Almirall and GKV-SV reach agreement on pricing of Sativex medicine in Germany

Sep 23 2013

GW Pharmaceuticals plc (AIM: GWP, Nasdaq: GWPH, "GW") announced today that agreement for a revised mutually-acceptable reimbursement price for Sativex® has been reached between Almirall S.A., GW's commercial partner in Germany, and the German National Association of Statutory Health Insurance Funds (GKV-SV). This new agreement has resulted in an increase to the previously reduced price imposed by the German authorities in March 2013 which Almirall had considered to be unacceptable.

"We are pleased to have a positive outcome to discussions that result in an acceptable reimbursement price for Sativex® in Germany, Europe's largest potential market for Sativex®. This agreement ensures that people suffering from Multiple Sclerosis spasticity in Germany will have long-term access to this important medicine," stated Justin Gover, GW's Chief Executive Officer.

It is estimated that approximately 4,000 patients are currently being treated with Sativex in Germany.

"Almirall is committed to meeting the needs of MS patients and this is the reason we have been determined over recent months to achieve an appropriate resolution of the reimbursement price in Germany," said Farid Taha, General Manager of Almirall Hermal Company. "Sativex^® represents an important advance in the symptomatic treatment of MS spasticity and this new agreement provides doctors and patients in Germany with the necessary assurance that Sativex® represents not only a recognised therapeutic benefit, but will also be available on prescription for the long-term."

The full text of the joint announcement issued by Almirall and the GKV-SV is below. (NOTE: the following press release is translated into English for the convenience of the reader. Some variation may have occurred in this translation.)

Reimbursement amount for therapeutic agent for MS agreed upon

Berlin, 23 September 2013 – The pharmaceutical company Almirall Hermal GmbH and the National Association of Statutory Health Insurance Funds agreed on 23 September 2013 on a reimbursement amount for the medicine Sativex®.

Sativex® is approved as an add-on therapy for the alleviation of symptoms in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medications. This is the first medication based on two cannabinoids – delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These plant-derived cannabinoids are able to modulate the body's own cannabinoid system, which leads to improved regulation of nerve impulse in responders. This in turn leads to a decrease in spasticity. The basis for the negotiations was the decision on benefit assessment by the Joint Federal Committee dated 21 June 2012, in which the medication was said to show indications of a slight added benefit. This was the second negotiation regarding this medication and the new outcome reflects the impact of changes, in the interim period, to the framework upon which the reimbursement criteria are determined. New negotiations commenced as a result of Almirall issuing an orderly termination of the existing contract as at June 2013.

Farid Taha, managing director of Almirall Hermal GmbH, and Johann-Magnus v. Stackelberg, deputy chairman of the National Association of Statutory Health Insurance Funds, stated that the negotiations were constructive and fair.

"Both parties to the negotiations were interested in a solution that would benefit patients," said Taha and v. Stackelberg. "That was the foundation on which an agreement was finally reached."