GW Pharmaceuticals plc Announces Sativex® Launch in Italy

LONDON, July 8, 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, is pleased to note the announcement from its partner Almirall S.A. that Sativex® is now available in Italy as a prescription medicine for use in the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. The launch follows receipt of full marketing authorization for Sativex® by the Italian health authorities in May. The medicine is reimbursed by the Italian authorities as a Class H (hospital dispensed) medicine. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex® price in Spain.

"As one of the largest markets in Europe, the launch of Sativex® in Italy is a key milestone in the commercialization of this important new medicine. Italy represents yet another addition to the growing number of countries in Europe in which Sativex® is now available to treat MS spasticity, a particularly debilitating symptom of MS that is not adequately treated with currently available medications," stated Justin Gover, Chief Executive Officer of GW. "With a total of 21 countries that have now approved Sativex^® for use in the treatment of MS spasticity, and a further 9 countries in which regulatory submissions are ongoing, we look forward to a series of further commercial launches over the coming twelve months."

The full text of Almirall's announcement is below. (NOTE: the following press release issued by Almirall S.A. is translated into English for the convenience of the reader. Some variation may have occurred in this translation.)

 Almirall Announces the Commercial Launch of Sativex® in Italy

• The first medicine containing cannabinoids for the treatment of spasticity in multiple sclerosis (MS) is available in Italy.
• The new medicine, comprised of two primary active components, THC (delta-9-tetrahidrocannabinol) and CBD (cannabidiol), is administered as an oromucosal spray and contains cannabinoids which are extracted from the cannabis sativa plant (C. sativa) grown and processed under strictly controlled conditions.
• Sativex has demonstrated its efficacy in MS patients suffering from spasticity not adequately controlled by traditional anti-spasticity medications by mitigating symptoms which include muscle stiffness, painful spasms and cramps, bladder problems and sleep disturbance¹.

Milan, 8 July 2013 - HCPs and patients now have an extra weapon to fight against spasticity, one of the most common symptoms associated with MS and one of the main causes of disability linked to this disease. Beginning in July, Sativex® will be available on prescription as the first specific treatment for moderate to severe spasticity in MS patients who have not adequately responded to other anti-spasticity medications. Sativex®, which is reimbursed in H Class (Hospital), is available in hospital pharmacies within MS Centers. In order to monitor therapeutic accuracy and appropriateness, a National Register has been established in which patients treated with Sativex will be enrolled.

"In our country" - declares Giancarlo Comi, Professor of Neurology Universita Vita-Salute San Raffaele - "the majority of patients suffering from MS must cope with the problem of spasticity which not only limits their capacity to walk but often causes sleep disturbance, muscle stiffness, painful spasms and cramps thus making it difficult to complete simple tasks of daily activities. The availability of Sativex^®, which can reduce these troublesome symptoms, offers a brighter perspective to these patients," concludes Comi.

Sativex® is an endocannabinoid modulator comprised of two primary active components, THC (delta-9-tetrahidrocannabinol) and CBD (cannabidiol) which are extracted from the plant C. sativa, grown and cultivated in glasshouses at a secure location under closely controlled growing conditions. Sativex® is administered as an oromucosal spray enabling flexible dosage, according both to individual response and the specific symptoms of each patient, and can be easily taken by patients who have difficulties swallowing.

"Sativex®"- declares Carlo Pozzilli, Professor of Neurology, Universita di Roma "La Sapienza" -"is the first medicine containing cannabinoids extracted from the plant C. sativa to undergo clinical trials in accordance with European legislation and to demonstrate efficacy and safety for the treatment of spasticity in MS. Its primary components, THC and CBD" - continues Pozzilli - "interact with human endocannabinoid receptors CB1 and CB2 by modulating the motor and pain pathways, improving spasticity without causing muscle weakness. The medicine," - concludes Pozzilli - "is generally well tolerated, does not cause  the side effects associated with the use of crude, herbal cannabis, and does not create dependence."

In Italy, it is estimated that 75% of MS patients suffer from spasticity, a symptom which impacts their quality of life and the quality of life of their family and caregivers.  Clinical evidence has demonstrated that Sativex^®, due to its efficacy on spasticity, leads to improved quality of life and to greater patient independence from the help of their relatives and care-givers².

"Consistent with Almirall's objective to provide innovative therapeutic solutions,"- declares Javier Garcia, Chief Executive Officer of Almirall ltalia - "we are pleased to make Sativex® available in Italy. As the first new medicine approved for the treatment of spasticity in MS patients, Sativex addresses the unmet needs of patients and the requirements of HCPs."

Sativex has been approved in 21 Countries in the world and it is already commercialized in 6 other European countries including Germany, Spain, and the United Kingdom. Sativex has been developed by GW Pharmaceuticals plc.  Almirall holds the marketing rights to this medicine in Europe (except for the United Kingdom).

References:

1 Patient leaflet.

2 GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available at: http://www.gwpharm.com/types-compounds.aspx (Last accessed: 03/06/13).

About Almirall

Almirall is a pharmaceutical company engaged in producing valuable drugs from its R&D, external partnerships, licences and cooperations. In 2012 Almirall invested more than 23% of its turnover in R&D. Through the research on innovative drugs we aim at becoming a relevant player in respiratory diseases, dermatology with a strong interest in gastroenterology and in pain. With about 3,000 employees in 22 countries, Almirall had a total turnover of 900 million Euros in 2012. The Company was founded in 1943 and it is based in Barcelona, Spain. It is listed at Spanish exchange (ticker ALM). For further information please visit the website www.almirall.com.

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