GW Pharmaceuticals Plc
GW PHARMACEUTICALS PLC (Form: 6-K, Received: 12/05/2016 12:11:13)

 

United States

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of December, 2016

 

Commission File Number: 001-35892

 

GW PHARMACEUTICALS PLC

(Translation of registrant’s name into English)

 

Sovereign House

Vision Park

Histon

Cambridge CB24 9BZ

United Kingdom

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F   x   Form 40-F   ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes   ¨   No   ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes   ¨   No   ¨

 

 

 

 

Other Events

 

On December 5, 2016, GW Pharmaceuticals plc (the “Company”) issued a press release announcing its fourth quarter and year-end 2016 financial results and operational progress and details of a conference call to be held at 8:00 a.m. EST on December 5, 2016 to discuss the results. The press release is attached as Exhibit 99.1 and is incorporated by reference herein.

 

On December 5, 2016, the Company issued a press release announcing additional positive Epidiolex® (cannabidiol or CBD) Phase 3 data in poster presentations at the 70th Annual Meeting of the American Epilepsy Society. The press release is attached as Exhibit 99.2 and is incorporated by reference herein. The posters are also available from the Investors section of the Company’s website.

 

The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.

 

Exhibits    
99.1   Press release dated December 5, 2016
99.2   Press release dated December 5, 2016

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  GW Pharmaceuticals plc
     
  By: /s/ Adam George
  Name:   Adam George
  Title:   Chief Financial Officer
     
Date: December 5, 2016    

 

 

 

 

Exhibit 99.1

 

 

GW Pharmaceuticals plc Reports Fourth Quarter and Year-End 2016 Financial Results and Operational Progress

 

- Three Positive Phase 3 Epidiolex clinical trials reported in 2016 –

- NDA submission and launch preparation on track –

-Conference call today at 8:00 a.m. EST-

 

London, UK, 5 December 2016 : 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, announced financial results for the fourth quarter and year-ended 30 September 2016.

 

“In 2016 GW has completed three positive Phase 3 trials for Epidiolex in patients with two different rare treatment resistant forms of childhood-onset epilepsy and we are making good progress towards an NDA submission. Our sights are now focused on Epidiolex approval and accelerating our preparations for a highly successful launch,” stated Justin Gover, GW’s Chief Executive Officer. “Our goal is to provide the children and their families suffering from these highly treatment-resistant forms of childhood-onset epilepsy with a much needed new prescription option as quickly as possible.”

 

2016 OPERATIONAL HIGHLIGHTS

· Epidiolex ® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
o Phase 3 trials:
§ Positive results in a pivotal Phase 3 Dravet syndrome trial
§ Positive results in two pivotal Phase 3 LGS trials
§ Positive data presented at the American Epilepsy Society Annual Meeting
o Regulatory:
§ Positive Dravet syndrome pre-NDA meeting held with FDA in July 2016
§ Positive CMC pre-NDA meeting held with FDA in November 2016
§ NDA submission for both Dravet and LGS indications expected at end of H1 2017, just 3 years since opening of IND
§ Preparations advancing for EU regulatory submission in H2 2017
o Manufacturing scale-up:
§ Manufacturing scale-up on track to deliver significant commercial launch inventory
o Expanded access program and open label extension:
§ 98% of patients who complete Phase 3 trials have entered long term extension
§ Over 1,000 patients now on Epidiolex treatment
§ NDA submission to include safey data from over 1,500 patients and over 400 patients with 1 year or more continuous exposure
§ Withdrawal rate in long term studies approx 20%
o Commercial:
§ US commercial team build underway and pre-launch preparations advancing well
§ EU commercial team now being established

 

 

 

 

o Additional indications:
§ Phase 3 trial in TSC ongoing
§ Two part Phase 3 trial in IS commenced in December 2016
o Intellectual Property:
§ Patent portfolio being prosecuted with claims directed to the use of CBD in the treatment of epilepsy seizure subtypes and epilepsy syndromes

 

· Advanced clinical programs in multiple cannabinoid pipeline product candidates:
o CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected mid-2017
o CBDV pre-clinical research ongoing within field of autism spectrum disorders. Phase 2 trials expected to commence in Q3 2017
§ Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
o Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
§ Phase 1 trial commenced in December 2016
§ Orphan Drug and Fast Track Designations granted from FDA and EMA
o THC:CBD for the treatment of Recurrent Glioblastoma Multiforme (GBM)
§ Phase 1b/2a study completed – data expected Q1 2017
§ Orphan Drug Designation from FDA
o Sativex ® Phase 2 study in children with spasticity due to cerebral palsy completed – data expected Q1 2017

 

FINANCIAL HIGHLIGHTS

 

· Revenue for the twelve months ended 30 September 2016 of £10.3 million ($13.3 million) compared to £28.5 million for the twelve months ended 30 September 2015.

 

· Loss for the twelve months ended 30 September 2016 of £63.7 million ($82.2 million) compared to £44.6 million for the twelve months ended 30 September 2015.

 

· Cash and cash equivalents at 30 September 2016 of £374.4 million ($483.4 million) compared to £234.9 million as at 30 September 2015.

 

Conference Call and Webcast Information

 

GW Pharmaceuticals will host a conference call and webcast to discuss the fourth quarter and year-end 2016 financial results today at 8:00 a.m.. 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, (international):1-919-882-2331. For both dial-in numbers please use conference ID # 13650870.

