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Cannabis-based medicine launched in UK
By John O’Doherty
Published: June 22 2010 04:46 | Last updated: June 22 2010 04:46
A cannabis-based medicine will go on sale across the UK this week, after British regulators gave their approval for the marketing of Sativex, a mouth spray therapy for multiple sclerosis patients.
“There are a number of firsts here,” said Dr Geoffrey Guy, chief executive of GW Pharmaceuticals, which makes Sativex.
“This is the first prescription cannabis-based medicine to be approved by a full pharmaceutical process anywhere in the world. It’s also the first plant-based medicine to be approved in modern times. It’s also the first of a range of products we have under development – all from the cannabis plant – and this approval provides global validation of our platform,” Dr Guy said.
Sativex is administered by a mouth spray device, roughly the size of an asthma inhaler, but the spray is directed under the tongue rather than into the lungs. A single device will deliver about 90 sprays and a typical patient would administer about eight sprays per day to relieve the shaking commonly experienced by MS patients.
The drug, which was launched on Monday and will be marketed by Bayer, has been available since 2005 to about 2,500 patients in the UK on a so-called “named patient” basis, where patients request the manufacturer for access to the drug.
The approval by the UK’s Medicines Health Regulatory Authority will allow doctors to prescribe Sativex directly without seeking named patient approval. It will cost roughly £11 ($16.2) a day and is likely to be reimbursed by most primary care trusts.
Analysts predict between £50m and £60m of peak annual sales for Sativex by 2015, with GW receiving between 20 and 30 per cent of that.
The approval of Sativex provides a boost to GW’s development programme to create other cannabis-based medicines. Trials are already underway on cannabis-based medicines to treat epilepsy and psychosis, and GW is seeking approval from US regulators for the marketing of Sativex as a treatment for cancer pain.
GW creates Sativex by processing cannabis plants it grows in secret facilities at an undisclosed location in the UK. Sativex cost £100m to develop and was based on selective breeding of two different types of cannabis plant that were acquired in 1998 from Dutch cannabis researchers Horta Pharm, which has a non-disclosed share in the success of Sativex.
“It’s wonderful news,” said David Watson, chief executive of Horta Pharm.
“I look forward to other cannabinoids being found out to be useful for other medical indications.”
Shares in GW Pharmaceuticals closed down 4.3 per cent or 6p at 135p on Monday.
http://www.ft.com/cms/s/0/1e5e5e06-7d2f-11df-8845-00144feabdc0.html