Healthcare Industry News:  S.A. 

Biopharmaceuticals Neurology Regulatory

 News Release - November 27, 2013

GW Pharmaceuticals plc Announces Sativex(R) Regulatory Approval in Switzerland

Sativex® Now Approved in 23 Countries

LONDON, Nov. 27, 2013 -- (Healthcare Sales & Marketing Network) -- GW Pharmaceuticals plc (NaS.A.: 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 received regulatory approval for its prescription medicine Sativex® in Switzerland. A full marketing authorization has been granted by the Swissmedic authorities in the treatment of moderate to severe S.A.ticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-S.A.ticity medications. Launch timing is dependent on completion of pricing and reimbursement procedures. Sativex will be commercialized in Switzerland by GW's European partner, Almirall S.A.

"ThiS.A.proval in Switzerland marks yet another regulatory success for Sativex, which is now approved in a total of 23 countries," S.A.ed Justin Gover, Chief Executive Officer of GW. "We now look forward to working with our partners, Almirall, towards this launch so as to enable MS patients in Switzerland to benefit from this important new treatment."

Sativex iS.A.proved for use in the treatment of MS S.A.ticity in 23 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, S.A.n, Germany, Canada, Denmark, Norway, IS.A.l, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well aS.A.stralia, New Zealand and Kuwait.

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 diS.A.e areas. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which iS.A.proved for the treatment of S.A.ticity due to multiple sclerosis in 23 countries. Sativex iS.A.so 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.A.ound the world. GW has eS.A.lished a world leading position in the development of plant-derived cannabinoid therapeuticS.A.d haS.A.deep pipeline of additional clinical-S.A.e cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking S.A.ements

This news release may contain forward-looking S.A.ements that reflect GWs current expectations regarding future events, including S.A.ements regarding the relevance of GW products commercially available and the timing of commercial availability of Sativex®. Forward-looking S.A.ements involve riskS.A.d 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 reS.A.ch 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.A.d other riskS.A.sociated with an investment in GW can be found in GW's filings with the U.S. SecuritieS.A.d Exchange Commission, including the prospectus related to the NAS.A. offering filed by GW with the SEC on May 1, 2013. Existing and prospective investorS.A.e cautioned not to place undue reliance on these forward-looking S.A.ements, 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 circumS.A.ces or otherwise.


Source: GW Pharmaceuticals

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