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Cannabis Drug Set for End of Year Release

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A cannabis-based drug which relieves the symptoms of multiple sclerosis should be available on prescription by the end of the year, it was announced today.


GW Pharmaceuticals said Sativex, which contains extracts from whole cannabis plants, is on track for release subject to approval by the Medicines and Healthcare Products Regulatory Agency (MHRA).


Because it contains the class C drug, Sativex would also require a change in the law, but Home Secretary David Blunkett has indicated he would be willing to make an amendment if the drug was approved.


GW, based in Salisbury, grows 40,000 cannabis plants a year at a secret site.


The drug is administered as a spray in the mouth and works to alleviate pain and relax muscle spasms.


New clinical trials are about to start on the drug after it showed positive results in trials held in November.


It is also being tested for its effectiveness at treating cancer pain and neuropathic pain caused by spinal cord injury.


MS is the most common disabling neurological condition affecting young adults, with around 85,000 sufferers in the UK.


It results from damage to myelin - a protective sheath surrounding nerve fibres of the central nervous system - which then interferes with messages between the brain and other body parts.


GW, which has about 100 employees in the UK, has sold the marketing rights for Sativex to German healthcare giant Bayer.


It submitted its licence application to the MHRA in March and has indicated that if UK approval is received, it would look at entering the market in Canada, Australia and New Zealand.


Announcing its interim results today, GW said it made a net loss after tax of £6.7 million for the six months to March 31.


This compared with a loss of £5.3 million in the same period last year and the £5.9 million loss in the second half of the last financial year.


Research and development expenditure increased to £6.5 million from £5.1 million in the same period last year.


Executive chairman Dr Geoffrey Guy said: "GW's achievements over recent years provide a solid platform for growth.


"We are confident that GW is on track to secure regulatory approvals, commercial partnerships and launches for Sativex around the world."


Shares in the company stood 7p lower at 230.5p in afternoon trade.


Note: GW Pharmaceuticals says its cannabis-based treatment for multiple sclerosis is poised to become a prescription drug.



Source: Times Online (UK)

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