BioWorld International Correspondent
LONDON - GW Pharmaceuticals plc landed Bayer AG as marketing partner for its cannabis-based drug, Sativex, in a deal with an up-front fee, £25 million in milestones and a significant share of revenues.
The agreement gives Bayer, of Leverkusen, Germany, exclusive rights to market the product in the UK and an option to negotiate marketing rights elsewhere in Europe as well as certain (but unspecified) other countries.
Geoffrey Guy, executive chairman at GW, said, "GW's commercial strategy is to maximize the value of its products by entering into agreements at a late stage of development. The terms of this agreement reflect the merits of this strategy."
Salisbury-based GW needed UK government approval to grow cannabis to extract the two principal components of Sativex, tetranabinex (tetrahydrocannabinol) and nabidiolex (cannabidiol). The company will be responsible for commercial product supply, allowing it to retain a share of revenues from product sales. The drug is administered as a sublingual spray and contract manufacturing is in place, it said.
GW submitted a UK license application for Sativex in March. Of the £25 million (US$15.6 million) in milestones, £10 million is immediately available as an interest-free working capital facility to pay for market-launch preparations. The facility can be drawn down at GW's discretion until Sativex is approved, at which point Bayer has the option to convert the remainder into a milestone payment or into GW shares. If Bayer exercises its option for countries outside the UK, additional milestones would be payable on a country-by-country basis.
GW reported data from four Phase III trials of Sativex in November. The studies showed statistically significant reductions in pain, spasticity and sleep disturbance in multiple sclerosis patients, and a significant reduction in pain levels in sufferers of neuropathic pain.
The UK government has said that if UK regulators approve a cannabis-based medicine it would amend legislation to allow it to be available by prescription.