UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

 Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): May 6, 2019

 

GW PHARMACEUTICALS PLC 

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

England and Wales
(State or other jurisdiction of incorporation)
001-35892
(Commission File Number)
N/A
(I.R.S. Employer Identification No.)

 

Sovereign House, Vision Park Chivers Way, Histon Cambridge, CB24 9BZ United Kingdom
(Address of Principal Executive Offices, including Zip Code)

 

Telephone: +44 1223 266 800
(Registrant’s Telephone Number, Including Area Code)

 

N/A
(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging Growth Company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section13(a) of the Exchange Act ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
American Depositary Shares, each representing 12 Ordinary Shares, par value £0.001 per share   GWPH   The Nasdaq Global Market

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 6, 2019, GW Pharmaceuticals plc (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2019. The full text of the press release and the related attachment are furnished as Exhibit 99.1 hereto and incorporated by reference herein.

 

The information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

 

Item 8.01. Other Events

 

On May 6, 2019, the Company issued a press release announcing positive results in a pivotal Phase 3 trial for Epidiolex®. A copy of the press release is attached as Exhibit 99.2 hereto and incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit Number   Exhibit Description
     
99.1   Press Release, dated May 6, 2019, “GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2019.”
     
99.2   Press Release, dated May 6, 2019, “GW Pharmaceuticals Reports Positive Phase 3 Pivotal Trial Results for EPIDIOLEX® (cannabidiol) Oral Solution in Patients with Seizures Associated With Tuberous Sclerosis Complex.”

  

 

 

 

SIGNATURE

 

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

 

Dated: May 6, 2019 GW PHARMACEUTICALS PLC
     
  By: /s/ Douglas B. Snyder
    Name: Douglas B. Snyder
    Title: Chief Legal Officer

 

 

 

 

 

 

Exhibit 99.1

 

 

 

 

 

GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2019

 

- Epidiolex U.S. Q1 net sales of $33.5m -

- Positive Phase 3 pivotal results in Tuberous Sclerosis Complex, sNDA submission expected in Q4 2019 -

- Conference call today at 4:30 p.m. EST -

 

Carlsbad, CA, May 6, 2019: GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development and commercialization of cannabinoid prescription medicines, announces financial results for the first quarter ended March 31, 2019.

 

“We are pleased to report a strong launch of Epidiolex in the US and continue to be encouraged by the level of support for this medicine from patients, caregivers and healthcare professionals. As the first and only plant-derived CBD medicine approved by the FDA, Epidiolex offers a novel treatment option for patients with Lennox-Gastaut Syndrome and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy”, stated Justin Gover, GW’s Chief Executive Officer. “In addition, we are delighted to report today positive results from a Phase 3 trial in patients with seizures associated with Tuberous Sclerosis Complex, and are excited at the prospect of expanding the use of Epidiolex to these high need patients in the future.”

 

OPERATIONAL HIGHLIGHTS

·Darren Cline appointed U.S. Chief Commercial Officer
·Epidiolex® (cannabidiol)
oU.S. commercial update
§Q1 Net sales of $33.5m
§Over 7,600 patients have received Epidiolex prescriptions since launch
§Over 1,900 physicians have generated dispensed prescriptions since launch
§Pharmacy distribution network now includes over 145 distribution points
§Approximately 75 percent of 900 patients in expanded access program and open label extension now transitioned to commercial product. Remaining patients expected to transition by end of Q2.
oRapid and encouraging payor coverage decisions
§Over 90 percent of all U.S. lives now covered – 65 percent of which have either Prior Authorization (PA) to indication or less restrictive
§New commercial coverage determination recently announced by United HealthCare, OptumRx and Prime Therapeutics
§99 percent of State Fee-for-Service Medicaid lives now have a coverage determination with 67 percent of covered lives having either PA to indication or less restrictive
·7 States covering Epidiolex without restrictions
§Approximately 90 percent of Managed Medicaid lives have a coverage determination with 40 percent having a PA to indication or less restrictive
oTarget physician coverage
§The sales organization has to date interacted with about 70 percent of the over 5,000 target healthcare professionals including all Level 3 and 4 epilepsy centers
oEuropean regulatory and pre-launch progress
§CHMP opinion expected mid-2019

