GW Pharmaceuticals plc

VIENNA, Austria, Aug. 28, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the development and commercialization of cannabinoid prescription medicines, presents a variety of data on cannabidiol oral solution (CBD) at the 13^th Annual European Congress of Epileptology (ECE), taking place in Vienna, Austria from 26-30 August 2018.

The studies provide additional insight into the safety and efficacy of GW’s CBD oral solution in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and severe forms of childhood-onset epilepsy that are highly treatment-resistant^{1 ,2} . In addition, data related to the pharmacology of CBD, and its antiseizure properties, will provide additional understanding of CBD’s role in the management of such diseases. A marketing authorization application for GW’s CBD oral solution is currently under review by the European Medicines Agency (EMA).

“GW is proud to be presenting a wealth of data on its CBD oral solution to the epilepsy community. Our comprehensive pre-clinical and clinical programs provide an understanding of the way in which CBD exhibits anti-seizure effects and further supports its efficacy and tolerability profile in patients living with two of the most difficult-to-treat forms of epilepsy,” stated Justin Gover, GW’s Chief Executive Officer. “There is still a huge unmet medical need for effective medicines that help people suffering from severe forms of treatment resistant epilepsy, and we believe that our CBD oral solution may present an important new therapeutic option in the future.”

CBD data highlights:
Highlights include the presentation of pooled efficacy and safety data from two phase III randomized placebo-controlled trials of CBD in LGS, Phase 1 drug-drug interaction data on the co-administration of CBD and clobazam, and the potential role of GPR55 and the TRPV1 receptor-dependent interaction in the anti-epileptic properties of CBD.

The full list of GW titles presented are as follows:

• Cannabidiol (CBD) Significantly Reduces Drop Seizure Frequency in Lennox-Gastaut Syndrome (LGS): Pooled Efficacy and Safety Results from 2 Randomized, Controlled Trials
• Bidirectional Drug-drug Interaction with coadministration of Cannabidiol and Clobazam in a Phase 1 Healthy Volunteer Trial
• Maintained Safety and Efficacy of Cannabidiol (CBD) in a Long-Term Open-Label Trial in Patients with Lennox-Gastaut Syndrome (LGS) (GWPCARE 5)
• Exposure-Response Analysis of Cannabidiol Oral Solution for the Treatment of Lennox–Gastaut Syndrome
• A Phase 2 Trial to Explore the Potential for a Pharmacokinetic Drug-drug Interaction with Valproate when in Combination with Cannabidiol in Adult Epilepsy Patients (late breaking abstract)
• Antiseizure properties of CBD are attenuated in the absence of TRPV1 receptors
• A role of GPR55 in the anti-epileptic properties of cannabidiol
• 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)
• Bidirectional Drug-drug Interactions with Co-administration of Cannabidiol and Stiripentol or Valproate in a Phase 1 Healthy Volunteer Trial

About GW Pharmaceuticals plc (NASDAQ: GWPH)

Founded in 1998, GW is a world leader in the development and commercialization of cannabinoid prescription medicines. The Company’s lead investigational medicine, cannabidiol oral solution (Epidiolex® in the US), received U.S. FDA approval in June 2018 and is under review by European regulators. Previously, GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (delta-9-tetrahydrocannibinol and cannabidiol) in Europe and is now advancing plans to develop this medicine in the US. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in development for epilepsy, autism, glioblastoma, and schizophrenia. For further information, please visit our global corporate website at 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) oral solution 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 4 December 2017. 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
EU Media Enquiries:
FTI Consulting	+44 (0)20 3727 1000

¹ LGS Foundation. About Lennox-Gastaut Syndrome. Available at http://www.lgsfoundation.org/aboutlgs . Accessed May 7, 2018.

² Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(Suppl. 2):3–9.

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