GW Pharmaceuticals and Almirall have amended their licensing agreement for GW’s cannabinoid-based multiple sclerosis spasticity drug Sativex®. Almirall now has new exclusive marketing rights in Mexico. Additionally, GW Pharm will receive a new near-term milestone payment of £10 million (about $15.7 million) from Almirall and in return will reduce the supply price of Sativex charged to Almirall over the next few years until the drug is launched in Europe for the cancer pain indication.
GW will also cancel future cancer pain launch milestones, which would have amounted to £5.5 million. Sativex is currently undergoing Phase III development for the cancer pain indication.
“The new near-term milestone payment will further strengthen our balance sheet at a time when we are supporting multiple European Sativex launches as well as planning to expand manufacturing for the U.S. market and for the future cancer pain indication,” comments Justin Gover, GW’s managing director. “A further consequence of this new near-term milestone payment is that GW now expects to report a small profit in the current financial year ending September 30, 2012.”
Spain’s Almirall already holds exclusive marketing rights to Sativex in Europe, under its original license agreement with GW, signed at the end of 2005. The drug has been approved and launched by Almirall in a number of European countries, and further European launches are planned. A regulatory filing under the European Mutual Recognition Procedure is also under way to expand Sativex approvals to additional EC countries.