• Skip to primary navigation
  • Skip to content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Business Directory
    • Buyers | Licensees
    • Sellers | Ancillary Businesses
    • Submit Product & Service Press Release
  • CBE Exchange
  • CBE Jobs Exchange
  • Events
  • Featured Videos
  • Product & Service Press Releases
  • Sponsored Polls
  • Webinars
    • Upcoming Webinars
    • Archived Webinars
  • Whitepapers

Cannabis Business Executive - Cannabis and Marijuana industry news

Recreational, Medical, Marijuana, Cannabis, And Hemp News for Cannabis Businesses

  • Follow on Facebook
  • Follow on Twitter
  • Follow on Google+
  • Follow on LinkedIn
  • Subscribe to our RSS feed
Newsletter 2
  • Home
  • Policy & Legal
    • Hemp Business Executive
    • International
      • Canada
      • Mexico
      • Israel
    • US A to F
      • Alabama
      • Alaska
      • Arizona
      • Arkansas
      • California
      • Colorado
      • Connecticut
      • Delaware
      • District of Columbia
      • Florida
    • US G to M
      • Georgia
      • Hawaii
      • Illinois
      • Indiana
      • Idaho
      • Iowa
      • Kansas
      • Kentucky
      • Louisiana
      • Maine
      • Maryland
      • Massachusetts
    • US M to N
      • Michigan
      • Minnesota
      • Mississippi
      • Missouri
      • Montana
      • Nebraska
      • Nevada
      • New Hampshire
      • New Jersey
      • New Mexico
      • New York
      • North Carolina
      • North Dakota
    • US O to V
      • Ohio
      • Oklahoma
      • Oregon
      • Pennsylvania
      • Rhode Island
      • South Carolina
      • South Dakota
      • Tennessee
      • Texas
      • Utah
      • Vermont
    • US V to W
      • Virginia
      • Washington
      • Wisconsin
      • Wyoming
      • Guam
      • Puerto Rico
  • Industry News
    • Advertising, Marketing, PR & Research
    • Banking, Finance & Real Estate
    • Compliance and Regulations
    • Corporate Social Responsibility
    • Retailers
    • Hemp Business Executive
    • HR and Staffing
    • North Of The Border
    • Industry People/On the Move
    • Packaging and Supplies
    • Press Releases
    • Processors
    • Producers
    • Security Solutions
    • Science and Technology
    • South Of The Border
  • CBE Lists
    • Ancillary Businesses
      • 2019 CBE Ancillary Business Survey CLICK HERE
      • 2018 CBE 155 A/B
      • 2017 CBE 150 A/B
      • 2016 CBE 100 A/B
    • Producers, Processors, Retailers
      • 2017 CBE 200 PPRs
      • 2015 CBE 100 PPRs
    • Industry Women
      • Glass Ceiling Wreckers: 2019 CBE Power Women of Cannabis
      • 2017 CBE 75 Most Important Women
      • 2016 CBE Top 50 Women
      • 2014 CBE Most Influential Women
    • Most Important Companies
      • 2016 CBE 10 Most Important Companies
      • 2014 CBE 10 Most Important Companies
    • Political 100
      • 2017 CBE Political 100
      • 2016 CBE 100 Political
      • 2014 CBE Political 50
    • 2014 CBE 100 Most Important People
    • CBE RFP Hotlists
      • 2014 CBE Lab Testing Services HotList
      • 2016 BHO Extraction Equipment
      • 2016 CBE Supercritical CO2 Extraction Equipment
      • 2016 CBE Security Solutions
      • 2016 Edibles & Infused Products
  • Company Stories
    • Up and Comers
  • Hemp Business Executive
    • Hemp Policy & Legal
    • Hemp Industry News
    • Hemp State Regulatory Agencies
  • Newsletters
    • CBE Week
    • CBE Human Capital Management
    • CBE Technology & Solutions
    • CBE Policy and Legal Update
    • CBE Product and Service Announcements
  • Op-Ed
    • Cartoons
    • The Buck Stops Here
    • Opinions
    • Comments
  • Associations
  • State Regulatory Agencies
    • Marijuana
    • Hemp
  • Contact
  • AB Survey
  • About Us
  • Account
  • Accounting Services
  • Advertise
  • Advertising, PR & Marketing
  • All Cannabis News
  • Ancillary Business Survey 2018
  • Ancillary Business Survey 2019
  • Archived Webinars
  • Associations & Organizations
  • Banking & Payment Processing
  • Better Start for the Glass Ceiling in this Industry, CBE’s Most Influential Women
  • Book Reviews
  • Business Directory
  • Business Directory Introduction
  • Business Directory Listing
  • Business Directory Manage
  • Business Directory Registration Info
  • Business Directory Welcome
  • Call for speakers
  • Cannabis Investments
  • Cart
  • CBE Exchange
  • CBE HotLists
    • CBE Lab Testing Services HotList 2014
  • CBE Lists
  • CBE Political 50
  • CBE Press LLC Privacy Statement
  • CBE Press News
  • Checkout
  • Consulting Services
  • Consumption Gear
  • Contact
  • Contribute
  • Contributors
  • Create Your Product & Service Press Release
  • Creative Submission
  • Cultivation Products & Services
  • Current Poll
  • Edible & Infused Products
  • Editor’s Page
  • Email Whitelisting Instructions
  • Event Listing Questionaire
  • Featured Videos
  • Funding Options
  • Hemp State Regulatory List
  • Home
  • Human Capital Management Newsletters
  • Industry Jobs
  • Join the CBE Business Directory
  • Join the Directory
  • Lab Testing Regulations
  • Lab Testing Services
  • Login
  • Logout
  • Marijuana State Regulatory Contacts
  • Marijuana Tax Facts
  • Media Kit
  • Medical Marijuana Qualifying Conditions
  • Members
  • MJ Media Kit
  • Most Popular Stories
  • Most Read Stories
  • New Product & Service Listings Welcome
  • News Releases
  • Newsletters
    • Ask CBE
    • CBE Human Capital Management
    • CBE Policy and Legal Update
    • CBE Product and Service Announcements
    • CBE Technology & Solutions
    • CBE Week
  • On the Move
  • Organizations & Associations
  • Packaging & Supplies
  • Password Reset
  • Policy & Legal
  • PPR Survey
  • Product Releases
  • Profile Update
  • Register
  • Security Solutions
  • Software & Technology
  • Sponsored Polls
  • State Cannabis Product Packaging Requirements
  • Terms of Service
  • Thank You
  • The Most Influential People in the Cannabis Industry, The Cannabis Business Executive 100
  • Training & Educational Services
  • Upcoming Webinars
  • User
  • Whitepapers
  • WV Senate passes medical marijuana bill to House
  • Categories
  • Locations
  • My Bookings
You are here: Home / Company Stories / GW Pharmaceutical: A Cut Above the Rest
GW Pharmaceuticals GWP