 

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), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, 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 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. 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)  
Amanda Foley +44 20 7418 8900

 

Solely for the convenience of the reader, unless otherwise indicated, all pound sterling amounts stated in the Condensed Consolidated Balance Sheet as at 30 September 2016, the Condensed Consolidated Income Statement, Condensed Consolidated Statement of Comprehensive Income, Condensed Consolidated Statement of Changes in Equity and the Condensed Consolidated Cash Flow Statement for the three months and for the year ended 30 September 2016 have been translated into U.S. dollars at the rate on 30 September 2016 of $1.29128 to £1.00. 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.

 

 

 

 

GW Pharmaceuticals plc

Condensed consolidated income statement

Three months ended 30 September 2016

 

    Three months
ended
   

Three months

ended

    Three months
ended
 
    30 September     30 September     30 September  
    2016     2016     2015  
    $000’s     £000’s     £000’s  
Revenue     2,156       1,670       5,595  
Cost of sales     (1,006 )     (779 )     (683 )
Research and development expenditure     (31,401 )     (24,318 )     (25,457 )
Sales, general and administrative expenses     (9,645 )     (7,469 )     (4,988 )
Net foreign exchange gain     8,099       6,272       6,874  
Operating loss     (31,797 )     (24,624 )     (18,659 )
Interest and other income     408       316       83  
Interest expense     (155 )     (120 )     (15 )
Loss before tax     (31,544 )     (24,428 )     (18,591 )
Tax benefit     9,710       7,520       6,358  
Loss for the period     (21,834 )     (16,908 )     (12,233 )
                         
Loss per share – basic and diluted     (7.4c )     (5.7p )     (4.7p )

 

All activities relate to continuing operations.

 

Condensed consolidated statement of comprehensive loss

For the three months ended 30 September 2016

 

   

Three months
ended

30 September

2016

£000’s

   

Three months
ended

30 September

2015

£000’s

 
Loss for the period     (16,908 )     (12,233 )
Items that may be reclassified subsequently to profit or loss                
Exchange differences on translation of foreign operations     183       (51 )
Other comprehensive gain/(loss) for the period     183       (51 )
Total comprehensive loss for the period     (16,725 )     (12,284 )

 

 

 

 

GW Pharmaceuticals plc

Condensed consolidated income statement

Year ended 30 September 2016

 

    Year ended     Year ended     Year ended  
    30 September     30 September     30 September  
    2016     2016     2015  
    $000’s     £000’s     £000’s  
Revenue     13,320       10,315       28,540  
Cost of sales     (3,511 )     (2,719 )     (2,618 )
Research and development expenditure     (128,889 )     (99,815 )     (76,785 )
Sales, general and administrative expenses     (25,747 )     (19,939 )     (12,569 )
Net foreign exchange gain     32,993       25,551       6,202  
Operating loss     (111,834 )     (86,607 )     (57,230 )
Other income     785       608       244  
Interest expense     (223 )     (173 )     (75 )
Loss before tax     (111,272 )     (86,172 )     (57,061 )
Tax benefit     29,073       22,515       12,498  
Loss for the year     (82,199 )     (63,657 )     (44,563 )
                         
Loss per share – basic and diluted     (30.4c )     (23.5p )     (18.1p )

 

All activities relate to continuing operations.

 

Condensed consolidated statement of comprehensive loss

For the year ended 30 September 2016

 

    Year ended
30 September
2016
£000’s
    Year ended
30 September
2015
£000’s
 
Loss for the year     (63,657 )     (44,563 )
Items that may be reclassified subsequently to profit or loss                
Exchange differences on translation of foreign operations     349       (71 )
Other comprehensive gain/(loss) for the year     349       (71 )
Total comprehensive loss for the year     (63,308 )     (44,634 )

 

 

 

 

GW Pharmaceuticals plc

Condensed consolidated statement of changes in equity

Year ended 30 September 2016

 

    Called-up     Share                    
    share     premium     Other     Accumulated     Total  
    capital     account     reserves     deficit     equity  
    £000’s     £000’s     £000’s     £000’s     £000’s  
Balance at 1 October 2014     237       220,551       19,260       (81,464 )     158,584  
Issue of share capital     22       127,812                   127,834  
Expense of new equity issue           (271 )                 (271 )
Exercise of share options     2       1,183                   1,185  
Share-based payment transactions                       2,488       2,488  
Loss for the year                       (44,563 )     (44,563 )
Deferred tax attributable to unrealized share option gains                       84       84  
Other comprehensive expense                 (71 )           (71 )
Balance at 30 September 2015     261       349,275       19,189       (123,455 )     245,270  
                                         
Balance at 1 October 2015     261       349,275       19,189       (123,455 )     245,270  
Issue of share capital     39       206,512                   206,551  
Expense of new equity issue           (472 )                 (472 )
Underwriters’ contribution towards expenses of new equity issue           472                   472  
Exercise of share options     2       690                   692  
Share-based payment transactions                       8,152       8,152  
Loss for the year                       (63,657 )     (63,657 )
Deferred tax attributable to unrealized share option gains                       1,133       1,133  
Other comprehensive expense                 349             349  
Balance at 30 September 2016     302       556,477       19,538       (177,827 )     398,490  

 

 

 

 

GW Pharmaceuticals plc

Condensed consolidated balance sheet

As at 30 September 2016

 

