GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Epidiolex® (cannabidiol) Data and Educational Programs at the American Epilepsy Society Annual Meeting

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Nov 21, 2017

Over 20 abstracts released online today from Phase 3 programs in Lennox-Gastaut Syndrome and Dravet syndrome and from Expanded Access Program

LONDON, Nov. 21, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its US subsidiary Greenwich Biosciences, announced today that new results from completed Phase 3 trials of Epidiolex® (cannabidiol or CBD) in Lennox-Gastaut syndrome (LGS) and Dravet syndrome, along with other supportive data, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 1-5, 2017, in Washington D.C.

Abstracts released today include the following highlights:

  • Responder analyses from pooled Phase 3 data of LGS patients on/off clobazam
  • Data from two expanded access sites in patients on/off clobazam
  • Long-term maintenance treatment effect and safety in the open label extension study and the expanded access program
  • Exposure-response analysis of CBD in Phase 3 LGS studies

"We continue to see a robust flow of data from the Epidiolex clinical program and look forward to sharing these new data with the epilepsy community at AES. Importantly, data in the abstracts show long-term maintenance of safety and efficacy, as well as that patients on Epidiolex who achieved clinically meaningful responses did so regardless of concomitant clobazam therapy," said Justin Gover, GW's Chief Executive Officer. "Having recently completed our New Drug Application submission to the FDA, we are now focused on the goal of gaining approval for Epidiolex in mid-2018 and making this much-needed, first-in-class medicine available to the patients who need it."

The Epidiolex-related presentations at AES will include more than 20 posters from the Phase 3 pivotal trials, reports from the Expanded Access Program, as well as additional Phase I and pre-clinical studies of CBD. GW/Greenwich will also host a scientific pavilion where additional scientific updates, legal and regulatory perspectives, and other related data will be presented. Company-sponsored activities will be conducted under the Greenwich Biosciences, Inc. name.

Highlights:

Drug-drug interaction data:

Cannabidiol (CBD) Treatment Responders Analysis in Patients with Lennox-Gastaut Syndrome (LGS) On and Off Clobazam (CLB) — Thiele et al (Poster #1.436, Poster Session 1, Saturday, December 2, 2017)

Efficacy of Cannabidiol in Patients with Refractory Epilepsy Relative to Concomitant Use of Clobazam — Bruno et al (Poster #3.181, Poster Session 3, Monday, December 4, 2017)

Presence of Clobazam does not affect Seizure Frequency and Severity in Patients Taking a Pharmaceutical Formulation of Cannabidiol (CBD) — Gaston et al (Poster #2.319, Poster Session 2, Sunday, December 3, 2017)

Bidirectional Drug-drug Interaction with coadministration of Cannabidiol and Clobazam in a Phase 1 Healthy Volunteer Trial — Sommerville et al (Poster #1.433, Poster Session 1, Saturday, December 2, 2017)

CBD Exposure-response

Exposure-Response Analysis of CBD Oral Solution for the Treatment of LGS — Morrison et al  (Poster #2.281, Poster Session 2, Sunday, December 3, 2017)

Long-term Epidiolex data:

Maintenance of Long-Term Safety and Efficacy of Cannabidiol (CBD) Treatment in Dravet Syndrome (DS): Results of the Open-Label Extension (OLE) Trial (GWPCARE 5) — Devinsky et al (Poster #: 1.289, Poster Session 1, Saturday, December 2, 2017)

Maintained Safety and Efficacy of CBD in a Long-Term Open-Label Trial in Patients with LGS (GWPCARE 5) — Marsh et al (Poster #2.271. Poster Session 2, Sunday, December 3, 2017)

Long-Term Effectiveness and Safety of Cannabidiol in Children and Adults with Treatment-resistant Lennox-Gastaut Syndrome or Dravet Syndrome - Laux et al (Poster #1.434 Poster Session 1, Saturday, December 2, 2017)

Long-term Efficacy and Safety of Cannabidiol (CBD) in Children and Adults with TreatmentResistant Epilepsies (TRE) -  Bebin et al (Poster #2.427; Poster Session 2, Sunday, December 3, 2017)

