Last 428.00 GBp
Change Today -2.00 / -0.47%
Volume 3.4M
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As of 11:35 AM 11/25/14 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

Porton Down Science Park

Salisbury, SP4 0JQ

United Kingdom

Phone: 44 19 8055 7000

Fax: 44 19 8055 7111

GW Pharmaceuticals plc, together with its subsidiaries, is engaged in the research, development, and commercialization of a range of cannabinoid prescription medicines. The company’s plant-derived cannabinoid prescription drug, Sativex is approved for the treatment of spasticity due to multiple sclerosis (MS) in 22 countries outside the United States. The company is also evaluating Sativex in a Phase 3 program for the treatment of cancer pain. The company has a deep pipeline of additional cannabinoid product candidates, including orphan drug opportunities with a particular focus on pediatric epilepsy. In November 2013, the company received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Epidiolex, its proprietary product candidate that contains plant-derived cannabidiol (CBD) as its active ingredient, for the treatment of Dravet syndrome, a severe infantile-onset, genetic, drug-resistant epilepsy syndrome. The company’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis type-2 diabetes, and schizophrenia. The company’s product, Sativex, is an oromucosal spray consisting of a formulated extract of the cannabis sativa plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC), and CBD. The company is evaluating Sativex in a Phase 3 program to treat persistent pain in people with advanced cancer who experience inadequate pain relief from optimized chronic opioid therapy, the standard of care. This program represents the target indication for Sativex in the United States and is based on positive data from two Phase 2 trials of Sativex. The company’s ongoing Phase 3 program is being conducted under an Investigational New Drug Application, and consists of three clinical trials. Sativex is commercially available for the treatment of MS spasticity in 11 countries outside the United States. The company’s proprietary cannabinoid product platform consists of a continually evolving library of internally generated novel cannabis plant types that produce selected cannabinoids, discovery of novel cannabinoid pharmacology through its worldwide network of scientists, its intellectual property portfolio, in-house formulation, processing and manufacturing capabilities, and development and regulatory expertise. The company’s epilepsy product candidates include GWP42006, which features cannabidivarin as the primary cannabinoid and which has shown anti-epileptic properties in pre-clinical studies. For the fiscal year ended September 30, 2013, the company advanced GWP42006 into a Phase 1 trial. Beyond epilepsy-related orphan diseases, in October 2013, the company commenced a Phase 1b trial of its GWP42002:GWP42003 product in the treatment of recurrent glioblastoma, a particularly aggressive brain tumor, which is considered an orphan disease by the FDA and the European Medicines Agency. The company’s cannabinoid product pipeline includes GWP42004, which has completed a Phase 2a trial in the treatment of dyslipidemia in subjects with type-2 diabetes. The company is developing GWP42003, a cannabinoid which has shown anti-inflammatory properties in pre-clinical studies. GWP42003 is in a Phase 2 trial for ulcerative colitis. GWP42003 is also used for the treatment of schizophrenia. To support the development and commercialization of Sativex, the company has license and development agreements with the following major pharmaceutical companies in selected territories: Otsuka Pharmaceutical Co. Ltd. in the United States; Almirall S.A. in Europe (excluding the United Kingdom) and Mexico; Novartis Pharma AG in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel) and Africa; Bayer HealthCare AG in the United Kingdom and Canada; and Neopharm Group in Israel. These agreements provide the company’s collaborators with the sole right to commercialize Sativex in exclusive territories for all indications. Business Strategy The company’s strategies are to secure regulatory approval of Sativex for advanced cancer pain in the United States and around the world; advance its p

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