have agreement from FDA to make one submission for the drug in two different indications. That is unusual."
Epidiolex has the potential to be a breakthrough medication for children with rare forms of epilepsy, for whom there are no effective treatments.
Mr Gover hopes that the drug could be on the US market by the end of next year, with a European launch following shortly thereafter.
GW has been ramping up its commercial sales force in the US ahead of approval. It raised $300m in July from US investors and has roughly $500m in cash to help fund the launch. The biotech is also starting to put together a European commercial team.
Shares in GW Pharmaceuticals were priced at 773p by early afternoon.