Saturday, September 15, 2012

UK Company Develops Cannabinoid Medicine with International Acceptance

Sativex is a cannabinoid medicine for the treatment of spasticity due to multiple sclerosis which is also in development in cancer pain and neuropathic pain of various origins...
Now approved in the UK, Spain, Germany, Denmark, the Czech Republic, Sweden, New Zealand and Canada.

GW Pharmaceuticals, the developer of Sativex, was founded in 1998 and listed on AIM, a market of the London Stock Exchange, in June 2001.

GW occupies a world leading position in cannabinoid science and has developed an extensive international network of the most prominent scientists in the field. In mid 2007, GW’s early cannabinoid research activities were significantly expanded through the establishment of a global cannabinoid research agreement with Otsuka. Under this collaboration, GW and Otsuka are researching novel cannabinoids as potential treatments in the fields of Central Nervous System (CNS) disorders and oncology. In addition, GW has an in-house programme researching cannabinoids in the field of type 2 diabetes and related metabolic disorders. As part of this programme, GW set up in 2009 the GW Metabolic Research Laboratory at the University of Buckingham.

There are over 60 cannabinoid compounds identified to date. GW is researching a large number of cannabinoids, each of which has different effects and applications.

GW was co-founded in 1998 by Dr Geoffrey Guy and Dr Brian Whittle, two well-known entrepreneurs in the UK biotech sector. In setting up GW, Dr Guy and Dr Whittle worked closely with both the UK Home Office and the UK’s medicines regulatory authority on establishing necessary licences and procedures so as to facilitate the progress of GW’s cannabinoid research programme. Dr Guy and Dr Whittle also worked with various branches of UK law enforcement to ensure the strictest security surrounds any work conducted involving the company’s cannabis plant material.

In just one year following its inception, GW commenced its first clinical trials evaluating different cannabinoid formulations as potential treatments in the fields of MS and pain. Rapidly, GW focused on the development of Sativex, an oromucosal spray with two principal cannabinoid components, Cannabidiol (CBD) and Delta-9 Tetrahydrocannabinol (THC). Since 1999, the safety and efficacy of Sativex has been studied in over 20 randomized placebo-controlled trials including over 3,000 patients.

In 2003, GW entered into its first pharmaceutical licence agreement with Bayer Healthcare AG for the UK marketing rights to Sativex. This agreement was expanded to include Canada later that year. In 2005, GW and Almirall signed a licence agreement granting Almirall exclusive marketing rights to Sativex in Europe (ex-UK). In 2007, GW granted Otsuka the US development and marketing rights to the product.

Sativex was first approved in Canada in 2005 under Health Canada’s Notice of Compliance with conditions (NOC/c) policy for the treatment of neuropathic pain in MS. This approval was extended to cancer pain in 2007.

In May 2009, Sativex was the subject of a regulatory submission in the UK and Spain for the treatment of MS spasticity and was approved in both countries in summer 2010. The UK launch took place in June 2010. Following the achievement of national remibursement status in Spain in February 2011, Sativex was launched in that country in March 2011.

In March 2011, Sativex successfully completed the European Mutual Recognition Procedure (MRP) with the regulatory authorities in six member states(Germany, Italy, Denmark, Sweden, Austria and the Czech Republic) confirming that Sativex meets their requirements for approval. The next step in the regulatory process involves separate national phases in each country to finalize local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, they expect each country to then issue a national marketing authorization. They anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.

In the United States, the lead indication for Sativex is cancer pain. Following positive data reported in March 2010 from a Phase IIb study, a Phase III clinical program is now underway.

In only the very recent past, a natural cannabinoid receptor system in the human body has been discovered. This has sparked renewed interest in the therapeutic potential of cannabinoids by identifying important new targets for drugs.