GW Pharmaceuticals PLC- ADR

BS

Phar..

overview

Overview

GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.

As a biopharmaceutical company, it engages in discovering, developing, and commercialising cannabinoid prescription medicines using botanical extracts derived from the Cannabis plant

Their lead product candidate is Epidiolex® (cannabidiol) for certain rare and severe early-onset, drug-resistant epilepsy syndromes.

GW successfully developed the world’s first prescription medicine derived from the cannabis plant, Sativex®, now approved in numerous countries outside of the United States for the treatment of spasticity due to Multiple Sclerosis.

The company has a deep pipeline of additional clinical stage cannabinoid product candidates for both orphan and non-orphan indications with a particular focus on neurological conditions.

GW Pharmaceuticals was founded in 1998 and is listed on the NASDAQ Global Market (GWPH). The company has operations in both the US and the UK.

The Strategy

GW’s lead product candidate is Epidiolex®, is a liquid formulation of pure cannabidiol (CBD) for severe early-onset, drug-resistant epilepsy syndromes. Epidiolex is the result of extensive pre-clinical research of CBD in epilepsy which dates back to 2007 and which has reported significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models Through the combination of rapid cost-effective product development that addresses these unmet needs, GW seeks to maximise the value of its product development opportunities and shareholder returns.

GW’s strategy is to maintain a world leading position in the field of cannabinoid science and in the research, development and commercialisation of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. In seeking to implement this strategy, GW has developed an extensive international network of the most prominent scientists in the cannabinoid field and has also assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical product formulation.

GW manufactures its prescription pharmaceutical products to meet the stringent cGMP requirements of the U.S. FDA and other global regulatory authorities. GW establishes controls over all facets of product development, manufacturing and commercial distribution.

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Differentiators

  • OrphanDesignation
    • 7 years in the US plus expected 6-month paediatric extension
    • 10 years in the EU plus expected 2 years paediatric extension
  • IntellectualProperty
    • Pursuing a patent strategy designed to have patents issued to protect lead drug candidate and other pipeline candidates beyond Orphan Designation
    • Current portfolio includes multiple distinct patent families in the treatment of epilepsy and formulations
      • To date, 3 patents granted by the USPTO
      • Currently, no patents issued or listed in the Orange Book with respect to Epidiolex
  • Additional patent applications expected as new data is generated
  • Life-cycle management through new indications, formulation improvements, combinations and additional commercial geographies
    • Proposed new formulations include liquid, solid dose, intravenous

Patent Portfolio

Products

Epidiolex

  • Epidiolex is GW’s lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD.
  • GW’s Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).
  • GW’s Epidiolex development includes two distinct programs:
    • FDA-authorised clinical trials program
    • FDA-authorised, independent Physician-led program or Expanded Access

Commercialisation Status

  • Global commercialisation rights to Epidiolex fully-owned by GW Pharmaceuticals Group companies
  • In the US we will use our subsidiary, Greenwich Biosciences Inc., to commercialise our products
  • US Launch Preparations
    • Full commercial leadership team in place
    • Finalising build-out of experienced team of medical affairs professionals, marketing and market access/payor experts, many of whom have strong epilepsy knowledge and experience
    • Active discussions in U.S. with a wide variety of payers and insurance programs
  • “High-touch” patient, payer and physician communication, education and distribution model
  • EU commercial footprint now in place in five major European markets

The Epidiolex Journey

Sativex

  • Oromucosal spray of a formulated extract of cannabis that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:1 ratio
  • Approved in >25 countries outside the United States for the treatment of spasticity due to Multiple Sclerosis (MS). Product is sold via marketing partners
  • New placebo-controlled trial data presented at ECTRIMS 2017 – positive primary and secondary endpoints
  • GW reacquired full rights to develop and commercialise Sativex in U.S. (December 2017). Previous license agreement with Otsuka terminated
  • Represents a new wholly-owned late-stage US asset
  • The company expect to evaluate the optimal route to achieve a NDA and believe that this may require the conduct of an additional single pivotal trial

Commercial Manufacturing

growth

Cannabinoid Platform

  • Cannabis plant is a unique source of >100 cannabinoid molecules capable of targeting diseases across therapeutic areas and mechanisms
  • TRP channels, adenosine re-uptake, serotonin receptors, endocannabinoid system
  • GW has a deep pipeline of additional cannabinoid product candidates
  • Focus on orphan paediatric neurologic conditions within epilepsy, autism, NHIE, schizophrenia
  • Existing physician relationships through Epidiolex program
  • U.S. development and commercialisation rights to Sativex reacquired from Otsuka, plans underway to commence U.S. pivotal trial in MS spasticity

Upcoming Milestones

management team

Dr. Geoffrey Guy - Chairman and Founder

Dr Geoffrey Guy is the founder of the Company and has served as Chairman since 1998.

Dr Guy is the creator of Sativex and Epidiolex and continues to lead innovation and new product discovery.

Dr Guy has been actively involved in scientific innovation, medical research and global drug development for his entire career.

Prior to his role at GW, Dr Guy served as Chairman and Chief Executive of Ethical Holdings plc, a NASDAQ-quoted drug delivery Company.

Justin Gover - CEO and Executive Director

Justin Gover has served as Chief Executive Officer of GW Pharmaceuticals since January 1999, shortly afer the Company was founded. He has 21 years’ experience in the pharmaceutical industry.

As Chief Executive Officer, Mr. Gover has been the lead executive responsible for the running of the company’s operations, leading equity financings and business development activities.

He raised initial rounds of private capital, following which led the company’s initial public offering on the AIM stock exchange in London in 2001, and more recently led GW’s initial public offering on Nasdaq in 2013.

Dr Volker Knappertz - Chief Medical Officer

Dr. Volker Knappertz has served as Chief Medical Officer since May 2017. Dr. Knappertz has over 25 years of clinical trial experience and 17 years of pharmaceutical drug development experience, holding leadership positions with responsibilities for managing international clinical trial and medical affairs programs.

Most recently, as the Vice President of clinical development for multiple sclerosis, oncology and biosimilar products at Teva Pharmaceuticals, Dr. Knappertz oversaw multiple regulatory submissions and approvals in the U.S., Canada, Europe and Japan.

Chris Tovey - Chief Operating Officer

Chris Tovey has served as Chief Operating Officer since October 2012. Mr. Tovey has over 25 years experience in the pharmaceutical industry.

Prior to joining the Company, Mr. Tovey was at UCB Pharmaceuticals from 2006 to 2012. Most recently, Mr. Tovey was the Vice President of Global Marketing Operations where he was responsible for worldwide marketing activities on a portfolio of UCB products generating over €2.0 billion in annual sales.

Mr. Tovey previously spent 18 years at GlaxoSmithKline plc in senior commercial roles in both the European and U.K. organisations.