GW Pharmaceuticals plc, a biopharmaceutical company, focuses on discovering, developing and commercializing therapeutics from proprietary cannabinoid product platform in a range of disease areas. The company’s primary cannabinoid product candidate is Epidiolex, a liquid formulation of pure plant-derived cannabidiol (CBD), which is in development for the treatment of various rare pediatric epilepsy disorders. The company is planning to commercialize Epidiolex in the United States and elsewhere using its own sales and marketing organization. The company received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), for Epidiolex for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome (LGS), each of which are severe infantile-onset, genetic, drug-resistant epilepsy syndromes. The company has commenced four pivotal Phase 3 trials of Epidiolex, two in Dravet syndrome and two in LGS, each of which is due to report top-line results in 2016. The company’s strategy for the development of Epidiolex within the field of pediatric epilepsy is to initially concentrate formal development efforts on three orphan indications: Dravet Syndrome, LGS and Tuberous Sclerosis Complex. The company received Orphan Drug Designation from the U.S. FDA for Epidiolex for the treatment of both Dravet syndrome and LGS. Additionally, the company has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency (EMA) for Epidiolex for the treatment of Dravet syndrome. Dravet syndrome is a severe infantile-onset, genetic, drug-resistant epilepsy syndrome with a distinctive but complex electroclinical presentation. In April 2015, the company commenced an additional Phase 3 trial in Dravet syndrome. LGS is a type of epilepsy with multiple types of seizures, particularly tonic (stiffening) and atonic (drop) seizures. In May 2015, the company commenced the Phase 3 pivotal trials program for Epidiolex in LGS. Tuberous Sclerosis Complex is a genetic disorder that causes non-malignant tumors to form in many different organs, primarily in the brain, eyes, heart, kidney, skin and lungs. In addition to Epidiolex, the company’s epilepsy product candidates also include GWP42006, which features CBDV as the primary cannabinoid. The company completed a Phase 1 trial of GWP42006. The company is evaluating a combination product containing GWP42002:GWP42003 in the treatment of recurrent glioblastoma multiforme (GBM), a particularly aggressive brain tumor, which is considered a rare disease by the FDA and the EMA. The company received Orphan Drug Designation from the FDA for GWP 42002:GWP42003 combination for the treatment of GBM. The company completed recruitment of the 20 patient placebo-controlled 2a phase of the trial, and top-line data is expected around mid-2016. In April 2015, the company received Orphan Drug Designation from the FDA for CBD for the treatment of NHIE. In July 2015, the company received Orphan Drug Designation from the EMA for CBD for the treatment of perinatal asphyxia. In addition, in July 2015, the company received Fast Track Designation from the FDA. Trademarks Sativex and Epidiolex are registered trademarks of the company. Intellectual Property The company’s patent portfolio related to the use of CBD and/or Cannabidivarin (CBDV) includes 14 patent families containing 1 or more pending and/or issued patents with claims in the treatment of epilepsy, compositions, extraction techniques, CBD and CBDV extracts and highly purified plant-derived CBD. The company has a patent granted in the U.K., which claims the use of CBD in combination with certain standard anti-epileptic drugs in the treatment of epilepsy. It also had a patent granted in the U.K. in October 2015, which claims the use of CBD in combination with certain standard anti-epileptic drugs in the treatment of epilepsy. The company’s intellectual property portfolio, as of September 30, 2015, included 60 patent families with issued and/or pending claims directed to plants, plant extracts, extraction technology, pharmaceutical formulations, drug delivery and the therapeutic uses of
gw pharmaceuticals plc (GWP:London)
Cambridge, CB24 9BZ
Phone: 44 1223 266 800
Fax: 44 1223 235 667www.gwpharm.com
The information and data displayed in this profile are created and managed by S&P Global Market Intelligence, a division of S&P Global. Bloomberg.com does not create or control the content.
|No competitor information is available for GWP.|
|View Industry Companies|
|Price/Cash Flow||NM||Not Meaningful|
Sponsored Financial Commentaries
To contact GW PHARMACEUTICALS PLC, please visit www.gwpharm.com. Company data is provided by S&P Global Market Intelligence. Please use this form to report any data issues.