- Epidiolex^® NDA submission process underway - 
- Conference call today at 4:30 p.m. EDT -

LONDON and CARLSBAD, Calif., Aug. 07, 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, announces financial results for the third quarter ended 30 June 2017.
                                      
“I am pleased to report the NDA submission process for Epidiolex is now underway with the final sections of the submission expected to be completed in October. With a clear view now towards our anticipated approval, we are making excellent progress with preparations to ensure a highly successful launch in 2018,” stated Justin Gover, GW’s Chief Executive Officer. “Following the recent publication of our first Phase 3 trial in The New England Journal of Medicine, we look forward to additional Epidiolex data publications and presentations in the second half of the year. In addition to Epidiolex, we continue to keep focus on our growing and innovative cannabinoid pipeline where we have advanced a number of additional exciting clinical programs.”

OPERATIONAL HIGHLIGHTS

• Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)

• Regulatory progress: 
  - NDA rolling submission for both Dravet and LGS indications underway. Pre-clinical module submitted;  Clinical module submission in progress; CMC module submission expected in October
  - EMA pre-submission meetings held. Expected EU regulatory submission in Q4 2017
  
  
• Further clinical progress:
  - Phase 3 Dravet syndrome trial published in The New England Journal of Medicine 
  - Quality of Life in Childhood Epilepsy published in Epilepsia 
  - Phase 3 trial in Tuberous Sclerosis Complex ongoing
  - Part A of two-part Phase 3 trial in Infantile Spasms ongoing
  - Numerous abstracts submitted to American Epilepsy Society annual meeting
  
  
• Manufacturing scale-up on track to deliver significant projected commercial launch inventory:
  - Preparations on track for FDA GMP inspection anticipated in early 2018
  
  
• Expanded access program and open label extension:
  - Over 1,500 patients now exposed to Epidiolex treatment 
  - 97 percent of patients who complete Phase 3 trials have entered long term extension
  
  
• Commercial progress:
  - U.S. pre-launch commercial leadership team in place
  - Full team of epilepsy specialist Medical and Scientific Liaisons (MSLs) in place with significant medical education initiatives underway and major presence at key target congresses 
  - EU commercial team build-out underway and increasing presence at European congresses
  
  
• Strengthened Epidiolex exclusivity:
  - 14 distinct patent families in prosecution relating to the use of CBD in the treatment of epilepsy; decisions expected for several patents towards end 2017 and H1 2018
  - 6 patents published in the last quarter claiming various methods of treatment using CBD 
  
  
• Life-cycle management:
  - Several new formulations of CBD in Phase 1 trials

• Progressed cannabinoid pipeline product candidates

• CBDV Phase 2 partial-onset epilepsy study in adults fully enrolled. Data expected end 2017/early 2018
  
  
• CBDV in field of autism spectrum disorders:
  - Expanded access IND granted by FDA for 10 patients with autism
  - Open label study in Rett syndrome and Phase 2 placebo-controlled trial in planning for H1 2018
  - Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
  
  
• CBD:THC in Glioblastoma:
  - Positive survival data from Phase 2 study presented recently at ASCO; further follow-up demonstrates continued increased survival in the CBD:THC arm
  
  
• Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program:
  - Phase 1 trial complete
  - Orphan Drug and Fast Track Designations granted from FDA and EMA

• Management appointments

• Dr. Volker Knappertz appointed Chief Medical Officer
  
  
• Douglas Snyder appointed Chief Legal Officer
  
  
• Prof. Ben Whalley appointed as Director of Research

FINANCIAL HIGHLIGHTS

• Cash and cash equivalents at 30 June 2017 of £284.1 million ($369.5 million) compared to £374.4 million as at 30 September 2016

• Revenue for the nine months ended 30 June 2017 of £6.1 million ($7.9 million) compared to £8.6 million for the nine months ended 30 June 2016

• Loss for the nine months ended 30 June 2017 of £90.3 million ($117.5 million) compared to £46.7 million for the nine months ended 30 June 2016

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 30 June 2017 of $1.30081 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the third quarter 2017 financial results today at 4:30 pm EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010. For both dial-in numbers please use conference ID # 13667808 and PIN: 19259.

About GW Pharmaceuticals plc

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has commenced a rolling NDA submission with the FDA for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing Phase 3 clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex^®, which is approved for the treatment of spasticity due to multiple sclerosis in 30 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 glioma, 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 Sativex and Epidiolex and the safety profile and commercial potential of Sativex and 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 of 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	
401 500 6570

Sam Brown (U.S. Media Enquiries)
Christy Curran
615 414 8668