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Potential of First-In-Class Epidiolex for Epilepsy and Its Significance in the Advent of Medical Marijuana

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Potential of First-In-Class Epidiolex for Epilepsy and Its Significance in the Advent of Medical Marijuana Datamonitor Healthcare Pharma intelligence | Potential of First-in-Class Epidiolex for Epilepsy and its Significance in the Advent of Medical Marijuana Request a demonstration of Datamonitor Healthcare Stephanie Yip Analyst II Introduction 25 June 2018 marked the US Food and Drug marijuana, which is the primary cannabinoid Administration’s (FDA’s) approval of GW responsible for its euphoric effects and has little Pharmaceuticals’ cannabidiol (CBD) Epidiolex to treat affinity to the cannabinoid CB1 receptor that is rare, severe pediatric epilepsies, namely Lennox- associated with psychoactivity3. Epidiolex is thought Gastaut syndrome and Dravet syndrome1,2. This to exert its anticonvulsant effects via the activation landmark approval holds prominence for multiple of several pathways, such as modulation of facets of the pharmaceutical market. Epidiolex has intracellular calcium, neuronal inhibition, and anti- crucially become the first FDA-approved drug for inflammatory effects, although this remains to be Dravet syndrome, a first-in-class drug in the epilepsy confirmed4. market, as well as the first cannabis-derived drug approved by the FDA. This event signifies a milestone Utilizing Informa Pharma Intelligence’s data, moment not only for this exceptional medication, forecasts, and analysis from Biomedtracker, but for the wider pharmaceutical market. Datamonitor Healthcare, Pharmaprojects, and news from Scrip, this report elucidates the role of Epidiolex Epidiolex is a liquid pharmaceutical formulation within the epilepsy market and further explores its of pure plant-derived CBD, a type of cannabinoid significance within the broader context of global present in marijuana. The drug does not contain cannabinoid development. the tetrahydrocannabinol (THC) component of 1. FDA (2018) FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm [Accessed 5 July 2018]. 2. GW Pharmaceuticals (2018) GW Pharmaceuticals plc and its U.S. Subsidiary Greenwich Biosciences Announce FDA Approval of EPIDIOLEX® (cannabidiol) oral solution – the First Plant-derived Cannabinoid Prescription Medicine. Available from: https://www.gwpharm.com/about-us/news/gw- pharmaceuticals-plc-and-its-us-subsidiary-greenwich-biosciences-announce-fda [Accessed 5 July 2018]. 3. Biomedtracker, July 2018. 4. GW Pharmaceuticals (2018) Mechanism of Action. Available from: https://www.gwpharm.com/products-pipeline/research-trials/mechanism-action [Accessed 5 July 2018]. 2 / August 2018 © Informa UK Ltd 2018 (Unauthorized photocopying prohibited.) Epidiolex’s impact in the epilepsy market as a first-in-class drug for underserved epilepsies Becoming the drug of choice for childhood only approved therapy being stiripentol in the EU, epilepsies will allow Epidiolex to fulfill Epidiolex is especially highly anticipated in the US. critical unmet need Despite its niche positioning, Epidiolex is GW Pharmaceuticals is positioning Epidiolex as the product of choice for the treatment of rare projected to generate strong sales childhood epilepsies. Not only has the drug made Despite Epidiolex’s niche positioning for rare a breakthrough as the first FDA-approved drug for pediatric epilepsies, Datamonitor Healthcare Dravet syndrome and become a welcome addition forecasts strong sales potential, with a peak of for Lennox-Gastaut syndrome patients, but it is $822m in 2025 (see Figure 1 and Table 1)7. Multiple also being studied for tuberous sclerosis complex. drivers fuel Epidiolex’s commercial potential, and its These syndromes are recognized to be treatment- unprecedented FDA approval for Dravet syndrome refractory with very few effective therapy options. will expand the market and considerably boost Hence, the company is targeting a spectrum uptake given the absence of clear competitors. of niche pediatric syndromes that are severely Its substantial sales can also be ascribed to US underserved. physicians’ familiarity with Epidiolex through its Expanded Access Program that involved patients In a primary research study of 258 neurologists with an array of intractable childhood-onset conducted by Datamonitor Healthcare in May epilepsies. Although Epidiolex will have to compete 2016 to gain insights into the epilepsy treatment with approved therapies (Banzel [rufinamide; Eisai], landscape, respondents highlighted the critical Lamictal [lamotrigine; GlaxoSmithKline], and Onfi unmet need for therapies targeting these complex [clobazam; Lundbeck]) in the Lennox-Gastaut pediatric epilepsies, which are associated with syndrome segment, its differentiated mechanism of poor