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Feb 5, 2018 Update

nasdaq:gwph

#1
GW Pharmaceuticals Announces the European Medicines Agency (EMA) Accepts Epidiolex® (cannabidiol) Marketing Authorization Application (MAA) for Review

FEB 5, 2018
MAA seeking regulatory approval of Epidiolex for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome

LONDON and CARLSBAD, Calif., Feb. 05, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (¿GW,¿ ¿the Company¿ or ¿the Group¿), a biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform, announced today that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Epidiolex® (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. This acceptance follows submission of the MAA in December 2017.

¿The successful filing of the MAA for Epidiolex with the EMA builds on the momentum of acceptance by the U.S. Food and Drug Administration of the Epidiolex New Drug Application in December and recent publication of Phase 3 LGS results in The Lancet,¿ said Justin Gover, GW's Chief Executive Officer. ¿We continue to build European commercial infrastructure in anticipation of future approval and launch with the goal of making this important new medicine available to appropriate patients and their caregivers, addressing the significant unmet need in LGS and Dravet syndrome, two rare and debilitating conditions of childhood-onset epilepsy.¿

The outcome of the MAA review by the EMA is expected in Q1 2019. In preparation for the commercialization of Epidiolex in Europe, GW continues to hire staff in the areas of medical affairs, market access and marketing, all with strong epilepsy or specialist disease experience. Significant progress has been made in hiring country leadership and local medical staff in the five major European markets. This European commercial effort is being led by Chief Operating Officer Chris Tovey, who has significant experience commercializing and launching pharmaceutical products, including within the field of epilepsy.

About Lennox-Gastaut Syndrome

The onset of LGS typically occurs between ages of 3 to 5 years and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and genetic neuro-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 and convulsive seizures, which frequently lead to falls and injuries, and non-convulsive seizures. Resistance to anti-epileptic drugs (AEDs) is common in patients with LGS. Most children with LGS experience some degree of intellectual impairment, as well as developmental delays and aberrant behaviors.

About Dravet Syndrome

Dravet syndrome is a severe infantile-onset and highly treatment-resistant epileptic encephalopathy frequently associated with genetic mutations in the SCN1A sodium channels. Onset of Dravet syndrome occurs typically during the first year of life in previously healthy and developmentally normal infants. Initial seizures are often body temperature related, severe, and long-lasting. Over time, patients with Dravet syndrome often develop multiple types of seizures, including tonic-clonic, myoclonic, and atypical absences and are prone to bouts of prolonged seizures including status epilepticus, which can be life threatening. Risk of premature death including SUDEP (sudden unexpected death in epilepsy) is elevated in patients with Dravet syndrome. Additionally, the majority will develop moderate to severe intellectual and development disabilities and require lifelong supervision and care. There are currently no FDA-approved treatments and nearly all patients continue to experience seizures and other medical needs throughout their lifetime.

About Epidiolex® (cannabidiol)

Epidiolex, GW's lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome, which has been assigned a goal date of 27 June 2018 and, if approved, the medicine is expected to be available by prescription in the second half of 2018. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in early 2019. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms.

About GW Pharmaceuticals plc and Greenwich Biosciences

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, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA and an MAA with the EMA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in 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 numerous 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 gliobastoma, schizophrenia and epilepsy. 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® (cannabidiol) 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 and uncertainties related to the regulatory process, and the acceptance of Sativex, 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 4 December 2017. 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.

©2018 GW Pharmaceuticals, plc. All rights reserved

Will (PS: Ripley, Thanks & yes you can)


#2

Big falls yesterday in stock market ( USA ) 3%.
But i was not able to top up @ 130.


#3

After not being able to find a bargain in London on today’s big fall back in world markets thought id set a low 125 buy in here but only half of recent buy backs.
I am always to cautious when i should be brave went out just back lifted on open and now nearly 4 higher .
Still I’m a self learner its a wonder i don’t lose lol


#4

News today of MPs calling for boy with epilepsy to be given medical cannabis license.
Not sure if the GWPH trails cover epilepsy ?


#5

#6

Well done for link Peter ( is that your politics or your team ? )
Afraid i’m not up to speed with computers so can not add links.
Good to see more posters any view ( holder ? )
No dealing today i think it a public holiday USA celebrating Donald Trump :- )


#7

The link is generic in only stating ‘cannabis oil’ that could/was obtained abroad and it dramatically reduced seizures for the 6 year old boy who was having up to 30 violent seizures a day!!!

The MP/Political comments indicated a major lack of understanding regarding medicinal cannabis.

The beneficial use of ‘cannabis oil’ as given to the 6 year old was clearly aimed at Sativex for medicinal use. It is only a matter of time the it will gain world wide acceptance following current trial results, and my expectation is in 2018 or 2019 at the latest.

Will (GL to all holders)


#8

GWPH…
XXXX
I am not a fan of the new ii site .
News story’s of Irish lad having his medical cannabis oil confiscated at heathrow, now given it back after some weeks.
The story of Theresa Mays husband having a 22% holding here has come up … sativex mentioned.
i’ve not really looked at it for a few months had gone up a good bit before recent pull back.