 

 

 

 

§Launches expected in major five European markets by end of 2019
oManufacturing
§Commercial manufacturing and supply chain running smoothly
§Production capacity sufficient to meet expected demand in both U.S. and Europe
oClinical trials
§Positive results in Phase 3 trial in Tuberous Sclerosis Complex
·Primary efficacy measure achieved with both Epidiolex doses compared to placebo
·sNDA submission expected in Q4 2019
§IND open for pivotal Phase 3 trial in Rett Syndrome with expected start in Q2 2019
oLife-cycle management
§Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation
·PK data expected in 2019
oExclusivity
§7 years of orphan exclusivity confirmed by FDA, plus 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe plus 2 year pediatric extension
§Key favorable patent grants by USPTO related to the use of CBD in epilepsy
·Patents align directly with new Epidiolex FDA label and listed in “Orange Book”
·Patent expiry dates to 2035
§Additional patent applications under review, including patents related to the use of Epidiolex in TSC
·Pipeline progress
oSativex® (nabiximols)
§FDA meeting in December 2018 resulted in regulatory pathway in the U.S.
·Initial U.S. target indication: Multiple Sclerosis spasticity
·Single Phase 3 pivotal study expect to commence in Q4 2019
§Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
oCBDV
§Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population
§Company sponsored IND open for 30-patient open label study in autism
§Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder has commenced recruitment
§Open label study in Rett syndrome and seizures has commenced

 

FINANCIAL HIGHLIGHTS

 

·Cash and cash equivalents at March 31, 2019 were $521.7 million compared to $591.5 million as of December 31, 2018
·Revenue for the quarter ended March 31, 2019 was $39.2 million compared to $3.0 million for the quarter ended March 31, 2018
·Net loss for the quarter ended March 31, 2019 was $50.1 million compared to $69.5 million for the quarter ended March 31, 2018
·Closed transaction to sell Rare Pediatric Disease Priority Review Voucher for $105 million on April 5, 2019. The sale will be reflected in our Q2 2019 results

 

 

 

 

 

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending March 31, 2019 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 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 47716.

 

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, along with its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA approval for EPIDIOLEX (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older and which is now available by prescription in the U.S. The Company has submitted a regulatory application in Europe for the adjunctive treatment of seizures associated with LGS and Dravet syndrome. The company continues to evaluate EPIDIOLEX in additional rare epilepsy conditions including Tuberous Sclerosis Complex (TSC) andRett 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 planning a U.S. Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. 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) oral solution and Sativex (nabiximols) and the safety profile and commercial potential of EPIDIOLEX and Sativex. 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 10-KT filed on 26 February 2019. 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

 

EU Media Enquiries:

FTI Consulting

 
Ben Atwell/Andrew Ward +44 (0) 20 727 1000

  

 

 

  

GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited) 

 

   March 31,   December 31, 
   2019   2018 
Assets          
Cash and cash equivalents  $521,669   $591,497 
Accounts receivable, net   19,251    4,192 
Inventory   48,559    33,030 
Prepaid expenses and other current assets   19,389    17,903 
Total current assets   608,868    646,622 
Property, plant, and equipment, net   102,029    90,832 
Operating lease assets   20,077     
Goodwill   6,959    6,959 
Deferred tax assets   8,584    8,720 
Other assets   3,040    2,935 
Total assets  $749,557   $756,068 
Liabilities and stockholders’ equity          
Accounts payable  $10,794   $9,796 
Accrued liabilities   59,782    52,477 
Current tax liabilities   1,730    2,384 
Other current liabilities   5,651    1,559 
Total current liabilities   77,957    66,216 
Long-term liabilities:          
Finance lease liabilities   5,801    5,690 
Operating lease liabilities   16,374     
Other liabilities   9,696    10,082 
Total long-term liabilities   31,871    15,772 
Total liabilities   109,828    81,988 
Commitments and contingencies          
Stockholders’ equity:          
Ordinary shares par value £0.001; 368,613,440 shares
outstanding as of March 31, 2019; 366,616,688 shares
outstanding as of December 31, 2018
   567    564 
Additional paid-in capital   1,593,056    1,581,144 
Accumulated deficit   (879,004)   (828,940)
Accumulated other comprehensive loss   (74,890)   (78,688)
Total stockholders’ equity   639,729    674,080 
Total liabilities and stockholders’ equity  $749,557   $756,068 

