GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) Files Marketing Authorization Application For Epidiolex® In Europe

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) has submitted its Marketing Authorization Application to the European Medicines Agency for Epidiolex® as adjunctive treatment for seizures related with Dravet syndrome and Lennox-Gastaut syndrome, two extremely treatment-resistant types of childhood-onset epilepsy.

The details

GW Pharmaceuticals has obtained Orphan Designations from the European Medicines Agency for Epidiolex for the cure of Dravet syndrome, LGS, and lately, West syndrome & Tuberous Sclerosis Complex. In October 2017, the company completed the filing of its rolling Epidiolex NDA to the United States FDA, also for seizures linked with Dravet syndrome and LGS. This NDA has been approved by the FDA for Priority Review.

Justin Gover, the CEO of GW Pharmaceuticals, expressed that this Marketing Authorization Application filing marks another key milestone for the Epidiolex plan and is a vital next step toward offering this prospective new treatment option internationally. The company is dedicated to making Epidiolex available to people in Europe that fight with the burden of living with Dravet syndrome and LGS, both extremely difficult to cure and devastating conditions. They continue to establish a commercial infrastructure in Europe in expectation of future approval and release.

The MAA filing for Epidiolex is supported by report from three Phase III efficacy and safety trials, each of which fulfilled their primary objective. Epidiolex was usually well tolerated in these studies. The MAA comprises safety data on around 1,500 patients, with around 400 people on continuous therapy for over one year. Around 26% of the people suffering from Epidiolex from the Phase III pivotal plan came from European sites. Beyond pivotal efficacy and safety data, the MAA comprises a comprehensive clinical pharmacology, toxicology and pre-clinical package.

In unrelated news, the GW Pharmaceuticals posted that the U.S. FDA has accepted its filing for Priority Review of its New Drug Application for Epidiolex®. The PDUFA goal date for FDA completion is June 27, 2018.


Can GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) Move Towards North?

In the last trading session, the stock price of GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) closed marginally in green, indicating that the stock may attempt to recoup its last week losses. Earlier in October, the company reported that it has closed the rolling submission of a NDA to the USFDA for Epidiolex® as adjunctive treatment targeting seizures associated with LGS and Dravet syndrome. This task was closed along with the help of company’s subsidiary unit – Greenwich Biosciences.

The details

GW Pharmaceuticals has been granted with Rare Pediatric Disease as well as Orphan Drug Designations from the USFDA for Epidiolex in the treatment of Dravet syndrome and LGS. Additionally, it has been given Fast Track Designation from the USFDA for Epidiolex for the cure of Dravet syndrome. Justin Gover, the Chief Executive Officer of GW Pharmaceuticals, expressed that the filing of the Epidiolex NDA is a significant achievement for people suffering with LGS and Dravet syndrome.

This indicates that there is a potentially new treatment option in horizon for these two difficult to treat and grave conditions. On behalf of company’s employees, patients and clinicians, who have been a part of the Epidiolex plan, they are pleased to file the NDA for this promising therapy for U.S. FDA review. The team look forward to offer every support to the FDA throughout the assessment course. This regulatory submission is an indication of GW’s commitment to developing unique cannabinoid-based treatments. The company is currently assessing additional clinical development plans in other orphan seizure disorders.

The NDA for Epidiolex goes with on the back of data from three Phase III safety and efficacy trials, each of which achieved their main endpoint. GW Pharmaceuticals intends to file a Marketing Authorization Application in Europe for Epidiolex in the imminent future. Epidiolex is a pharmaceutical formulation of purified CBD, which is in development for the cure of numerous rare childhood-onset epilepsy ailments.


SinglePoint, Inc (OTCMKTS:SING) Directs Its Efforts To Accelerating Growth In Cannabis Sector

The stock of SinglePoint, Inc (OTCMKTS:SING) closed at $0.073 losing 8.25% in yesterday’s trading session. This provider has recently been seen to pay much focus to accelerated growth in Cannabis sector and it targets to make its impact felt globally.

One of its greatest moves has been the signing of a letter of intent in which it expressed its interest towards the acquisition of Dr. FeelGood. This is a rather profitable medical marijuana distribution that has for pretty long indicated its commitment to setting up a proprietary delivery and ordering technology. SinglePoint remains optimistic that the new acquisition will help towards boosting it revenue stream.

The provider is confident of closing this acquisition soon and that will give a proper demonstration of the company’s ability to develop its portfolio of investments in established high-growth, high-potential cannabis enterprises. Earlier this year, this company succeeded in the acquisition of some two companies and asserts that the latest acquisition will be a significant addition to its portfolio.

SinglePoint CEO, Greg Lambrecht opined, “We are well capitalized to continue acquisitions and we are optimistic to complete around three more acquisitions and significantly increase the company’s revenue.”

He added that the company was in a better position, something that they have been looking forward to for quite long.

The President of Dewmar International BMC Inc (OTCMKTS:DEWM), J.D. Houston has expressed his willingness to attend the upcoming conference. The MJAC 2017 will be providing the various retail investors with a perfect opportunity to access crucial business insight on firms in the cannabis sector.

The shareholders that will be attending the meeting will learn much regarding Dewmar’s cannabis business setup from revenue generating services and products to portfolio of IP assets. The president is also expected to have a word with managers of micro-cap funds who have indicated their interest towards investing in firms like Dewmar.

