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

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."

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GW Pharmaceuticals plc Announces Sativex® Launch in Italy