Sat, 1 May 2004
GW Pharmaceuticals, the company developing a painkilling spray from cannabis, has warned that regulatory concerns will delay the launch of the drug for a second time.
The UK authorities have demanded more information on how the drug is formulated and on how safe and effective it might be to treat the symptoms of multiple sclerosis and the pain caused by nerve damage.
GW's shares lost 25 per cent of their value on the latest delay, ending at 133.5p.
Geoffrey Guy, GW's founder and chairman, said there was no prospect of the product, to be called Sativex, being approved by the end of June as promised at the start of this year. At the time of a fund raising and directors' share sales last June, GW was promising the drug would be available on the National Health Service by the end of 2003.
Dr Guy said: "We haven't changed our view that the product is approvable, but clearly we got the timing wrong - as have all the people involved."
The Medicines and Healthcare Products Regulatory Authority (MHRA) has had a dossier of scientific information on Sativex, including the results of several human trials, for more than a year but has repeatedly expressed dissatisfaction with the data. GW first admitted the authority had demanded extra information in January.
"Their questions covered all parts of the dossier," said Dr Guy. "In January we had just submitted responses and large numbers of those original issues have been resolved, but they will keep asking questions until they are fully comfortable with this new style of dossier."
The Government has been keen to promote a medicinal alternative to smoked cannabis and GW believes it has overcome problems of how to ensure a plant-based drug contains the same amount of active ingredient in each dose, and of ensuring that patients take the right dose.
Multiple sclerosis patient groups have long campaigned to be allowed
to use a cannabis drug to relieve their symptoms, and GW believes it has
trial data which shows Sativex is an effective treatment for muscle stiffness
and bladder problems. It has also requested that it be approved for use
to relieve neuropathic pain, pain caused by a diseased or damaged nervous
system. Dr Guy promised an update on progress next month, which could reveal
whether results from the latest human trials, due to complete over the
summer, will be needed to satisfy the MHRA.
Copyright © 2004, Independent Digital (UK) Ltd