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GW Pharmaceuticals Files New Regulatory Application to Expand Sativex® Approval to France


7/22/2013 8:29:07 AM

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LONDON, July 22, 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, announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorization for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).

This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.

Sativex is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with launches currently in preparation for a further 8 European countries, as well as Australia and New Zealand.

"Sativex meets a significant unmet medical need for patients with Multiple Sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "The submission of this MRP for Sativexin France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe. We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with Multiple Sclerosis."

Almirall, an international pharmaceutical company with headquarters in Spain, is the exclusive distribution partner for Sativex in the European Union (excluding the United Kingdom) and E.U. accession countries, as well as Switzerland, Norway, Turkey and Mexico.

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 21 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 the timing of clinical trials, the relevance of GW products commercially available and in development, the size of Sativex market opportunities, and the development and regulatory clearance of the 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 the prospectus related to the Nasdaq offering filed by GW with the SEC on May 1, 2013. 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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