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GW Pharmaceuticals plc announces that it has signed an amendment to its Sativex® licence agreement with Almirall S.A. As part of the revised agreement, Almirall has been granted rights to market Sativex® in Mexico and GW will receive a new near term milestone payment of €12 million (£10 million).

sativex mexico cancer pain Under the terms of the original licence agreement signed in December 2005, Almirall was granted exclusive rights to market Sativex® in Europe (excluding the UK). With Sativex® now approved and launched by Almirall in certain European countries and with further launches planned, GW and Almirall have revisited the financial terms in order to optimise the agreement to best suit the current strategic interests of both companies.

In return for Almirall agreeing to pay to GW a new milestone payment of €12m (£10m) based on a near term cancer pain trial recruitment target, GW has agreed to reduce the Sativex® supply price charged by GW to Almirall over the next few years until the launch of Sativex® in the cancer pain indication in Europe and has agreed to cancel future cancer pain launch milestones of £5.5m. In addition, Almirall has been granted exclusive rights to commercialise Sativex® in Mexico, a country in which Almirall has had an affiliate in place for more than a decade.

Luciano Conde, Chief Operating Officer of Almirall, said “We have been very pleased with our partnership with GW and the initial market response to Sativex®. Sativex® is a new therapeutic option to alleviate suffering from the physical impairment caused by muscle spasticity and Almirall has been committed to ensuring its availability across Europe and now also in Mexico.”

Justin Gover, Managing Director of GW, said “We are delighted to expand our long term relationship with Almirall. We have been impressed with their commitment to the product and pleased with their success to date. 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 United States market and for the future cancer pain indication. 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 30 September 2012.”

Sativex® is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic. In addition, a Mutual Recognition Procedure (MRP) regulatory filing is currently underway to expand Sativex® approvals to ten additional European countries. It is expected that this new MRP process should complete around mid 2012.

Sativex® is approved as a treatment for spasticity in people with Multiple Sclerosis. The product is also in Phase III clinical development as a treatment for cancer pain.

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