 

 

 

 

GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(unaudited)

 

   Three Months Ended March 31, 
   2019   2018 
Revenues        
Product net sales  $38,974   $2,812 
Other revenue   273    229 
Total revenues   39,247    3,041 
Operating expenses          
Cost of product sales   5,131    1,625 
Research and development   30,375    43,485 
Selling, general and administrative   55,078    26,173 
Total operating expenses   90,584    71,283 
Loss from operations   (51,337)   (68,242)
Interest income   2,087    759 
Interest expense   (265)   (325)
Foreign exchange loss   (1,114)   (640)
Loss before income taxes   (50,629)   (68,448)
Income tax (benefit) expense   (565)   1,013 
Net loss  $(50,064)  $(69,461)
           
Net loss per common share, basic and diluted  $(0.14)  $(0.20)
           
Weighted average common shares outstanding, basic and diluted   369,823    340,252 

 

 

 

 

 

 

GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

   Three Months Ended March 31, 
   2019   2018 
Cash flows from operating activities          
Net loss  $(50,064)  $(69,461)
Adjustments to reconcile net loss to net cash used in operating activities:          
Foreign exchange loss   797    873 
Stock-based compensation   11,142    6,859 
Depreciation and amortization   2,417    2,307 
Deferred income taxes       2,128 
Changes in operating assets and liabilities:          
Accounts receivable, net   (14,998)   (320)
Inventory   (14,295)   672 
Prepaid expenses and other current assets   (874)   (492)
Other assets   659    (3)
Accounts payable   1,998    652 
Current tax liabilities   (654)   (2,684)
Accrued liabilities   6,328    (7,005)
Other current liabilities   191    1,103 
Long-term liabilities   (1,029)   (30)
Net cash used in operating activities   (58,382)   (65,401)
Cash flows from investing activities          
Additions to property, plant and equipment   (12,087)   (6,056)
Additions to capitalized software   (199)   (338)
Net cash used in investing activities   (12,286)   (6,394)
Cash flows from financing activities          
Proceeds from exercise of stock options   773    1 
Payments on finance leases   (179)   (72)
Payments on landlord financing obligation   (138)   (137)
Net cash provided by (used in) financing activities   456    (208)
Effect of exchange rate changes on cash   384    11 
Net increase (decrease) in cash and cash equivalents   (69,828)   (71,992)
Cash and cash equivalents at beginning of period   591,497    559,227 
Cash and cash equivalents at end of period  $521,669   $487,235 

 

 

 

Exhibit 99.2

 

  

 

GW Pharmaceuticals Reports Positive Phase 3 Pivotal Trial Results for EPIDIOLEX® (cannabidiol) Oral Solution in Patients with Seizures Associated With Tuberous Sclerosis Complex

 

- Achieved primary efficacy measure with both EPIDIOLEX doses as compared to placebo -

 

- Represents the fifth consecutive positive Phase 3 pivotal trial for EPIDIOLEX -

 

- Expect to file sNDA in Q4 2019 -

 

 

Carlsbad, CA, May 6, 2019: GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences Inc. (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced positive top-line results of a randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX® (cannabidiol or CBD) CV in the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare and severe form of childhood-onset epilepsy. In this trial, EPIDIOLEX met its primary endpoint, which was the reduction in seizure frequency compared to baseline of the Epidiolex 25 mg/kg/day dose group vs placebo (p=0.0009). Results for both the 25 and 50 mg/kg/day dose groups were similar, with seizure reductions of 48.6% and 47.5% from baseline respectively, vs 26.5% for placebo (50 mg/kg/day vs placebo, p=0.0018). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed is consistent with findings from previous studies, with no new safety risks identified.

