GW Pharmaceuticals, which makes drugs derived from cannabis, is due to have its first medicine on the market within months.
The British biotech company announced that regulators in the UK and Spain said that there were no quality, safety or efficacy issues with Sativex, its drug to treat spasticity in multiple sclerosis (MS).
Full approval is expected within three months. Sativex has been much delayed, but the news that it was finally close to approval sent GW's shares up 15 per cent to 115p.
Sativex is the first prescription medication in the world to be derived directly from the cannabis plant. Marijuana plants grown at secret locations in the English countryside provide its main ingredient. It is an oral spray which works by acting on the same parts of the brain that respond to smoking cannabis. Sativex works by protecting against damage to nerve cells and restoring normal functions to nerve cells that are already damaged.
Its approval will trigger a payment of £10 million to the company by Bayer, the pharmaceutical company which co-owns the drug in the UK, and £2.5 million from the Spanish partner Almirall.
The company is still 22 per cent owned by its founders Geoffrey Guy and Brian Whittle, who also founded Phytopharm.
GW will be able to expand into other European countries quickly under the mutual recognition procedure, in which countries recognise drugs that have been approved elsewhere more quickly. The company hopes that recognition will be confirmed in the first half of next year.
Justin Gover, managing director of GW, said: "This will also allow us to start thinking about expanding into markets beyond Europe."
Trials of Sativex to treat pain in cancer patients are taking place in the US.
Stefan Hamill, analyst at the stockbroker Execution Noble, said: "This is a watershed moment for GW where the intangible becomes tangible. The immediate benefit will be milestone payments and product royalties from launch, but the greater significance is validation of GW's cannabinoid focused business model."
NewsHawk: Ganjarden: 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: Times Online
Author: Catherine Boyle
Contact: Times Online
Copyright: 2010 Times Newspapers Ltd
Website: GW Pharmaceuticals expects approval for MS drug derived from cannabis
The British biotech company announced that regulators in the UK and Spain said that there were no quality, safety or efficacy issues with Sativex, its drug to treat spasticity in multiple sclerosis (MS).
Full approval is expected within three months. Sativex has been much delayed, but the news that it was finally close to approval sent GW's shares up 15 per cent to 115p.
Sativex is the first prescription medication in the world to be derived directly from the cannabis plant. Marijuana plants grown at secret locations in the English countryside provide its main ingredient. It is an oral spray which works by acting on the same parts of the brain that respond to smoking cannabis. Sativex works by protecting against damage to nerve cells and restoring normal functions to nerve cells that are already damaged.
Its approval will trigger a payment of £10 million to the company by Bayer, the pharmaceutical company which co-owns the drug in the UK, and £2.5 million from the Spanish partner Almirall.
The company is still 22 per cent owned by its founders Geoffrey Guy and Brian Whittle, who also founded Phytopharm.
GW will be able to expand into other European countries quickly under the mutual recognition procedure, in which countries recognise drugs that have been approved elsewhere more quickly. The company hopes that recognition will be confirmed in the first half of next year.
Justin Gover, managing director of GW, said: "This will also allow us to start thinking about expanding into markets beyond Europe."
Trials of Sativex to treat pain in cancer patients are taking place in the US.
Stefan Hamill, analyst at the stockbroker Execution Noble, said: "This is a watershed moment for GW where the intangible becomes tangible. The immediate benefit will be milestone payments and product royalties from launch, but the greater significance is validation of GW's cannabinoid focused business model."
NewsHawk: Ganjarden: 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: Times Online
Author: Catherine Boyle
Contact: Times Online
Copyright: 2010 Times Newspapers Ltd
Website: GW Pharmaceuticals expects approval for MS drug derived from cannabis
