Bayer announces marketing agreement on cannabis-based treatment
Bayer has entered into an exclusive marketing agreement with UK company GW Pharmaceuticals for the latter's cannabis-based medicinal extract product, to be marketed under the Sativex brandname.
Bayer has entered into an exclusive marketing agreement with UK company GW Pharmaceuticals for the latter's cannabis-based medicinal extract product, to be marketed under the Sativex brandname.
Bayer has obtained exclusive rights to market Sativex in the UK, as well as the option for a limited period to negotiate the marketing rights in other countries in the EU and selected other countries around the world. GW submitted a product licence application for Sativex to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2003.
The product is a whole plant medicinal cannabis extract containing tetranabinex (tetrahydrocannabinol - THC) and nabidiolex (cannabidiol - CBD) as its principal components. The medicine is administered by means of a spray into the mouth and has been developed by GW for the treatment of Multiple Sclerosis and severe neuropathic pain. Sativex and a THC medicine are also undergoing Phase III trials for the treatment of cancer pain. If approved, Bayer will also market these medicines for cancer pain.
GW is to be responsible for commercial product supply and has entered into a supply agreement with Bayer. GW will manage the supply of product through a range of contract manufacturing partners, arrangements for which are all in place.
In addition to a share of product revenues, GW has received a signature fee and will receive additional fees on regulatory approval in the UK of the initial indications of MS, neuropathic pain and cancer pain, totalling £25m (€34.9m). If Bayer exercises the option for countries outside the UK, additional milestones shall be payable on a country by country basis.