GW Pharmaceutical: A Cut Above the Rest

September 28, 2016 by Rob Meagher Leave a Comment

I think Forbes said it best in Debra Borchardt’s recent article, “GW Pharmaceutical Gets Closer To Forcing FDA On Cannabis,” with an  announcement a couple of weeks ago that its Clinical Phase 3 trial results for Epidolex were positive in paving the way for FDA approval and tipping over the de-scheduling apple cart.

Whether it materializes in an immediate change or not remains to be seen. The prohibitionists surely have more dirty tricks up their sleeves and will continue to rear their ugly heads every step of the way until the FDA formally takes over the regulatory oversight of medical marijuana for over- and under-the-counter cannabis products in the United States.

Since we first included GW Pharmaceuticals (GWP) on the original CBE 10 Most Important Companies list (#5), we have spoken to many industry players about the inevitable final play for medical marijuana in the U.S. Realistically, we all know that the push for legalizing and regulating “medical marijuana” on a state level has been successful in moving the public opinion meter among Democrats and Republican law makers, and has played well in the battle to end Federal prohibition. At the end of the day, despite all of the anecdotal evidence, “medical marijuana” is not medicine according to the Food and Drug Administration (FDA) until it completes a long, arduous, and expensive process to receive approval as a medicine for use by humans. This process can take up to 10 years per drug application.

When you look at what the cannabis pharmaceutical business that GWP has been building since its inception in 1998, you have to consider the risk and magnitude of the investment that its investors and shareholders made without a guarantee of return. The process includes many steps for New Chemical Entity (NCE) development that includes several steps outlined by Wikipedia below, including:

Preclinical Development

In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.

They further examine the product for suitability to package as capsules, tablets, aerosols, intramuscular injectables, subcutaneous injectables, or intravenous formulations.

Only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug.

Clinical Phase

Clinical trials involve three or four steps:[1]

  • Phase I trials, usually in healthy volunteers, determine safety and dosing.
  • Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of patients having the disease targeted by the NCE.
  • Phase III trials are large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients with the targeted disease. If safety and efficacy are adequately proved, clinical testing may stop at this step and the NCE advances to the new drug application (NDA) stage.
  • Phase IV trials are post-approval trials that are sometimes a condition attached by the FDA, also called post-market surveillance studies.

Most NCEs fail during drug development, either because they have unacceptable toxicity or because they simply do not have the intended effect on the targeted disease as shown in clinical trials.

Cost

One study assessed both capitalized and out-of-pocket costs as about US$1.8 billion and $870 million, respectively

Success Rates

A study conducted by the Tufts Center for the Study of Drug Development covering the 1980’s and 1990’s found that only 21.5 percent of drugs that started Phase I trials were eventually approved for marketing.[9] Between 2006 to 2015, the success rate was 9.6 percent.

With all of this in mind, GWP which is based in Salisbury, United Kingdom, is the first company in the world to develop a prescription drug that is the first natural cannabis plant derivative to gain market approval in any country. GWP’s first product, Sativex®, is now approved in 28 countries for the treatment of multiple sclerosis spasticity.