prognosis5. In particular, Dravet syndrome action compared to traditional anticonvulsants and is a progressive and serious genetic disorder first-in-class advantage will nonetheless encourage characterized by a high risk of early mortality due prescriptions. Ultimately, Epidiolex is attractive to sudden unexplained death in epilepsy (SUDEP). due to its novelty and ability to fulfill unmet need Patients present with multiple seizure types, often in the epilepsy market. With its prize asset, GW including life-threatening status epilepticus (a Pharmaceuticals is targeting approximately 35,000 prolonged state of continuous seizure activity)6. Lennox-Gastaut syndrome patients and 8,000 Dravet syndrome is one of the most highly Dravet syndrome patients in the US8. pharmacoresistant forms of epilepsy, and with the 5. Datamonitor Healthcare’s Treatment: Epilepsy, May 2017. 6. National Organization for Rare Disorders (2018) Dravet syndrome. Available from: https://rarediseases.org/rare-diseases/dravet-syndrome-spectrum/ [Accessed 5 July 2018]. 7. Datamonitor Healthcare’s Forecast: Epilepsy, July 2017. 8. Scrip (2018) Gottlieb: Epidiolex Approval Covers One Specific Cannabidiol Medication, Not Marijuana. Available from: https://scrip.pharmaintelligence. informa.com/SC123312/Gottlieb-Epidiolex-Approval-Covers-One-Specific-Cannabidiol-Medication-Not-Marijuana [Accessed 5 July 2018]. © Informa UK Ltd 2018 (Unauthorized photocopying prohibited.) August 2018 / 3 Figure 1. Epidiolex sales for epilepsy across the US and five major EU markets, by country, 2016–25 800 600 400 Sales ($m) 200 0 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 US France Germany Italy Spain UK Sales 2016 - 2025: Max: 2025, $822m Sales Change 2016 - 2025: $822m Table 1. Epidiolex sales for epilepsy across the US and five major EU markets, by country ($m), 2016–25 Country 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 US - - 26 109 204 309 427 554 675 788 France - - - - 1 2 4 5 6 6 Germany - - - 1 2 3 3 4 5 5 Italy - - - - 1 2 4 5 6 7 Spain - - - - 1 2 3 4 5 6 UK - - - 1 3 5 6 8 9 10 Total - - 26 111 212 324 447 579 705 822 Note: totals may not sum due to rounding. Source: Datamonitor Healthcare’s Forecast: Epilepsy, July 2017 4 / August 2018 © Informa UK Ltd 2018 (Unauthorized photocopying prohibited.) Competitors, cost, and clinical concerns the Lennox-Gastaut syndrome niche7. Furthermore, are challenges that Epidiolex will face in as Epidiolex is intended to be taken twice daily as an adjunct in combination with anticonvulsants, total the epilepsy market treatment costs may exceed this. Epidiolex is also Although the anticipated availability of Epidiolex likely to encounter mounting payer pressure as the in fall 2018 is certainly momentous for the epilepsy market is currently widely genericized, and cannabinoid class and a major therapeutic this trend will only steepen with anticipated patent breakthrough for neglected rare epilepsies, the drug cliffs. However, Epidiolex’s novelty as a new drug will likely face certain challenges. Epidiolex’s first- class, and high demand given the unmet need and to-market advantage in Dravet syndrome may not a lack of viable treatment options, could potentially confer protection from competitors for long. Zogenix justify its cost. has produced impressive Phase III data for its pipeline candidate ZX008 (low-dose fenfluramine) From a clinical perspective, Epidiolex’s pivotal 9 in Dravet syndrome . ZX008 demonstrated a 63.9% trials have displayed mixed efficacy, tolerability, reduction in mean convulsive seizure frequency and safety attributes. Although its efficacy for over placebo, surpassing a 26% reduction shown Dravet syndrome is unparalleled, its efficacy for 10,11 by Epidiolex in a separate trial . ZX008 is in Phase Lennox-Gastaut syndrome seems moderate. While III trials for both Dravet syndrome and Lennox- comparing between different trial settings is difficult, Gastaut syndrome, making it a notable competitor Onfi demonstrated robust efficacy for Lennox- as its targeted segments of the epilepsy market Gastaut syndrome with a reduction in seizure overlap with those of Epidiolex. Therefore, it is likely rates that appears to supersede competitors. In that Epidiolex’s future opportunity may become controlled trials, the most common adverse events restricted by other effective treatment options as (≥10% incidence and greater than placebo) in they reach the market. Epidiolex patients included somnolence, decreased appetite, diarrhea, and transaminase elevations, Epidiolex will enter the epilepsy market at an annual among others. Epidiolex’s prescribing information cost four times higher than the average of other incorporates warnings pertaining to issues often branded oral anticonvulsants. During an investor associated with anti-epileptic drugs: somnolence call, GW
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