    As at 30
September
    As at 30
September
    As at 30
September
 
    2016     2016     2015  
    $000’s     £000’s     £000’s  
Non-current assets                        
Intangible assets - goodwill     6,728       5,210       5,210  
Other intangible assets     812       629       245  
Property, plant and equipment     50,291       38,947       28,733  
Deferred tax asset     5,001       3,873       418  
      62,832       48,659       34,606  
Current assets                        
Inventories     5,485       4,248       4,756  
Taxation recoverable     27,533       21,322       12,641  
Trade receivables and other assets     5,883       4,556       2,873  
Cash and cash equivalents     483,445       374,392       234,872  
      522,346       404,518       255,142  
                         
Total assets     585,178       453,177       289,748  
Current liabilities                        
Trade and other payables     (40,249 )     (31,170 )     (24,022 )
Current tax liabilities     (1,140 )     (883 )     (366 )
Obligations under finance leases     (272 )     (211 )     (111 )
Deferred revenue     (3,468 )     (2,686 )     (3,269 )
      (45,129 )     (34,950 )     (27,768 )
                         
Non-current liabilities                        
Trade and other payables     (12,168 )     (9,423 )     (8,445 )
Obligations under finance leases     (6,403 )     (4,959 )     (1,540 )
Deferred revenue     (6,915 )     (5,355 )     (6,725 )
Total liabilities     (70,615 )     (54,687 )     (44,478 )
Net assets     514,563       398,490       245,270  
                         
Equity                        
Share capital     390       302       261  
Share premium account     718,568       556,477       349,275  
Other reserves     25,229       19,538       19,189  
Accumulated deficit     (229,624 )     (177,827 )     (123,455 )
                         
Total equity     514,563       398,490       245,270  

 

 

 

 

GW Pharmaceuticals plc

Condensed consolidated cash flow statement

As at 30 September 2016

 

    Year ended     Year ended     Year ended  
    30 September 2016     30 September 2016     30 September 2015  
    $000’s     £000’s     £000’s  
Loss for the year     (82,199 )     (63,657 )     (44,563 )
Adjustments for:                        
Other income     (785 )     (608 )     (244 )
Interest expense     223       173       75  
Tax benefit     (29,073 )     (22,515 )     (12,498 )
Depreciation of property, plant and equipment     4,654       3,605       2,250  
Impairment of property, plant and equipment                 606  
Amortization of intangible assets     80       62       52  
Net foreign exchange gains     (32,993 )     (25,551 )     (6,282 )
Increase in provision for inventories     93       72       33  
Decrease in deferred signature fees     (1,511 )     (1,170 )     (1,250 )
Share-based payment charge     10,527       8,152       2,478  
Loss on disposal of property, plant and equipment     1       1       1  
      (130,983 )     (101,436 )     (59,342 )
Decrease/(increase) in inventories     563       436       (12 )
Increase in trade receivables and other assets     (972 )     (753 )     (1,010 )
Increase in trade and other payables and deferred revenue     6,148       4,761       8,478  
Cash used in operations     (125,244 )     (96,992 )     (51,886 )
Income taxes paid     (1,140 )     (883 )      
Research and development tax credits received     17,150       13,281       5,415  
Net cash outflow from operating activities     (109,234 )     (84,594 )     (46,471 )
Investing activities                        
Interest received     560       434       236  
Purchases of property, plant and equipment     (11,206 )     (8,678 )     (17,915 )
Purchase of intangible assets     (661 )     (512 )     (114 )
Proceeds from sales of property, plant and equipment                 2  
Net cash outflow from investing activities     (11,307 )     (8,756 )     (17,791 )
Financing activities                        
Proceeds on exercise of share options     697       540       1,185  
Proceeds of new equity issue     266,714       206,550       127,834  
Expenses of new equity issue     (412 )     (319 )     (271 )
Underwriters’ contribution towards expenses of new equity issue     609       472        
Interest paid     (89 )     (69 )     (74 )
Repayments of advance funding     (310 )     (240 )      
Repayments of obligations under finance leases     (164 )     (127 )     (255 )
Net cash inflow from financing activities     267,045       206,807       128,419  
Effect of foreign exchange rate changes on cash and cash equivalents     33,655       26,063       6,224  
Net increase in cash and cash equivalents     180,159       139,520       70,381  
Cash and cash equivalents at beginning of the year     303,286       234,872       164,491  
Cash and cash equivalents at end of the year     483,445       374,392       234,872  

 

 

 

 

Exhibit 99.2

 

 

GW Announces New Epidiolex ® (CBD) Positive Phase 3 Data in Dravet Syndrome and Lennox-Gastaut Syndrome

- Posters Presented at American Epilepsy Society Annual Meeting -

- New data includes key secondary efficacy endpoints -

 

London, UK, 5 Dec 2016:  GW Pharmaceuticals plc (Nasdaq: GWPH, , “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced additional positive Epidiolex ® (cannabidiol or CBD) Phase 3 data in poster presentations at the 70 th Annual Meeting of the American Epilepsy Society. These data are from the positive pivotal Phase 3 study of Epidiolex in Dravet syndrome and the first pivotal Phase 3 study of Epidiolex in Lennox-Gastaut syndrome (LGS),both reported earlier this year.

 

“We are pleased to present key findings from two pivotal Phase 3 studies of Epidiolex and believe these additional positive data reinforce the robust nature of the results achieved in two of the most difficult-to-treat epilepsy patient populations,” stated Justin Gover, GW’s Chief Executive Officer. “We are making very good progress toward a NDA submission to the FDA as well as preparations for commercial launch and look forward to the opportunity to make this important new medicine available to patients as quickly as possible.”