According to GWP’s 2015 annual report, they describe several accomplishments after investing nearly a billion dollars since inception.

  • GWP employs more than 350 staff, including over 300 in the UK, and in its emerging U.S. commercial and development operation to complement the UK scientific and manufacturing base expansion.
  • GWP has research collaborations with 36 universities around the world.
  • The UK commercial manufacturing facility has been inspected and approved by multiple regulatory authorities.
  • Forty-four (44) Phase 2 and Phase 3 clinical trials were conducted and included over 4,379 patients.
  • They conducted post-market safety studies involving over 1,000 patients.
  • GWP’s research has led to over 80 publications in peer review journals.
  • Evaluations of 14 distinct cannabinoids in pre-clinical research were completed.
  • Over 45,000 patient-years of human safety data have been generated on cannabinoid medicines.
  • Cannabinoids have been exported to 37 countries for research purposes.

With the successful completion of the Phase 3 Trial for Epidolex®, a new cannabidiol-based drug used to treat children with Dravet syndrome and Lennox-Gastaut syndrome (“LGS”) a rare form of childhood epilepsy, GWP’s next move for Epidolex is to gain approval from the FDA. It expects to submit a new drug application with the FDA in the first half of 2017. If approved, it would be a first—a plant-derived cannabinoid drug in the U.S. that hopefully forces the de-scheduling and removal of cannabis from the list of Control Substances.

There are several more new drugs in the pipeline for GWP in the U.S., below are some of the studies in progress.

  • Phase 2a CBD schizophrenia study data shows positive proof-of-concept with a reassuring safety profile.
  • Phase 2 CBDV epilepsy study in adults under way with data expected H2 2016.
  • Neonatal Hypoxic-Ischemic Encephalopathy (“NHIE”) IV CBD Phase 1 clinical program expectedto commence in H1 2016.
  • Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016.
  • Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (“GBM”) fully enrolled with data expected in mid-2016.
  • Phase 2 study in type-2 diabetes fully enrolled with data expected mid-2016.
  • Phase 2 study of Sativex® in spasticity due to cerebral palsy ongoing with data expected mid 2016.

With so much at stake, CBE would be remiss in not following GWP and CEO Justin Gover, who recently relocated to the West Coast. One thing is for sure: GWP is in the middle of the bulls-eye for cannabis investors.

 

 

 

 

 

 

Filed Under: Company Stories, Science and Technology Tagged With: Dravet syndrome, Epidolex, Lennox-Gastaut syndrome (“LGS”), Sativex, U.S. Food and Drug Administration

About Rob Meagher

Rob Meagher, CBE’s Founder, President and Editor-in-Chief is a 30 year veteran of the media world. His career has spanned from stints representing the Washington Post, USA Weekend, Reader’s Digest, Financial World & Corporate Finance to the technology world where he worked at International Data Group and Ziff Davis where he was part of the launch team for The Web Magazine, Yahoo Internet Life, Smart Business and Expedia Travels before starting his own marketing and Publisher’s Representative Firm. He also ran all print and online media sales and marketing for the Society for Human Resource Management before partnering with Forbes and then Fortune to create Special Sections covering a variety of topics. Rob, who started CBE Press in 2014, can be contacted at [email protected]

Primary Sidebar

Ad: Sidebar 1

Featured Video

Associations & Organizations

clearing div

Ad: Sidebar 2

Business Directory

Ad: Skyscraper 1

CBE Jobs Exchange


Featured Jobs
Go
Post a Job
More jobs
Powered by CBEJobsExchange.com

RSS Recent Jobs

  • Hearing Officers (Apply by Feb. 5th) - The Broward County Attorney's Office - Fort Lauderdale, FL
  • Field Service Engineer Agilent GC/MS - VRS Recruitment - , MA
  • Business Development Officer - Specialty Ag - Bank Michigan - Ann Arbor, MI

Product & Service Press Releases

Ad: Sidebar 3

CBE Events

Ad: Sidebar 4

State Regulatory Agencies

Ad: Skyscraper 2

Webinars

Ad: Sidebar 5

Associations & Organizations

Ad: Sidebar 6

Featured Video

Ad: Skyscraper 3

Business Directory

Ad: Sidebar 7

CBE Jobs Exchange

Ad: Sidebar 8

CBE Events

Ad: Skyscraper 4

Industry Blogs



Footer

  • Home
  • About Us
  • Advertise
  • Contact
  • CBE Press LLC Privacy Statement
  • Contribute
  • Contributors
  • Newsletters
  • Terms of Service
  • Contributor Login
  • Follow on Facebook
  • Follow on Twitter
  • Follow on Google+
  • Follow on LinkedIn
  • Subscribe to our RSS feed
Newsletter 2

© Copyright 2020 CBE PRESS LLC. - All Rights Reserved. Cannabis Business Executive Is A Trademark Of CBE PRESS LLC. · All Rights Reserved · And Our Sitemap · All Logos & Trademarks Belong To Their Respective Owners·