GW Pharma (GWPH) Announces Significant Results from Two Epidiolex Phase 3s

December 1, 2016 6:17 AM EST

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GW Pharmaceuticals plc (Nasdaq: GWPH) announces results from two completed Epidiolex (cannabidiol or CBD) Phase 3 trials, one in Lennox-Gastaut syndrome (LGS) and one in Dravet syndrome (DS), will be presented at the American Epilepsy Society (AES) Annual Meeting, December 2-6, 2016, in Houston, Texas.

More than a dozen independent reports from the State-sponsored Epidiolex Expanded Access Program, as well as additional laboratory studies of CBD, scientific updates, and an overview of the legal and regulatory climate for cannabinoids will also be presented during the meeting. For the first time, company-sponsored activities will be conducted under Greenwich Biosciences, Inc., GW’s new name for its operating unit in the United States.

“We are very excited to share these data from our Phase 3 programs with the epilepsy community. These presentations are the culmination of intensive effort by the GW in-house team and more than 50 participating sites over the past two years, and reflect the courage and commitment of patients and their families. We can now focus on the ultimate goal, which is to gain approval for Epidiolex and make this much-needed treatment available,” said Justin Gover, GW’s Chief Executive Officer. “We have also reached an ideal moment to introduce our new U.S. identity, Greenwich Biosciences, which will be the face of our company to patients and their families, clinicians, and the general public in the United States.”

Greenwich Biosciences (pronounced “gren-ich”), headquartered in Carlsbad, California, is incorporated in the United States and 100% owned by UK-based GW Pharmaceuticals plc. As the corporate parent, GW will remain the publicly-traded entity, be responsible for regulatory filings in the United States, and control the ongoing development and intellectual property associated with Epidiolex and the rest of the company’s cannabinoid pipeline.

Results of Phase 3 Studies

Saturday, December 3; 12:00 – 6:00 PM CST/Poster SessionCannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome: results of a multi-center, randomized, double-blind, placebo-controlled trial (GWPCARE4)

Sunday, December 4; 10:00 AM – 4:00 PM CST/Poster SessionA dose ranging safety and pharmacokinetic study of cannabidiol (CBD) in children with Dravet syndrome (GWPCARE1)

Cannabidiol (CBD) reduces convulsive seizure frequency in Dravet syndrome: results of a multi-center, randomized, controlled trial (GWPCARE1)

Additional Laboratory Results

Saturday, December 3; 12:00 – 6:00 PM CST/Poster SessionThe effect of a pharmaceutical formulation of pure cannabidiol on human CNS-expressed voltage-gated sodium channels

Expanded Access Program Presentations

Thirteen independent reports from the State-sponsored Expanded Access Program, including 11 posters from Alabama (two of which will also be given as oral presentations) and one each from Georgia and Idaho, covering varying aspects of the use of Epidiolex in children and adults, will be presented during sessions on Saturday, Sunday and Monday.

Scientific Exhibit Presentations

Monday, December 58:00 AM – 11:00 AM CST, Room 330A, Convention Center Level 3

The company will host a satellite exhibit providing meeting attendees with a comprehensive overview of the Epidiolex development program, including the data presented in the AES poster sessions and the following additional topics (authors will be on hand):

  • Cannabidiol does not convert to Δ9-tetrahydrocannabinol (THC) in an in vivo animal model
  • Epidiolex (cannabidiol) phase III data in treatment resistant epilepsy (encore to poster presentations)
  • Assessment of the anticonvulsant effects and tolerability profile of cannabidiol in GW pharmaceuticals’ preclinical and anticonvulsant screening programs
  • Pipeline update
  • Ongoing Epidiolex trials
  • History of cannabidiol (CBD)

GW Pharmaceuticals Innovation Pavilion

Alice Mead, JD, Vice President, U.S. Professional Relations, will present information on the evolving legal and regulatory climate for cannabinoids:

Monday, December 5Demystifying the Legality of Cannabinoids11:00 AM – 11:20 AM CST/Q&A: 11:20 AM CST12:00 PM – 12:20 PM CST/Q&A: 12:20 PM CST1:00 PM – 1:20 PM CST/ Q&A 1:20 PM CSTGeorge R. Brown Convention Center, Pavilion C

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