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 April, 2017
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.
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):
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):
Other Events
On April 18, 2017, GW Pharmaceuticals plc
(the “Company”) announced that the American Academy of Neurology (AAN) issued a press release announcing positive results
from a second Phase 3 study (GWPCARE3) of Epidiolex® (cannabidiol or CBD) in children and adults with Lennox-Gastaut syndrome
(LGS). The data will be presented at the upcoming meeting of the AAN in Boston, Massachusetts. A copy of the Company’s press
release is attached as Exhibit 99.1 hereto and is incorporated by reference herein. A copy of the Company’s poster for the
AAN meeting is attached as Exhibit 99.2 hereto and is incorporated by reference herein. The information contained in Exhibit 99.1
and Exhibit 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 Company Press
Release on American Academy of Neurology (AAN) Announcement
99.2 Company Poster
for the AAN Meeting
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.
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GW
Pharmaceuticals plc |
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By: |
/s/
Adam George |
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Name: |
Adam
George
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Title: |
Company
Secretary
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Date:
April 25, 2017 |
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Exhibit 99.1
GW Pharmaceuticals and its U.S.
Subsidiary Greenwich Biosciences Highlight New
Epidiolexâ
(cannabidiol) Data Released by the American Academy of Neurology
More Detailed Poster Presentation Scheduled
for April 25, 2017 at AAN Annual Meeting
London,
UK, 18 April 2017: 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, noted that the American Academy of Neurology (AAN)
issued a press release today announcing positive results from a second Phase 3 study (GWPCARE3) of Epidiolex® (cannabidiol
or CBD) in children and adults with Lennox-Gastaut syndrome (LGS). The data will be presented at the upcoming meeting of the American
Academy of Neurology (AAN) in Boston, MA.
In the GWPCARE3 study, adding Epidiolex
to patients’ current treatment significantly reduced the frequency of drop seizures at both the 10 mg/kg/day and 20mg/kg/day
doses. During the 14-week treatment period, patients taking both doses of Epidiolex saw a significantly greater median reduction
in monthly drop seizures (37 percent and 42 percent, respectively) compared with a 17 percent reduction for placebo (p=0.0016 and
p=0.0047, respectively). New data from key secondary endpoints also showed that a significant number of patients receiving Epidiolex
10 mg/kg/day (36 percent) and Epidiolex 20 mg/kg/day (40 percent) experienced a 50 percent or greater reduction in monthly drop
seizures compared with those taking placebo (15 percent, p=0.0030 and p=0.0006, respectively). In addition, significantly more
patients/caregivers reported an improvement in overall condition with Epidiolex 10mg/kg/day (66 percent) and Epidiolex 20mg/kg/day
(57 percent) compared to 44 percent for placebo (p<0.05 for both comparisons) based on the Subject/Caregiver Global Impression
of Change (S/CGIC) questionnaire.
"Lennox-Gastaut syndrome is one of
the most challenging types of epilepsy to treat. Results from this large, placebo-controlled study demonstrate that Epidiolex
provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile,"
said study investigator Anup Patel, M.D., of Nationwide Children’s Hospital and The Ohio State University College of Medicine.
“I believe Epidiolex has the potential to change the treatment of LGS and I am excited at the future prospect of prescribing
an appropriately standardized and tested pharmaceutical formulation of cannabidiol."
Epidiolex was generally well tolerated
in the trial. The pattern of adverse events was consistent with that reported in previous Phase 3 studies. One patient on
10mg/kg Epidiolex discontinued treatment due to an adverse event compared with six patients on 20mg/kg and one patient on placebo. Adverse
events (AEs) occurred in 94 percent of patients taking Epidiolex 20mg/kg, 84 percent of patients taking Epidiolex 10mg/kg, and
72 percent of placebo patients. Most were mild or moderate; the two most common (greater than 10 percent) were sleepiness and decreased
appetite.
"We are pleased that AAN has chosen
to highlight data from our Phase 3 epilepsy program at this prestigious meeting of the broader neurology community. New results
from our largest and most recently completed LGS study offer a first look at the significant efficacy of two different doses of
Epidiolex added to existing anti-epileptic drug treatment over placebo,” said Justin Gover, GW's Chief Executive Officer.
“This latest data from our Phase 3 program reinforces the potential of Epidiolex to become an important new medicine for
patients who suffer from LGS and our planned NDA submission remains on track for the middle of this year.”
Additional data will be presented in a
poster at the AAN Annual Meeting on April 25, 2017 at 6.06pm EDT, at which time GW will make an additional disclosure.
The
full text of the AAN announcement is available at: https://www.aan.com/pressroom
About Lennox-Gastaut
Syndrome
The peak onset
of LGS typically occurs between ages of three to five 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 drop, convulsive and non-convulsive
seizures, which frequently lead to falls and injuries. Drug resistance is one of the main features of LGS. Most children with LGS
experience intellectual disability 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 Epidiolex
Epidiolex, GW's lead cannabinoid product
candidate, is a liquid formulation of plant-derived cannabidiol (CBD), which is in development for the treatment of a number of
rare childhood-onset 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 efficacy in reducing 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 U.S. Food and Drug Administration (FDA) for Epidiolex
for the treatment of Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS),
each of which are severe infantile-onset, drug-resistant epilepsy syndromes. Additionally, GW has received Fast Track Designation
from the FDA for the treatment of Dravet syndrome and Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex
for the treatment of Dravet syndrome and LGS. 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-onset 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® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis
in 31 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 operates through its subsidiary
Greenwich Biosciences, Inc. 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® 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 of uncertainties related to the regulatory process, and the
acceptance of Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties
associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including
the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the
information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Enquiries:
GW Pharmaceuticals plc |
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Stephen Schultz, VP Investor Relations |
401 500 6570 |
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U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
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Christy Curran
Mike Beyer |
615 414 8668
312 961 2502 |
Exhibit 99.2
This regulatory filing also includes additional resources:
v464842_ex99-2.pdf