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GW Pharmaceuticals Announces Sativex® Commercialization Approval in Italy


5/7/2013 9:32:40 AM

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LONDON, May 7, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW" or the "Company"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces that it has received commercialization approval for its prescription medicine Sativex® in Italy. A full marketing authorization has been granted by the authorities in Italy for the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. This license to market Sativex® in Italy comes by way of the publication of Sativex® in the Italian Official Journal (Gazzetta Ufficiale) and reflects that regulatory, pricing and reimbursement approvals are now in place for an expected commercial launch in September by GW's partner, Almirall S.A. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex® price in Spain.

The publication of Sativex® in the Italian Official Journal triggers a 250,000 milestone payment from Almirall to GW.

"The approval in Italy brings the total to 21 countries that have approved Sativex® for use in the treatment of MS spasticity," stated Justin Gover, Chief Executive Officer of GW. "In granting reimbursement approval for Sativex®, we appreciate the foresight of the Italian authorities in recognizing the value of a medicine that treats a particularly debilitating symptom of MS that is not adequately treated with currently available medications. We now look forward to working with our partners Almirall towards commercial launch in this important market in a few months' time."

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 20 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and at least two additional programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit www.gwpharm.com

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding regulatory clearance of GW's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including its most recent Form F-1. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

SOURCE GW Pharmaceuticals plc



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