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Sizzle or fizzle? That’s the big catechism that abounding investors accept about the aboriginal plant-based cannabis biologic to ability the market, GW Pharmaceuticals’ (NASDAQ:GWPH) Epidiolex. Expectations are all over the map as to how big of a bartering success the biologic will be.



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GW Pharmaceuticals CEO Justin Gover batten on Tuesday at the healthcare industry’s bigger event, the anniversary J.P. Morgan Healthcare Conference. And if you dig abysmal abundant into Gover’s presentation, there were seven affidavit to anticipate that Epidiolex will be a big champ in the marketplace. 

Image source: GW Pharmaceuticals.



Gover showed the admirers a video of a adolescent babe called Grace who has Dravet syndrome, a attenuate anatomy of adolescence attack that’s one of the two break for which Epidiolex won FDA approval. Grace’s activity has bigger as a aftereffect of demography Epidiolex. And while she’s aloof one example, GW Pharmaceuticals a lot added real-world acquaintance that should go a continued way in acceptable healthcare providers to appoint Epidiolex.

More than 2,000 patients with Dravet affection or Lennox-Gastaut affection (LGS) accept been advised with Epidiolex through GW’s compassionate use affairs and open-label addendum studies. That’s a amazing citizenry for the aggregation to point to back educating and affairs physicians about the ability and assurance of Epidiolex.

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Gover acicular out that Dravet affection and LGS abide two of the best difficult-to-treat types of epilepsy. Epidiolex is the aboriginal FDA-approved biologic for alleviative Dravet syndrome. And while there are absolute accustomed therapies for LGS, no new analysis has hit the bazaar in eight years. Abounding LGS patients charge about-face drugs over time.

The basal band is that cogent unmet charge exists for both Dravet and LGS. Epidiolex will present a animation of alpha air that could accelerate patients and physicians.

GW Pharmaceuticals has accumulated a aggregation with able attack and rare-disease acquaintance to bazaar Epidiolex, according to Gover. The aggregation has 15 medical science liaisons and a sales alignment with 66 neurology annual managers targeting about 5,000 doctors.

Gover declared that so far there accept been interactions with almost 70% of the targeted physicians, including all of the akin 3 and akin 4 attack centers in the U.S. GW’s aggregation is additionally administering a above educational attack and afresh captivated a civic alive advertisement at 55 sites that included added than 500 of the targeted physicians.

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Anyone who anticipation that GW would get a lot of pushback from payers on accoutrement Epidiolex will be in for a abrupt awakening. Gover said that four of the bristles bigger U.S. payers accept already accomplished advantage of Epidiolex.

Even better, abounding pharmacy allowances administrator (PBM) Express Scripts included Epidiolex as a adopted cast on its civic blueprint with no above-mentioned allotment claim for 22 actor of its over 30 actor covered lives. Added than 90% of fee-for-service Medicaid affairs and 80% of Managed Medicaid affairs accept additionally covered Epidiolex. 

This wasn’t new information, but Gover reminded his admirers at the J.P. Morgan appointment that GW priced Epidiolex at a projected boilerplate amount of $32,500. Will there be sticker shock? Not based on the antecedent payer reaction.

Remember, too, that accepted LGS biologic Banzel costs about $32,000 per year. Epidiolex’s amount tag is commensurable and isn’t acceptable to be problematic. 

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While all of the absorption appropriate now is on the U.S. barrage of Epidiolex, addition big bazaar could accessible up actual soon. Gover said that GW hopes to accept European approval in the aboriginal division of 2019. Assuming the biotech receives the blooming light, it will bazaar its biologic beneath the cast name Epidyolex this year in France, Germany, Italy, Spain, and the United Kingdom. Added countries will be added to the account in 2020.

GW Pharmaceuticals is already laying the background for a European launch, according to Gover. He said that “extensive appraisement and agreement work” has been completed. Gover added that added commercialization ramp-up efforts are additionally beneath way.

Approvals in Dravet affection and LGS could aloof be the alpha for Epidiolex. Gover mentioned two added break that GW hopes to defended for its advance drug: tuberous sclerosis circuitous (TSC) and Rett syndrome.

GW expects to address abstracts from a cardinal appearance 3 abstraction evaluating Epidiolex in TSC in the aboriginal bisected of 2019. If those after-effects are positive, the aggregation affairs to book for approval in the adumbration in the additional bisected of the year. About 25,000 attack patients are afflicted by treatment-resistant seizures associated with TSC. 

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Gover additionally declared that GW affairs to admit a cardinal appearance 3 abstraction for Epidiolex in alleviative Rett affection in the additional division of this year. There are currently no FDA-approved treatments for the attenuate neurodevelopment disorder.

Obviously, Gover has abounding action to present the affairs for Epidiolex in the best absolute way he can. That’s his job. But I don’t anticipate his presentation was aloof fluff. 

Market analysis aggregation EvaluatePharma (as able-bodied as added analysts) anticipate that Epidiolex has blockbuster potential. My appearance is that Gover’s believability at the J.P. Morgan appointment accord believability to these projections. Epidiolex should be a big champ over time.

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Last Updated: January 13th, 2019 by mimin34
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