 

Highlights of Findings in both Phase 3 studies:

· Each pivotal Phase 3 study achieved the primary endpoint demonstrating a statistically significant difference between Epidiolex and placebo in seizure frequency reduction during the 14 week treatment period.
· In the 12-week maintenance period (excluding the initial dose escalation), the treatment effect increased for patients receiving Epidiolex and showed a greater level of statistically significance compared with placebo.
· Caregivers of patients receiving Epidiolex were significantly more likely to report an improvement in overall condition,
· A consistent separation between Epidiolex and placebo across all response rates was seen. In the LGS study, the drop seizure responder analysis showed a statistically-significant separation between Epidiolex and placebo at the 50 percent seizure reduction threshold,
· Epidiolex efficacy was established relatively early in treatment.
· Epidiolex was generally well tolerated.

 

 

 

 

“These placebo-controlled studies demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile”, stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator of the Dravet syndrome trial. “The epilepsy community has been eagerly anticipating the presentation of this high quality scientific data from the Epidiolex program at the American Epilepsy Society. My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”

 

“Dravet syndrome and Lennox-Gastaut syndrome are diagnosed in early childhood and represent some of the most difficult types of epilepsy to treat. Nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime. These trial results show that Epidiolex offers much needed new hope for children and their families,” stated Elizabeth Thiele, MD, PhD, Director of Pediatric Epilepsy at the Massachusetts General Hospital, Professor of Neurology at the Harvard Medical School and Principal Investigator of the LGS trial. “I very much look forward to the day when Epidiolex is available as a new prescription option for my patients.”

 

The studies represented in the posters are the first randomized, double-blind, placebo-controlled studies to investigate the efficacy and safety of CBD added to concomitant antiepileptic drug (AED) therapy in Dravet syndrome and LGS. The following are links to the posters presented:

 

Phase 3 Trial in Lennox-Gastaut syndrome (click to access)

Phase 3 Trial in Dravet syndrome (Part A) (click to access)

Phase 3 Trial in Dravet syndrome (Part B) (click to access)

Copies of these posters will also be available on GW’s corporate website in the Investor Relations section under presentations.

 

About Lennox-Gastaut Syndrome

 

The peak onset of LGS typically occurs between ages of 3 to 5 years and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In up to 30 percent of patients, no cause can be found. Patients with LGS commonly have multiple seizure types including non-convulsive, convulsive and drop seizures, which frequently lead to falls and injuries. Drug resistance is one of the main features of LGS. Most children with LGS experience some degree of impaired intellectual functioning, as well as developmental delays and behavioral disturbances. It is estimated that there are approximately 14,000-18,500 patients with LGS in the United States and 23,000-31,000 patients with LGS in Europe.

 

About Dravet Syndrome

 

Dravet syndrome is a severe infantile-onset and highly treatment-resistant epileptic syndrome frequently associated with a genetic mutation in sodium channels. Onset of Dravet syndrome occurs during the first year of life in previously healthy and developmentally normal infants. Initial seizures are often temperature related, severe, and long-lasting. Over time, people with Dravet syndrome can develop multiple types of seizures, including tonic-clonic, myoclonic, and atypical absences and are prone to bouts of prolonged seizures called status epilepticus, which can be life threatening. Risk of premature death including SUDEP (sudden expected death in epilepsy) is elevated in people with Dravet Syndrome. Additionally, the majority will develop moderate to severe intellectual and development disabilities and require lifelong supervision and care. There are currently no FDA-approved treatments and nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime.

 

 

 

 

About Epidiolex

 

Epidiolex, GW’s lead cannabinoid product candidate, is a liquid formulation of pure plant-derived CBD, which is in development for the treatment of a number of rare pediatric epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models and has the ability to treat seizures in acute animal models of epilepsy with significantly fewer side effects than existing anti-epileptic drugs. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex in the treatment of both Dravet syndrome and Lennox-Gastaut syndrome. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.

 

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), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, 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. In the United States, GW is operating as Greenwich Biosciences Inc. For further information, please visit www.gwpharm.com.

 

Forward-looking statements

 

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company's investigational drug Epidiolex®, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. 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 the 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, uncertainties and other risks 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.

 

 

 

 

Enquiries:

 

GW Pharmaceuticals plc  
Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
   
Sam Brown, Inc.  
Amanda Foley 610-725-0725 / 610-585-9400

 

 

 

 

 