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) recently gave its latest update on the Q3 2017 Financial Performance. The NDA filing procedure for Epidiolex is already up and running and most probably by October the final sections of the filing will be at the verge of completion.


The American Academy Of Neurology Releases Its Data Regarding Epidiolex® (Cannabidiol) As GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) publicizes the matter

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) happens to be a biopharmaceutical provider focusing on the discovery, development as well as the commercialization of a wide spectrum of therapeutics from its proprietary cannabinoid product platform.

The company through one of its top executives has come forward to make public American Academy of Neurology (AAN)’s issuance of the positive results associated with a second Phase 3 study (GWPCARE3) of Epidiolex® (cannabidiol or CBD) among adults and children as well who are struggling with Lennox-Gastaut syndrome (LGS).

According to some close sources, the data will most probably be presented during the forthcoming meeting linked with the American Academy of Neurology (AAN) situated in Boston, MA. The announcement from a speculative point of view is sure to put a smile on the faces of the large number of patients struggling with related complications.

As a matter of fact, the Lennox-Gastaut syndrome happens to be one of the trickiest types of epilepsy for medical experts to deal with. It was disclosed from the placebo-controlled research that indeed Epidiolex is observed to clinically provide significant reductions in an acceptable safety and tolerability profile in line with the seizure frequency.

According to one of the provider’s top executives, Epidiolex has the capacity to offer a positive change towards dealing with LGS .On that same note, he moved ahead to show his great excitement following the plans the company had put in place in the future prescriptions.

It goes without saying that what any top company needs to ensure is the setting up of a more standardized as well as a tested pharmaceutical formulation of cannabidiol. That will help a huge deal towards helping patients around the globe.

The trial set up revealed that indeed Epidiolex was from a general perspective well tolerated. However, the recent Phase 3 Study had showcased a pattern of some adverse events that had remained quite persistent over time.

It was a great thing that during a prestigious meeting there was the highlighting of the Phase 3 epilepsy program, and that the wide neurological community needed to pay closer attention as a matter of fact!


GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) CEO To Present At The Annual Healthcare Conference

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) CEO Justin Gover will present at the upcoming Cowen and Company Annual Healthcare Conference on March 8, 2017. Several new drugs and therapies are being advanced at a rapidly increasing pace in the Cannabidiol market such as the application of phytocannabinoids to avoid an array of numerous medical conditions and ailments.

As increasing number of states have approved medicinal marijuana applications in the United States and Canada, Cannabis firms involved in research and development activities in cannabinoid medicinal applications and clinical studies continue to move ahead despite the Federal indications of a likely crack down on recreational pot use.

Biotech and cannabis stocks with latest industry developments comprise GW Pharmaceuticals and many other firms like Earth Science Tech and Insys Therapeutics.

The buzz

GW Pharmaceuticals proclaims itself as a biopharmaceutical corporation that engages in discerning, advancing, and commercializing CBD prescription medicines. It works through three divisions: Sativex Research & Development and Pipeline R&D. The firm mainly offers Sativex, which an oromucosal spray for the cure of spasticity occurring as a side-effect to multiple sclerosis.

GW Pharmaceutical is also focused on the Phase 3 clinical development plan of Sativex for application in the cure of cancer pain; and Phase II studies in other indications, like neuropathic pain. Additionally, the firm’s product pipeline comprises Epidiolex, a cure for Lennox-Gastaut syndrome and Dravet syndrome, as well as other offerings in Phase I and II clinical advancement for the cure of glioma, type-2 diabetes, schizophrenia and adult epilepsy.

It has its work spread in the United Kingdom, Europe, Canada, Asia and the United States. The company was instituted in 1998 and is based in the United Kingdom.

In the last trading session, the stock price of GW Pharmaceuticals over 1% to close the session at $128.99. The market cap of firm stands at $2.81 billion.


Goldman Sachs Has A Buy Rating On GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH)

Goldman Sachs initiated coverage on GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) with a “Buy” rating and price target of $189. Four other groups lately updated their coverage. The target range as noted from the released reports is from $135 to $208. The firm’s lead product candidate is ‘Epidiolex’ for the cure of epilepsy. It anticipates to submit its U.S. marketing application in the upcoming period.

The buzz

An emerging stringent payer line on new medications for rare diseases should pose questions about the strategy of firms that have put their investment cases on robust pricing power. Anthem Inc (NYSE:ANTM) choice this month to restrict coverage of Spinraza is as per its earlier decision to not to pay for Exondys 51. Both are therapies for rare degenerative disorders in kids.

This ought to increase some worries about market entree for late-stage orphan drug contenders being advanced by firms like GW Pharmaceuticals, bluebird bio Inc (NASDAQ:BLUE), BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), 11 agents with total anticipated sales of $6 billion will reach Phase 3 or regulatory achievements this year.

The FDA’s broad nod for Spinraza in spinal muscular atrophy kicked the question of subject eligibility to payers. Anthem has determined to restrict its use to subjects confirmed to have definite SMN mutations and who showed SMA indications before they were 6 months old, mainly meeting the findings of clinical studies conducted by Biogen.

With a price tag of $125,000 per injection, Spinraza was sure to draw scrutiny. In earlier years, the relative scarcity of SMA, EU prevalence is expected at 20,000 people, might have convinced payers to be easy on it after evaluation. But heightened sensitivity related to drug costs has encouraged payers to test the price of even rare disease medications.

This is led in no small part by the particular sector’s movement to rare disease agents as in the past they have provided a healthier return on investment.

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