Last 351.25 GBp
Change Today -8.25 / -2.29%
Volume 40.3K
As of 7:35 AM 12/24/14 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, engages in the development of cannabinoid prescription medicines using botanical extracts derived from the Cannabis Sativa plant. The company develops a portfolio of cannabinoid medicines, of which the main product is Sativex, an oromucosal spray for the treatment of multiple sclerosis (MS) symptoms, cancer pain and neuropathic pain. Product and Product Candidates Sativex The company’s most advanced 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 cannabidiol (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. The company’s ongoing Phase 3 program is being conducted under an investigational new drug application (IND) and consists of three clinical trials. Sativex is commercially available for the treatment of MS spasticity in 15 countries outside the United States. The company also has received regulatory approval for Sativex for MS spasticity in 12 additional countries. Epidiolex The company’s most advanced product candidate in the field of epilepsy is Epidiolex, a liquid formulation of a pure plant-derived CBD. The company has commenced a formal clinical trial program with the U.S. Food and Drug Administration (FDA) in Dravet syndrome, for which the company has received Fast Track Designation. GWP42006 In addition to Epidiolex, the company’s epilepsy product candidates also include GWP42006, which features Cannabidivarin (CBDV) as the primary cannabinoid. CBDV is similar in chemical structure to CBD and also has shown anti-epileptic properties across a range of in vitro and in vivo models of epilepsy. GWP42006 has the potential for development in the field of pediatric epilepsy, as well as the broader epilepsy market. Other Orphan Product Candidates Beyond epilepsy-related orphan diseases, in October 2013, the company commenced a Phase 1b study in 20 patients of its combination GWP42002:GWP42003 product, which includes the cannabinoids CBD and THC, in the treatment of recurrent glioblastoma multiforme (GBM), a particularly aggressive brain tumor. Other Pipeline Product Candidates Ulcerative Colitis (UC): UC is a chronic, relapsing inflammatory disease affecting the colon which can cause pain, urgent diarrhea, severe tiredness and loss of weight. GW has completed a 10-week randomized, double-blind, placebo-controlled Phase 2a study of GWP42003 extract, which features CBD as the primary cannabinoid and which also contains other cannabinoid and non-cannabinoid components, in the treatment of ulcerative colitis in patients who had not been able to gain remission from the condition despite first line treatment with salicylates, and in some cases immunosuppressive therapy. Type-2 Diabetes In 2014, the company commenced a 12-week randomized, double-blind, placebo-controlled Phase 2 study of GWP42004 to treat type-2 diabetes. GWP42004 is an orally administered product which features plant-derived tetrahydrocannabivarin (THCV) as its active ingredient. Schizophrenia In 2014, the company commenced a Phase 2a trial using GWP42003 to treat schizophrenia, featuring purified CBD as its active ingredient. The primary objective of this study is to compare the change in symptom severity in patients with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo, added to first-line anti-psychotic therapy over a period of six weeks as change from baseline to the end of treatment using the Positive and Negative Symptom Scale (PANSS) total score. Strategic Partnerships To support the development and commercialization of Sativex, the company has entered into license and development agreements with the following pharmaceutical companies: Otsuka in the United States; Almirall S.A., or Almirall, in Europe (excluding the United Kingdom) and Mexico; Novartis Pharma AG, or Novartis, in Australia and New Zealand, Asia

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