Pooled Phase 3 LGS Data:

CBD Significantly Reduces Drop Seizure Frequency in LGS: Pooled Efficacy and Safety Results from 2 Randomized, Controlled Trials - Patel et al (Poster #1.291, Poster Session 1, Saturday, December 2, 2017)

CBD Treatment Effect and Adverse Events by Time in Patients with LGS: Pooled Results from 2 Trials - Privitera et al (Poster #2.279; Poster Session 2, Sunday, December 3, 2017)

Burden of Illness Data:

Poster Session 1, Saturday, December 2, 2017

  • The Direct Cost Burden of Illness of Dravet Syndrome in the US — Chez et al (Poster #1.314)
     
  • The Direct Cost Burden of Illness of LGS in the US — Montouris et al (Poster #1.315)

Pre-Clinical and Phase I Results:

Poster Session 1, Saturday, December 2, 2017

  • The human metabolite of cannabidiol, 7-hydroxy cannabidiol, but not 7-carboxy cannabidiol, is anticonvulsant in the maximal electroshock seizure threshold test (MEST) in mouse — Whalley et al (Poster #1.435)
     
  • Antiseizure properties of CBD are attenuated in the absence of TRPV1 receptors — Jones et al (Poster #1.022)
     
  • A role of GPR55 in the anti-epileptic properties of CBD — Bazelot et al (Poster #1.029)

Poster Session 2, Sunday, December 3, 2017

  • CBD improves the welfare and survival of Dravet syndrome mice — Petra et al (Poster #2.263)
     
  • Single Therapeutic and Supratherapeutic Doses of CBD Do Not Significantly Impact Heart Rate (HR) Corrected QT Interval (QTc) — VanLandingham et al (Poster #2.280)

Expanded Access Program:

More than a dozen posters from the Expanded Access Program covering varying aspects of the use of Epidiolex in children and adults will be presented during sessions on Saturday, Sunday and Monday. 

Scientific Exhibit:

Advancing Cannabidiol: GWPCARE Phase III Trials and Long-term Results
Monday, December 4
8:00 — 11:00 AM EST
Salon B, Street Level

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):

  • GW Pipeline
  • History of Cannabidiol (CBD) and GW Clinical Trial Program
  • Ongoing GWPCARE Phase III Trials
  • Assessment of the Abuse Potential of Cannabidiol (CBD) in Recreational Polydrug Users: A Randomized, Double-blind, Controlled Trial
  • Pharmacokinetics and Safety Evaluation of Cannabidiol (CBD) in Subjects With Hepatic or Renal Impairment: Results of Two Phase I Trials
  • Cannabidiol improves seizures and epilepsy associated co-morbidities in rats

GW Pharmaceuticals Innovation Pavilion: Presentations on Continuum of Care and Cannabinoid Science
Saturday, December 2
12:00pm — 6:00pm EST
Pavilion D

12:00pm-1:00pm




Nurses Hour w/light lunch

Demystifying the legal landscape of cannabinoids

Cannabinoid Experiences and learnings
Alice Mead, JD

Patricia Bruno, RN, BSN, MGH
2:30pm — 3:30pmSyndrome Identification and Continuum of CareElizabeth Thiele, MD, PhD
Ian Miller, MD
1:15pm-1:45pm
and
4:00pm —
4:30pm
Demystifying the legal landscape of cannabinoids



Alice Mead, JD



1:45pm-2:15pm
and
4:30pm-5:00pm
Cannabinoid Preclinical Science


Ben Whalley, PhD


About Epidiolex® (cannabidiol)

Epidiolex, GW's lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome with an expected approval and launch in 2018. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS and Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms.

About GW Pharmaceuticals plc and Greenwich Biosciences

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioblastoma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Epidiolex® (cannabidiol) and the safety profile and commercial potential of Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Enquiries:

GW Pharmaceuticals plc 
Stephen Schultz, VP Investor Relations (U.S.)917 280 2424 / 401 500 6570
  
U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
 
Christy Curran
Mike Beyer
615 414 8668
312 961 2502

 

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