 

“The positive outcome in this trial of EPIDIOLEX in patients with Tuberous Sclerosis Complex expands both our knowledge of this newly available medicine and its potential utility beyond the current indications,” stated Elizabeth Thiele, M.D., Ph.D., Director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, Professor of Neurology at Harvard Medical School and the lead investigator of the trial. “Data from previous controlled clinical trials of EPIDIOLEX have shown clinically meaningful seizure reductions and consistent safety and tolerability in children and adults with Lennox-Gastaut syndrome and Dravet syndrome. Based on the positive results of this trial in TSC patients, EPIDIOLEX, if approved for this additional indication, may become an important treatment option also in this disease state with significant unmet medical need.”

 

“The positive results from this trial represent the fifth positive Phase 3 trial for EPIDIOLEX and follows the recent U.S. launch of EPIDIOLEX for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. These new data show EPIDIOLEX reduced TSC-associated seizures, which include both focal and generalized seizures types, expanding the body of reliable science supporting the use of EPIDIOLEX,” stated Justin Gover, GW’s CEO. “With these data, we look forward to submitting an sNDA to the FDA in the fourth quarter with the goal of expanding the product label in 2020 to help the lives of patients suffering with TSC.”

 

 

 

 

“Some of the most challenging and frustrating aspects of tuberous sclerosis complex (TSC) are seizures that cannot be effectively controlled by existing medications,” explained Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance, “A new safe and effective treatment option such as Epidiolex is desperately needed. Further, we are grateful to GW, the researchers and the members of the TSC community who participated in this clinical trial. We are truly excited about the potential approval of Epidiolex to treat seizures in TSC as it brings much needed hope to those with TSC and their families who live daily with this difficult disorder.”

 

Trial Overview and Results

 

Patients aged 1-65 years with a confirmed diagnosis of treatment-resistant TSC were eligible to participate in this Phase 3, randomized double-blind placebo-controlled trial. The trial randomized 224 patients into three arms, where EPIDIOLEX 25 mg/kg/day (n=75), EPIDIOLEX 50 mg/kg/day (n=73) or placebo (n=76) was added to current anti-epileptic drug (AED) treatment. The average age of trial participants was 14 years (range 1-57). On average, patients were taking 3 AEDs, having previously tried and discontinued 4 other AEDs. The most common concomitant AEDs in this trial were valproic acid (45 percent), vigabatrin (33 percent), levetiracetam (29 percent), and clobazam (27 percent).

 

TSC associated seizures, as measured in the primary endpoint of this trial, differ from previous Epidiolex clinical trials in LGS and Dravet syndrome. These seizure types comprise focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures; and generalized seizures (tonic–clonic, tonic, clonic, or atonic) that are countable. The median baseline seizure frequency of the TSC associated seizure types was 57 per month.

 

The primary endpoint of the study was the change in seizure frequency over the 16-week treatment period (4-week titration followed by 12-week maintenance at the target dose) compared to baseline for the 25 mg/kg/day EPIDIOLEX arm vs placebo. The results for both the 25 and 50 mg/kg/day arms were similar, with seizure reductions of 48.6% and 47.5% from baseline, respectively, vs 26.5% for placebo (25mg/kg/day vs placebo, p=0.0009 and 50 mg/kg/day vs placebo, p=0.0018). All key secondary endpoints were supportive of the effects on the primary endpoint.

 

Previous clinical trials have evaluated the safety and efficacy of EPIDIOLEX at 10 mg/kg/day and 20 mg/kg/day, and U.S. prescribing information recommends a maintenance dose of 10 mg/kg/day. The TSC trial data represent the first pivotal safety data at the 25 mg/kg/day and 50 mg/kg/day dose levels.

 

 

 

 

The most common adverse events in patients receiving EPIDIOLEX in this study (≥10% and greater than placebo) include somnolence; decreased appetite; diarrhea; constipation; vomiting; transaminase elevations; pyrexia; seizure; cough; and infections. The incidence of diarrhea, vomiting, transaminase elevations, somnolence, and rash were higher in the 50 mg/kg/day group as compared to the 25 mg/kg/day group.

 

Regarding laboratory investigations, 12 percent of patients in the 25 mg/kg/day group experienced ALT elevations >3 ULN compared to 25 percent of patients in the 50 mg/kg/day group and none in patients on placebo. Consistent with the U.S. prescribing information, patients on concomitant valproic acid and on the higher dose experienced a higher rate of ALT elevations. There were no cases of Hy’s law observed and there were no deaths in this trial.

