GW Pharmaceuticals, the company developing a painkilling spray from cannabis, is braced to miss its end-of-year deadline for gaining approval to launch the drug.
The company is also growing less confident that the Government's medicines regulator will approve the drug, to be called Sativex, for all the uses it originally requested. At briefings with City analysts, GW has been saying it expects approval "from the end of the year", while its broker, Collins Stewart, has warned its clients that a decision could take until next autumn.
In an investment note, Collins Stewart analyst Jonathan Kwok wrote: "We expect to hear the final decision from the end of 2003 onwards."
With barely a month to go, sources at the MHRA believe it is unlikely an announcement would now be ready this year. 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. This would be a breakthrough treatment since neuropathic pain is viewed as difficult or impossible to treat.
People close to the company now believe the regulator, the MHRA, could reject the application to launch Sativex for neuropathic pain until more trial results are available later next year.
The likely delays will dismay investors who bought into a fund raising by the company after its interim results in June. At the time, the company said it was confident Sativex would be available on prescription in the UK by the end of 2003. Geoffrey Guy, the founder and chairman, sold £5m of shares at 200p at that time.
The company itself yesterday insisted nothing had changed since the start of the year. A spokesman said: "The process is continuing as expected. There is a month to go and we are confident of getting approval. We have always said the timing was going to be in the hands of the regulator".
The launch of Sativex will require a change in the law to reschedule cannabis, which the Government has promised on MHRA approval. GW shares were off 5p at 189.5p yesterday on fading hopes that the drug can be made available this year.Reuse content