GW Pharmaceuticals has launched Sativex – the world’s first cannabis-based prescription medicine – in the UK, where it is now available for the treatment of spasticity due to multiple sclerosis.
The move follows the green light from UK regulators last week, which approved the use of the oral spray Sativex (delta-9-tetrahydrocannabinol and cannabidiol) as an add-on treatment for improving the symptoms of moderate to severe spasticity due to MS, but only in patients who have not responded to other medication and who show a clinically significant improvement in symptoms during a trial run of therapy.
Around 100,000 people in the UK suffer from MS, and spasticity – which can cause uncontrollable stiffness, muscle tension and spasms – affects most patients at some point and can be very debilitating interfering with every day activities such as unscrewing bottle lids or getting out of a car.
The launch of Sativex marks the culmination of 11 years’ worth of research into the cannabinoid system by GW, which was founded with the primary goal of developing a medicine to address the unmet needs of people with MS, and gives patients access to a new treatment option to help improve symptoms of the disease.
The path to market for the drug has not been an altogether smooth one, but its efficacy is supported by strong clinical data, which show that around half of all people who add it to their existing medication find that it can provide relief from the debilitating symptoms of spasticity associated with MS.
The roll out of Sativex in the UK has triggered a hefty £10-million milestone to GW from country license-holder Bayer Schering Pharma, and should spur a new stream of revenue into the group’s coffers in the form or royalties on sales of the drug, all very positive developments for the group.
But shares in the company were actually on a downward trend following the drug’s launch after it emerged the treatment would cost is £125 per 10ml vial, which works out at about £11 a day per typical patient, potentially hindering its uptake and therefore market potential in an era of cost cutting and efficiency savings.
GW is, however, riding high on its achievement in getting its drug to market, which should now give the group a sizeable leg up on its long-planned transition from a late stage development company to a commercial pharmaceutical business.
Long awaited
Commenting on the launch of Sativex, Simon Gillespie, chief executive of the MS
Society, said the availability of any new MS medicine is “good news” and that Sativex has been long awaited. But “we hope that it will be made freely available on the NHS to anyone who might benefit from it”, he added.
Elsewhere, an approval for Sativex is expected in Spain imminently, which will release a further £2.5 million-milestone from licensee Almirall, and further submissions in other European countries are planned for the second half of the year under the mutual recognition procedure.