Cannabidiol (CBD) Significantly Reduces Drop Seizure Frequency in Lennox-Gastaut Syndrome (LGS): Results of a Multi-center, Randomized, Double-blind, Placebo-controlled Trial (GWPCARE4) Elizabeth A. Thiele1 | Maria Mazurkiewicz-Beldzinska2 | Selim Benbadis3 | Eric D. Marsh4 | Charuta Joshi5 | Jacqueline A. French6 | Claire Roberts7 | Adam Taylor7 | Kenneth Sommerville8 1Massachusetts General Hospital, USA; 2Medical University of Gdansk, Poland; 3University of South Florida, USA; 4Children’s Hospital of Philadelphia, USA; 5Childrens Hospital of Colorado, USA; 6NYU Langone Medical Center, USA; 7GW Research, Ltd, England; 8GW Pharmaceuticals Inc., Duke University, USA. SUMMARY • The trial met its primary endpoint, demonstrating that CBD (20 mg/kg/day), as an add-on to standard of care, produced significantly greater reductions in drop seizures vs. placebo in patients with Lennox-Gastaut Syndrome (LGS). • CBD resulted in significantly greater reductions in total seizure and non-drop seizure frequency vs. placebo. • CBD patients/caregivers were significantly more likely than patients taking placebo to report an improvement in overall condition as measured on the Subject/Caregiver Global Impression of Change (S/CGIC) scale. • CBD resulted in more adverse events than placebo, but it was generally well tolerated. INTRODUCTION Data from an open-label, expanded access program in the United States have suggested that CBD reduces seizures in patients with LGS1. This is the first randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of adjunctive CBD in children and adults (2–55 years old) with LGS. Patient disposition and baseline demographics *Met criteria for liver enzyme elevations Parameter CBD (n=86) Placebo (n=85) Age (years) Mean 15.5 15.3 (min, max) (2.7, 39.0) (2.8, 45.1) 2–17 years [n (%)] 56 (65.1) 57 (67.1) 18–55 years [n (%)] 30 (34.9) 28 (32.9) Sex [n (%)] Male 45 (52.3) 43 (50.6) Number of Prior AEDs Median 6 6 (min, max) (1, 18) (0, 28) Number of Current AEDs* Median 3 3 (min, max) (1, 5) (1, 4) Seizure Frequency (per 28 Days) During Baseline Median Drop Seizures 71 75 (Q1, Q3) (27.0, 156.0) (47.3, 144.0) Median Total Seizures 145 177 (Q1, Q3) (72.0, 385.7) (68.6, 359.5) *Most common antiepileptic drugs (AEDs) were clobazam (49%), valproic acid (40%), and lamotrigine (37%). EFFICACY RESULTS Percentage change from baseline in drop and total seizure frequency (28-day average) A | Drop Seizures CBD (n=86) B | Total Seizures CBD (n=86) Placebo (n=85) Placebo (n=85) Significantly greater reductions were reported for CBD than for placebo; this difference was established during the first 4 weeks of maintenance. Reduction in non-drop seizures was statistically different for the subgroup of patients who had non-drop seizures: CBD (n=77; 49%) vs. placebo (n=79; 23%) (p=0.0044). Subject/caregiver global impression of change from Drop seizure responder rates baseline at last visit 44.2% of CBD patients had >50% reduction in drop seizures compared to 23.5% of patients taking placebo (p=0.0043). No patients in either treatment group were drop-seizure free during the treatment period; 5 CBD patients vs. 0 placebo patients were drop-seizure free during the maintenance period, 3 of whom completed the trial. CBD patients/caregivers were more likely to report an improvement in overall condition in the S/CGIC (OR=2.54; p=0.0008). 94% of patients were on multiple concomitant AEDs. The effect of concomitant AEDs on efficacy will be explored in future pooled analyses. SAFETY RESULTS Summary of treatment-emergent adverse events (TEAEs) CBD (n=86) Placebo (n=85) n (%) n (%) All-causality TEAEs 74 (86.0%) 59 (69.4%) Treatment-related TEAEs 53 (61.6%) 29 (34.1%) TEAEs leading to withdrawal 12 (14.0%) 1 (1.2%) Serious TEAEs 20 (23.3%) 4 (4.7%) Treatment-related serious TEAEs 9 (10.5%) 1 (1.2%) TEAEs reported in >10% of patients in either group by preferred term Diarrhea 16 (18.6%) 7 (8.2%) Somnolence 13 (15.1%) 8 (9.4%) Pyrexia 11 (12.8%) 7 (8.2%) Decreased appetite 11 (12.8%) 2 (2.4%) Vomiting 9 (10.5%) 14 (16.5%) Of those who reported a TEAE, 78% of CBD and 97% of placebo patients reported it as mild or moderate. The pattern of serious TEAEs was consistent with the common TEAEs reported on CBD. There was no difference in the number of patients who experienced status epilepticus between CBD (n=1) and placebo (n=1); no episodes were deemed treatment-related nor led to withdrawal from treatment. There was 1 death in the CBD group, due to acute respiratory distress syndrome; the death was not considered treatment-related. Laboratory investigations Increases in ALT or AST (> 3× ULN) occurred in 1 placebo and 20 CBD patients; 16 CBD patients were on concomitant valproic acid. No patients met standard criteria for drug-induced liver injury (Hy’s law) with concurrent elevated bilirubin >2× ULN. Six CBD patients withdrew from treatment. A seventh patient met criteria for withdrawal but was discontinued for noncompliance. All elevations resolved. METHODS Eligible patients were aged 2–55 years with a clinical diagnosis of LGS inadequately controlled by >1 current AED(s). Patients had a history of slow (<3 Hz) spike-and-wave pattern EEG.After a 4-week baseline, patients with at least 2 drop seizures per week were randomized (1:1) to 20 mg/kg/day of a pharmaceutical formulation of CBD (100 mg/mL) in oral solution or matched placebo, administered b.i.d. starting at 2.5 mg/kg/day and titrated up to 20 mg/kg/day over a 2-week period, followed by a 12-week dose-maintenance period.A drop seizure was defined as an atonic, tonic, or tonic-clonic seizure involving the entire body, trunk, or head that led (or could have led) to a fall, injury, slumping in a chair, or hitting the patient’s head on a surface.The treatment period consisted of both the titration and maintenance periods.Caregivers recorded seizures daily using an automated interactive voice response system. Classification of seizure types was confirmed by the Epilepsy Study Consortium. Patients who completed the trial were eligible to continue into an open-label extension study. Disclosures: This study was sponsored by GW Pharmaceuticals plc, London, UK. Formatting and editorial assistance was provided to the authors by Hospicom, Cold Spring, NY and funded by GW Pharmaceuticals. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Elizabeth A. Thiele, Maria Mazurkiewicz-Beldzinska, Selim Benbadis, Eric D. Marsh, Charuta Joshi, and Jacqueline A. French have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, plc. Kenneth Sommerville is an employee of GW Pharmaceuticals, Inc. Adam Taylor and Claire Roberts are employees of GW Research, Ltd. Findings reported in this study are specific to GW Pharmaceuticals’ formulation of cannabidiol and cannot be extrapolated to other cannabidiol products. References: 1. Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2015;4422(15):1–9. Contact Information: medinfo.usa@gwpharm.com Presented: The American Epilepsy Society Annual Meeting; Houston, TX; December 2–6, 2016. To obtain a PDF of this poster • Scan the QR code or • Visit www.GWQRcodes.com/631138 Charges may apply. No personal information is stored.