 

Dr. Volker Knappertz, GW’s Chief Medical Officer, said, “We are delighted to report this positive trial in patients with TSC. Both doses studied in this trial have been shown to be equally effective. There is a lower incidence of known adverse events and laboratory changes in the 25 mg/kg/day group compared with 50 mg/kg/day. As a result, we expect to focus our label expansion discussions with the FDA on the lower dose, which is close to the dose range already included in the U.S. prescribing information.”

 

This trial was conducted at more than 40 clinical sites in more than 6 countries. Detailed findings from this clinical trial will be reported at a future medical conference and subsequently published in a medical journal.

 

The EPIDIOLEX clinical development program now includes five randomized, controlled Phase 3 clinical trials (N=1,454) in LGS, Dravet syndrome and TSC. The previously completed Phase 3 studies have been published in The New England Journal of Medicine1,2, and the Lancet3. EPIDIOLEX represents the only development program of a plant-derived cannabinoid medication approved by the FDA.

 

1,2: Devinsky O, Patel AD, Cross HJ, et al. Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome. N Engl J Med. 2018 May; 378:1888-1897. doi: 10.1056/NEJMoa1714631; Devinsky et al. Trial of cannabidiol for drug resistant seizures in the Dravet syndrome.  N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

3: Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. 2018 March; 391(10125):1085-1096. doi: 10.1016/S0140-6736

 

About Tuberous Sclerosis Complex (TSC)

 

Tuberous sclerosis complex (TSC) is a rare genetic condition that causes tumors to grow in many different organs of the body. Almost all of these tumors are benign and grow most often in the brain, skin, heart, eyes, kidneys and lungs and can cause a variety of health problems. The symptoms of TSC usually appear before a child is 6 months old. The severity of the condition can vary widely — in some children the disease is very mild, while other children may have life-threatening complications. At least two children born each day will have tuberous sclerosis complex. The disorder affects as many as 40,000 to 80,000 individuals in the United States and about 1 to 2 million individuals worldwide, with an estimated prevalence of one in 6,000 newborns. Epilepsy is present in greater than 90 percent of patients with TSC and may progress to become intractable to medication. More than 60 percent of individuals with TSC and epilepsy do not achieve seizure control with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation, compared to 30-40 percent of individuals with epilepsy who do not have TSC who remain drug resistant. TSC is a leading cause of genetic epilepsy, often occurring in the first year of life as either focal seizures or infantile spasms. Untreated early-onset seizures are associated with an increased risk of autism and intellectual disability.

 

 

 

 

About EPIDIOLEX® (cannabidiol) oral solution

 

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. GW has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Epidyolex (European brand name) with an expected opinion date in the second quarter of 2019. 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.

 

Important Safety Information

 

CONTRAINDICATION: HYPERSENSITIVITY

 

EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.

 

WARNINGS & PRECAUTIONS

 

Hepatocellular Injury:

 

EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Transaminase and bilirubin levels should be obtained prior to starting treatment, at one, three, and six months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury.

 

Somnolence and Sedation:

 

EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.

 

Suicidal Behavior and Ideation:

 

Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness.

 

 

 

 

Withdrawal of Antiepileptic Drugs:

 

As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

 

Adverse Reactions:

 

The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed.

 

Pregnancy:

 

EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

 

Drug Interactions:

 

Moderate or strong inhibitors or inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam) or others. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary.

 

Drug Abuse:

 

EPIDIOLEX is a Schedule V controlled substance and has a low potential for abuse.

 

Indications:

 

EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.

 

Please refer to the EPIDIOLEX full Prescribing Information for additional important information.

 

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, along with its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA approval for EPIDIOLEX (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older and which is now available by prescription in the U.S. The Company has submitted a regulatory application in Europe for the adjunctive treatment of seizures associated with LGS and Dravet syndrome. The company continues to evaluate EPIDIOLEX in additional rare epilepsy conditions including Tuberous Sclerosis Complex (TSC) andRett 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 planning a U.S. Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. 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) 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 10-KT filed on February 26, 2018. Existing and prospective investors are cautioned not to place undue reliance on 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