GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on EPIDIOLEX® (cannabidiol) Oral Solution at the American Epilepsy Society Annual Meeting

Meeting Highlights Include New Phase 3 Data for EPIDIOLEX in Tuberous Sclerosis Complex and Award-Winning Virtual Reality Experience

LONDON and CARLSBAD, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences announced today that a variety of data, including results from completed Phase 3 trials of EPIDIOLEX^® (cannabidiol) oral solution CV, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 6-10, in Baltimore. EPIDIOLEX is approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. It is also approved in Europe, in conjunction with clobazam, for seizures associated with both conditions under the brand name EPIDYOLEX. It is available by prescription for patients two years of age and older.

New data from the Phase 3 study of EPIDIOLEX in patients with tuberous sclerosis complex (TSC) will be presented for the first time at the meeting, along with 3-year safety and efficacy results from an open-label extension study in patients with LGS and Dravet syndrome. GW/Greenwich will host commercial and medical booths as well as a scientific exhibit where AES attendees can learn more about EPIDIOLEX.

The Company will also host an Innovation Pavilion where attendees can discover the stories of those treated with EPIDIOLEX; hear about the journey of the only CBD product approved by the FDA; and attend an interactive expert-panel discussion on managing patients on EPIDIOLEX. Attendees can also immerse themselves in the Company’s CBD growing and manufacturing processes through an award-winning virtual reality experience.

“We are excited to share our latest data for EPIDIOLEX at AES. This is the first time Phase 3 results in TSC will be presented to the epilepsy medical community, along with updated long-term safety and efficacy results in LGS and Dravet syndrome,” said Justin Gover, GW’s Chief Executive Officer. “This has been an exciting first year, with over 15,000 patients treated with EPIDIOLEX, the only FDA-approved cannabidiol (CBD) and the first in a new class of antiepileptic drugs. Our goal is to expand the EPIDIOLEX product label in 2020 to include seizures associated with TSC. Given that the majority of these patients have treatment-resistant epilepsy, we believe there is a need for promising new treatment options.”

Meeting activities include:

EPIDIOLEX (Booth #517)
Saturday, December 7 – Monday, December 9

Innovation Pavilion: Growing Together (Pavilion D)
Saturday, December 7 – Monday, December 9

• See how Greenwich Biosciences is Growing Innovation with an award-winning virtual reality experience
  ° Saturday 12:00PM-6:00PM
  ° Sunday 10:00AM-4:00PM
  ° Monday 10:00AM-2:00PM
• Hear the EPIDIOLEX journey to FDA approval and learn about non-FDA-approved CBD
  Alice Mead, J.D., LLM, & Jennifer Marlo-Triemstra, M.S., Ph.D.
  Saturday & Sunday 1:00PM-2:00PM
• Learn about EPIDIOLEX patient management
  An interactive panel with Ian Miller, M.D.; Barry Gidal, Pharm.D.; & Robert Wechsler, M.D., Ph.D.
  Saturday & Sunday 2:00PM-3:00PM

Scientific Exhibition (Convention Center: Room 324-326, Level 300)
Monday, December 9, 8:00AM-11:00AM

Data Presentations

Phase 3 and Long-term EPIDIOLEX data

• Cannabidiol (CBD) Treatment in Patients with Seizures Associated with Tuberous Sclerosis Complex: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial – Thiele et al. (Saturday, December 7, Poster #1.293)
  
• Long-Term Safety and Efficacy of Add-on Cannabidiol (CBD) Treatment in Patients with Lennox-Gastaut Syndrome (LGS): 3-Year Results of an Open-Label Extension Trial – Patel et al. (Sunday, December 8, Poster #2.436)
  
• Long-Term Safety and Efficacy of Add-on Cannabidiol (CBD) Treatment in Patients with Dravet Syndrome (DS): 3-Year Results of an Open-Label Extension Trial – Scheffer et al. (Sunday, December 8, Poster #2.437)
  
• Time to Onset of Cannabidiol (CBD) Treatment Effect and Resolution of Adverse Events – Madan Cohen et al. (Monday, December 9, Poster #3.317)

Drug-drug interactions

• Cannabidiol Drug-Drug Interaction with Other Commonly Used Antiepileptic Drugs in an Acute Mouse Model of Generalized Seizures – Rana et al. (Monday, December 9, Poster #3.333)

About EPIDIOLEX^® (cannabidiol) oral solution CV

EPIDIOLEX, the first prescription, plant-derived cannabinoid medicine in the United States and the first in a new class of anti-epileptic medications, is a pharmaceutical formulation of highly purified cannabidiol (CBD) now FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. EPIDYOLEX^® (European brand name) is approved in Europe for use as an adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. GW has received Orphan Drug Designation from the FDA, for EPIDIOLEX for the treatment of Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes. GW has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidyolex for the treatment of seizures associated with LGS, Dravet syndrome and TSC.

About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

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’s lead product, EPIDIOLEX (cannabidiol) oral solution CV, is commercialized in the US by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in Europe under the tradename EPIDYOLEX^®. The Company continues to evaluate EPIDIOLEX in additional rare conditions including tuberous sclerosis complex (TSC) and Rett syndrome. 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 and for which the Company is now advancing a late-stage program in order to seek FDA approval. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, autism, glioblastoma, and schizophrenia. For further information, please visit www.gwpharm.com.

Important Safety Information
Important safety information for Epidiolex is available at Epidiolex.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^®/EPIDYOLEX^® (cannabidiol) oral solution CV and Sativex^® (nabiximols), and the safety profile and commercial potential of both medicines. 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 EPIDIOLEX^®/EPIDYOLEX^®, Sativex^® 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. 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.

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