#9

GWPH…
XXXXX
This had a great May 2018 rising to 160 $ i thought all the news was a good in June, but what do i know .
Back down now to April levels of 137 .
Anyone buying the dip ?


#10

GWPH…
XXXXX
Fell back to near $130 this week that might be new bottom .
Nearly down to my last top up Feb 6th.
And i thought it had made good progress with some good news.


#11

GWPH…
After bouncing of $ 130 a month ago its heading back down $132 today .
Might revisit my last slice price @ $ 125.


#12

GWPH…
XXXXX
lots of news on Marijuana shares this weekend .
Including something sent by ADVFN … Atlanic Advisory report.
I was surprised there were so many there is a Marijuana index.
GWPH is third on it by market cap.
There are a few Marijuana collective investments .
Looks like Canopy growth corp ( weed ) lol was the one to be in, gone up ten fold last two years.
Its the largest by Market Cap ( makes GWPH look a poor investment by comparison )
Any views ?
Another couple of company’s like GWPH in the biotechnology sector and not directly into Marijuana are ZYNE and INSY has anyone any knowledge on either of these.


#13

GWPH…
New highs today 166.5
( 20th ) Didn’t look at this "note " opened $155 put limit on for a slice @ $165 which lifted within the hour when out at bank.
( 21st ) Villafan has posted it went to 173.70 all time high yesterday . ( i had thought i saw 175 )
fell back today below my slice yesterday .


#14

Yes, bit of a downslide yesterday. Unclear as to why, though a lot of the ‘pot’ stocks were also retracing, perhaps because of the crazy activity with Tilray this week. Epidiolex expected to get its own scheduling by DEA which reading between the lines suggests that cannabis or CBD will not be rescheduled. This could be even move favourable for GWPH. I feel that once Epidiolex is scheduled we will see the big pharmaceuticals getting involved in cannabis meds. GWPH will surely be even more attractive for a takeoever. Deadline for DEA scheduling is Sunday.


#15

GWPH…
XXXX
Thankyou for sharing information villa .
Surprised Sunday is deadline when do you think news will come .
Just looking down the page i see you have been on here for longer than i thought .
The old GWP posts disappeared so id have to look at paper records to see when i first bought these .
By best ever selection .
Will Scarlet used to post more often , Just seen Norman Barrington is first post here 2013 ( years before transfer ! )
( Record since transfer in all multi s 1st )
I see an old post of mine here saying i was just going to forget about this one and be patient maybe something for me to take in there.


#16

Hi Ripley. Yeah I’ve been pretty quiet lately on here, but only because I’m finding the new ii format difficult to adjust to! GW has tried my patience at times and I often wondered if I’d made a mistake investing (around 4 years ago). I very nearly sold (at a loss) when they announced they were moving to nasdaq. It must’ve been sixth sense telling me to go with it, but I’m glad I did. My thoughts… GW has a very bright future indeed. ‘Pot’ stocks are popping up almost on a weekly basis. As you rightly stated weeks ago there’s now an mj index of sorts. Of course GW is a pharma company, but there’s tonnes of small mj firms emerging and claiming to do research into meds. This is good and the recent media exposure must surely have large pharmaceutical companies very interested indeed in the sector. I believe the reason they’ve not got on board is the whole issue of mj classification here, Europe, US, and the fact we’ve all been led to believe there’s no medicinal value in mj! The fact that GW got FDA approval for Epidiolex was a huge hurdle, and if as expected it gets its own scheduling by DEA I believe this will be a game-changer for the company. If it gets its own scheduling it means there’ll be no plans to reschedule mj. This is great for GW. Epidiolex and Sativex are blockbusters! Sativex will probably get US FDA approval, and subsequently DEA scheduling. Europe will no doubt replicate this. And as for UK, the press exposure of the epileptic children denied mj will surely mean that Sativex is made more widely available across NHS. I would bet that once Epidiolex is DEA scheduled, we’ll see large pharmaceuticals getting into mj and I reckon GW will be taken over. GW has a promising pipeline and over the last few years it’s been ‘quietly’ acquiring a long list of patents! I bet you’re glad you held aren’t you?


#17

Yes its covered some big losses this year , FLOW and CLLN , just two of them lol .
Maybe picking a few good ones putting away and only looking a couple of times a year is a good way of making money in shares ?


#18

That sounds like a good strategy! LOL DEA deadline was reported in press as being Sunday, but according to US discussion boards the announcement will probably be Mon or Tues. Although the shareprice might pull back later in the week we could see it going up to the $180’s on the news.


#19

More good news. Medicinal Cannabis just got rescheduled in UK (21st September). This should now start generating sales in UK from Sativex. Happy days! https://www.gov.uk/government/news/government-announces-definition-for-cannabis-based-products-for-medicinal-use


#20

GWPH…
XXXXX
All the mucking about slicing and topping not so smart in hindsight i am 30 shares down from conversion .
They never did fall back below the 130 resistance end of July / August.
However i do have a large holding 8 times more than what i like to have in one share.
But that’s because they have done so well.
On reflection im happy with my actions here, i was regretting not slicing in May but that looks lucky now … Davids right put away and forget about them “just too time consuming” trying to be clever and no guarantee of being better off for it.