 

 

 

 

 

A Dose Ranging Safety and Pharmacokinetic Study of Cannabidiol (CBD) in Children With Dravet Syndrome (GWPCARE1) Matthew H. Wong1 | Orrin Devinsky2 | Elizabeth A. Thiele3 | Richard Appleton4 | Anup D. Patel5 | Cynthia L. Harden6 | Kenneth Sommerville7 | Sam Greenwood8 | Gilmour Morrison8 1Wake Forest School of Medicine; 2NYU Epilepsy Center; 3Massachusetts General Hospital; 4Alder Hey Children’s Health Park; 5Nationwide Children’s Hospital and The Ohio State University College of Medicine; 6Mount Sinai Health System; 7GW Pharmaceuticals, Inc. and Duke University; 8GW Research, Ltd. SUMMARY • Exposure to CBD and its metabolites increased in a dose-proportional manner; 7-COOH-CBD was the major circulating metabolite. • N-desmethylclobazam (N-CLB) levels increased in patients on CBD, except for those on concomitant stiripentol, which may reflect prior saturated inhibition of CYP2C19 enzyme by stiripentol. • There was no demonstrable effect on other antiepileptic drugs (AEDs) tested (valproic acid, topiramate, stiripentol, or levetiracetam). • CBD resulted in more adverse events than placebo, but it was generally well tolerated at all doses examined. • 20 mg/kg/day was approved by the Data Safety Monitoring Committee for further investigation. INTRODUCTION Data from a US expanded access program suggest that CBD reduces seizures in patients with Dravet syndrome (DS)1. This randomized controlled study evaluated dose-ranging safety, tolerability, and pharmacokinetics (PK) of adjunctive CBD in children with DS in Part A. Data from Part A were used to determine the dose for Part B, which assessed safety and efficacy in a larger population. Patient disposition and baseline demographics *Met criteria for liver enzyme elevations CBD Parameter 5 mg/kg (n=10) 10 mg/kg (n=8) 20 mg/kg (n=9) Placebo (n=7) Age (years) Mean 7.2 7.4 8.7 7.0 (min, max) (4.7, 10.9) (4.0, 10.9) (5.4, 10.7) (6.1, 8.8) Sex Male (%) 5 (50) 3 (38) 3 (33) 5 (71) Number of Prior AEDs Median 3 3.5 4 5 (min, max) (0, 11) (0, 5) (2, 8) (1, 5) Number of Current AEDs* Median 3 3 3 2 (min, max) (1, 4) (2, 3) (1, 4) (1, 3) *The most commonly used AEDs were clobazam (68%) and valproic acid (65%). PHARMACOKINETIC RESULTS Plasma pharmacokinetics of CBD and metabolites CBD 6-OH-CBD 7-COOH-CBD Day 1: 5 mg/kg* Day 1: 10 mg/kg* Day 1: 20 mg/kg* Day 22: 5 mg/kg Day 22: 10 mg/kg Day 22: 20 mg/kg *Day 1 dose was 1.25 mg/kg for all 3 treatment groups CBD 6-OH-CBD 7-COOH-CBD Individual patient data Geometric mean Mean percentage change in plasma concentrations of CLB, N-CLB, and valproic acid at Day 22 CLB and N-CLB Valproic Acid *2 patients in the 5 mg/kg group reduced CLB dose during the treatment period. Error bars: standard error of mean (SEM) Error bars: SEM After single or twice-daily dosing of CBD, 7-COOH-CBD was the major circulating metabolite; by Day 22 it was approximately 13–17 times higher than CBD; 6-OH-CBD was a minor circulating metabolite. Exposure to CBD, 7-COOH-CBD, and 6-OH-CBD increased in a dose-proportional manner; qualitative data generated for the 7-OH-CBD metabolite also showed a dose-proportional increase. In patients on concomitant CLB, at Day 22, CLB plasma concentrations were unchanged; N-CLB concentration increased independent of CBD dose but did not increase in the patients on stiripentol. CBD had no obvious effect on drug levels of other AEDs tested: valproic acid (n=18), topiramate (n=8), stiripentol (n=4), or levetiracetam (n=7). SAFETY RESULTS Treatment-emergent adverse events (TEAEs) 5 mg/kg (n=10) 10 mg/kg (n=8) 20 mg/kg (n=9) Placebo (n=7) n (%) n (%) n (%) n (%) All-causality TEAEs 8 (80) 5 (63) 7 (78) 6 (86) Treatment-related TEAEs 6 (60) 3 (38) 4 (44) 1 (14) TEAEs leading to withdrawal 0 1 (13) 1 (11) 0 Serious TEAEs 1 (10) 2 (25) 1 (11) 1 (14) Treatment-related serious TEAEs 1 (10) 1 (13) 0 0 TEAEs reported in >10% of patients in either group by preferred term Somnolence 2 (20) 3 (38) 0 1 (14) Pyrexia 3 (30) 3 (38) 0 0 Decreased appetite 0 1 (13) 4 (44) 0 Sedation 2 (20) 0 2 (22) 0 2 patients on CBD discontinued due to TEAEs (1 for abnormal liver enzymes meeting withdrawal criteria and decreased appetite on 20 mg/kg, and 1 for pyrexia and maculopapular rash on 10 mg/kg); each event was considered treatment-related but resolved following cessation of CBD. Increases in ALT or AST (levels > 3× ULN) occurred in 6 CBD patients, all on valproic acid (4 had concomitant infections). No patients met standard criteria for drug-induced liver injury (Hy’s law) with concurrent elevated bilirubin > 2× ULN. One patient withdrew from treatment. All elevations resolved. METHODS Patients were aged 4–10 years and had a documented history of DS with seizures inadequately controlled by >1 current AED(s). After a 4-week baseline period, patients with fewer than 4 convulsive seizures (ie, tonic–clonic, tonic, clonic, atonic seizures) were randomized to 1 of 3 doses of CBD (5, 10, 20 mg/kg/day) or placebo as add-on therapy for 3 weeks. CBD (25 or 100 mg/mL oral solution) was administered b.i.d. starting at 2.5 mg/kg/day and increasing by 2.5–5.0 mg/kg QOD to randomized dose. The treatment period consisted of both the titration and maintenance periods. PK blood samples were taken on the first day of dosing and again at 3 weeks (nominal times: pre-dose; 2.5 h and 5 h post-dose); PK exposures were expressed as AUC0–t; dose proportionality was assessed on Day 22 by simple regression analysis. An independent Data Safety Monitoring Committee reviewed unblinded safety data during Part A of the trial in order to recommend the dose and dose regimen to be used in Part B. Classification of seizure types was confirmed by the Epilepsy Study Consortium. Patients who completed the trial were eligible to continue into an open-label extension study. Disclosures: This study was sponsored by GW Pharmaceuticals plc, London, UK. Formatting and editorial assistance was provided to the authors by Hospicom, Cold Spring, NY and funded by GW Pharmaceuticals. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Matthew H. Wong, Orrin Devinsky, Elizabeth A. Thiele, Richard Appleton, Anup D. Patel, and Cynthia L. Harden have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, plc. Ken Sommerville is an employee of GW Pharmaceuticals, Inc. Sam Greenwood and Gilmour Morrison are employees of GW Research, Ltd. Findings reported in this study are specific to GW Pharmaceuticals’ formulation of cannabidiol and cannot be extrapolated to other cannabidiol products. References: 1. Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2015;4422(15):1–9. Contact Information: medinfo.usa@gwpharm.com Presented: The American Epilepsy Society Annual Meeting; Houston, TX; December 2–6, 2016. To obtain a PDF of this poster • Scan the QR code or • Visit www.GWQRcodes.com/519903 Charges may apply. No personal information is stored.

