European marketing deal signed for Sativex
Following the signing of an exclusive agreement with GW Pharmaceuticals, Almirall Prodesfarma is to market Sativex, a cannabis-based drug, in Europe but not in the UK, where the drug is already marketed by Bayer.
Following the signing of an exclusive agreement with GW Pharmaceuticals, Almirall Prodesfarma is to market Sativex, a cannabis-based drug, in Europe but not in the UK, where the drug is already marketed by Bayer.
Sativex - currently in Phase III trials for the treatment of spasticity and neuropathic pain in Multiple Sclerosis, peripheral and general neuropathic pain and cancer pain - is a prescription product containing the active cannabinoid components delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Administered through a spray pump under the tongue or on the inside of the cheek, it gained its first approval as a prescription medicine in Canada in April 2005.
GW, licensed by the UK Home Office to undertake 'a pharmaceutical r&d programme to develop cannabis-based prescription medicines', will maintain a significant share of long-term product revenues, and could receive milestone payments totalling up to £46m, including a £12m signature fee, based on the successful completion of each of the ongoing Phase III trials, regulatory approvals and achievement of sales targets.
In countries where Almirall has no direct presence at the time of product launch, a distribution partner will either be agreed with GW, or GW may elect to distribute the product itself. Headquartered in Barcelona, Spain, Almirall generated sales of almost Euro 1bn (£675m) in 2005 and is looking to strengthen its direct presence in Europe and Latin America via affiliates and in-licensing opportunities, particularly in the area of Central Nervous System medicines. It will be investigating and contributing to the cost of developing Sativex in other indications along with GW. Marketing authorisation and commercial product supply responsibilities will remain with GW.
Following receipt of the signature fee, GW's cash balances now total £22m.
In other news, Sativex is currently the subject of an inquest at Sheffield Medico Legal Centre in the UK. 70-year-old Rene Anderson, who suffered with type II diabetes, died from a combination of pneumonia and kidney failure in March 2004. She took part in a three-week Sativex trial six months earlier, and was admitted to hospital 23 days after first taking Sativex. GW are unable to comment at the present time for legal reasons, but Mark Rogerson, a PR representative for GW, said that the company is 'surprised and disappointed' with the action being taken, following the drug being 'well tolerated in over 1,000 patient hours of trials'.