Drugs containing APIs derived from cannabis plants are a far cry from the non-clinical approach of marijuana dispensaries, says GWPharma, as France approves Sativex.
UK-based GWPharma has a number of drugs in its pipeline targeting diseases including schizophrenia, type 2 diabetes and epilepsy, and its lead molecule has European approval for the treatment of spasticity caused by multiple sclerosis.
This could describe the pipeline of any non-descript drugmaker except for one fact. All GWPharma’s drugs use derivatives of marijuana as active pharmaceutical ingredients (APIs), and last week France was the latest to country overcome the legality issues surrounding the plant and approve the oral spray Sativex.
Speaking to in-Pharmatechnologist.com, spokesman Mark Rogerson said GWPharma grows its own plants from a secure location in the South of England, extracts the API - known as a cannabinoid - and works through clinical trials.
“Sativex is very much an approved medicine - originally approved in the UK by the MHRA and then in other EU countries via the mutual recognition procedure,” he said. “It is quite distinct from crude herbal preparations.”
“There is a lot of talk in the US regarding dispensaries of medical marijuana but this has nothing to do with approved medicine and the clinical trial approach,” he added.
France’s health regulator, ANSM, approved the drug following a decree last June that allowed marketing approval of medicines containing cannabis extracts, though at the time the Ministry of Health warned the ruling would not decriminalize, or allow the therapeutic use of smoked cannabis, Lemonde reported .
The company grows 200 tonnes of cannabis plants a year and, despite the law, everything is above board due to an exclusive license from the UK’s Home Office allowing the company to work with the narcotic.
Produced in climate controlled and pressurised greenhouses, Rogerson explained that as with the sourcing and production of any API, there is a very clear audit trail ensuring no danger of contamination.
Sativex is about to commence Phase III trials in the US, and is also being trialed for use in cancer pain, both in the US and EU.
However, the plant itself contains around 80 cannabinoids and so far GWPharma is “still only scratching the surface,” Rogerson said, working with around twenty.
However, some of these cannabinoids are only found in tiny quantities so GWPharma has to breed the plant selectively, in order to extract sufficient quantities of ingredients, he added.