 

 

 

 

Cannabidiol (CBD) Significantly Reduces Convulsive Seizure Frequency in Dravet Syndrome (DS): Results of a Multi-center, Randomized, Double-blind, Placebo-controlled Trial (GWPCARE1) J. Helen Cross1 | Orrin Devinsky2 | Linda Laux3 | Eric Marsh4 | Ian Miller5 | Rima Nabbout6 | Ingrid E Scheffer7 | Elizabeth A. Thiele8 | Stephen Wright9 1UCL Great Ormond Street Institute of Child Health, London, UK; 2NYU Comprehensive Epilepsy Center, New York, NY; 3Ann and Robert H Lurie Children’s Hospital of Chicago, Lurie Children’s Epilepsy Center, Chicago, Illinois; 4The Children’s Hospital of Philadelphia, Philadelphia PA; 5Miami Children’s Hospital, Miami, Florida; 6Hôpital Necker - Enfants Malades, Paris, France; 7University of Melbourne, Florey Institute, Austin Health and Royal Children’s Hospital, Melbourne, Australia; 8Massachusetts General Hospital, Boston, MA; 9GW Research, Ltd, London, England. SUMMARY • The trial met its primary endpoint, demonstrating that CBD (20 mg/kg/day), as an add-on to standard of care, produced significantly greater reductions in convulsive seizures vs. placebo in patients with Dravet syndrome (DS). • CBD resulted in significantly greater reductions in total seizure frequency vs. placebo. • Compared to placebo, CBD caregivers were significantly more likely to report an improvement in overall condition, as measured on the Caregiver Global Impression of Change (CGIC) scale. • CBD resulted in more adverse events than placebo, but it was generally well tolerated. INTRODUCTION Data from a US expanded access program suggest that CBD reduces seizures in patients with DS1. This is the first randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of adjunctive CBD in children (2–18 years old) with DS. Patient disposition and baseline demographics Parameter CBD (n=61) Placebo (n=59) Age (years) Mean 9.7 9.8 (min, max) (2.5, 18.0) (2.3, 18.4) Age Group [n (%)] 2–5 years 18 (29.5) 17 (28.8) 6–12 years 23 (37.7) 24 (40.7) 13–18 years 20 (32.8) 18 (30.5) Sex [n (%)] Male 35 (57.4) 27 (45.8) Number of Prior AEDs Median 4 4 (min, max) (0, 26) (0, 14) Number of Current AEDs* Median 3 3 (min, max) (1, 5) (1, 5) Seizure Frequency (per 28 Days) During Baseline Median Convulsive 12.4 14.9 (Q1, Q3) (6.2, 28.0) (7.0, 36.0) Median Total 24 41.5 (Q1, Q3) (10.4, 141.0) (12.0, 367.0) *Most common antiepileptic drugs (AEDs) were clobazam (65%), valproic acid (57%), stiripentol (43%). EFFICACY RESULTS Percentage change in convulsive and total seizure frequency (28-day average) A | Convulsive Seizures B | Total Seizures CBD (n=61) CBD (n=61) Placebo (n=59) Placebo (n=59) Significantly greater reductions were reported for CBD than for placebo; this difference was established during the first 4 weeks of maintenance. Reduction in non-convulsive seizures was not statistically different for subgroup of patients with non-convulsive seizures who were taking CBD (n=37, 40%) vs. placebo (n=41, 35%). Caregiver global impression of change from Convulsive seizure responder rates baseline at last visit 43% of CBD patients had a >50% reduction in convulsive seizures compared to 27% of patients taking placebo. 3 CBD and no placebo patients achieved convulsive and total seizure freedom during the entire treatment period. An additional 4 CBD patients achieved convulsive seizure freedom during maintenance (no placebo); of these, 1 completed the trial. Caregivers of CBD patients were more likely to report an improvement in overall condition on CGIC (OR=2.29; p=0.0155). 93% of patients were on multiple concomitant AEDs. The effect of concomitant AEDs on efficacy will be explored in future pooled analyses. SAFETY RESULTS Summary of treatment-emergent adverse events (TEAEs) CBD (n=61) Placebo (n=59) n (%) n (%) All-causality TEAEs 57 (93.4%) 44 (74.6%) Treatment-related TEAEs 43 (70.5%) 16 (27.1%) TEAEs leading to withdrawal 9 (14.8%) 1 (1.7%) Serious TEAEs 10 (16.4%) 3 (5.1%) Treatment-related serious TEAEs 5 (8.2%) 0 TEAEs reported in >10% of patients in either group by preferred term Somnolence 22 (36.1%) 6 (10.2%) Diarrhea 19 (31.1%) 6 (10.2%) Decreased appetite 17 (27.9%) 3 (5.1%) Fatigue 12 (19.7%) 2 (3.4%) Pyrexia 9 (14.8%) 5 (8.5%) Vomiting 9 (14.8%) 3 (5.1%) Lethargy 8 (13.1%) 3 (5.1%) Upper respiratory tract infection 7 (11.5%) 5 (8.5%) Convulsion 7 (11.5%) 3 (5.1%) Of those who reported a TEAE, 84% of CBD and 95% of placebo patients reported it as mild or moderate. The pattern of serious TEAEs was consistent with the common TEAEs reported on CBD. There was no difference in the number of patients who experienced status epilepticus between CBD (n=4) and placebo (n=3); no episodes were deemed treatment-related nor led to withdrawal from treatment. There were no deaths. Laboratory investigations Increases in ALT or AST (> 3× ULN) occurred in 12 CBD and 1 placebo patient, all of whom were on concomitant valproic acid. No patients met standard criteria for drug-induced liver injury (Hy’s law) with concurrent elevated bilirubin > 2× ULN. Three of the CBD patients withdrew from treatment. All elevations resolved. METHODS Eligible patients were aged 2–18 years, with a clinical diagnosis of DS inadequately controlled by >1 current AED(s), and were experiencing >4 convulsive seizures during the 28-day baseline period. Patients were randomized (1:1) to 20 mg/kg/day of a pharmaceutical formulation of CBD (100 mg/mL) in oral solution or matched placebo, administered b.i.d. starting at 2.5 mg/kg/day and titrated up to 20 mg/kg/day over a 2-week period, followed by a 12-week dose maintenance period. Convulsive seizures were defined as tonic–clonic, tonic, clonic, and atonic seizures. The treatment period consisted of both the titration and maintenance periods. Caregivers recorded seizures daily using an automated interactive voice response system. DS diagnosis and classification of seizure types was confirmed by the Epilepsy Study Consortium. Patients who completed the trial were eligible to continue into an open-label extension study. Disclosures: This study was sponsored by GW Pharmaceuticals plc, London, UK. Formatting and editorial assistance was provided to the authors by Hospicom, Cold Spring, NY and funded by GW Pharmaceuticals. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. J. Helen Cross, Orrin Devinsky, Linda Laux, Eric Marsh, Ian Miller, Rima Nabbout, Ingrid E Scheffer, and Elizabeth A. Thiele have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, plc. Stephen Wright is an employee of GW Research, Ltd. Findings reported in this study are specific to GW Pharmaceuticals’ formulation of cannabidiol and cannot be extrapolated to other cannabidiol products. References: 1. Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2015;4422(15):1–9. Contact Information: medinfo.usa@gwpharm.com Presented: The American Epilepsy Society Annual Meeting; Houston, TX; December 2–6, 2016. To obtain a PDF of this poster • Scan the QR code or • Visit www.GWQRcodes.com/311151 Charges may apply. No personal information is stored.