GW Pharmaceutical Archives - Green Market Report

StaffStaffFebruary 26, 2019
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6min7100

It’s time for your Daily Hit of cannabis financial news for February 26, 2019.

On The Site

GW Pharmaceutical

GW Pharmaceuticals plc (NASDAQ: GWPH) announced its financial results for the quarter ending December 31, 2018 reflecting the company’s first sales of its cannabis drug Epidiolex. The stock jumped almost 8% in after-hours trading as the biotech company beat analyst estimates. Net sales began on November 1 and between that day and the end of the year, the company logged sales of $4.7 million.

GW Pharmaceuticals changed its fiscal year to begin on January 1, 2019. The revenue for the quarter was $6.7 million versus $4.0 million for the same time period in 2017.  The average estimate for revenues from Yahoo Finance was $5.35 million.

Zynerba

Zynerba Pharmaceuticals, Inc. (ZYNE) stock popped over 8% in early trading to lately trade at $5.45 after the company announced that it had received a patent covering the company’s CBD gel.

The company said in a statement, “The U.S. Patent and Trademark Office has issued US Patent No. 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company’s cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel.”

In Other News

Purpose Investments Inc. announced the performance of Purpose Marijuana Opportunities Fund (the “Fund”) following the one-year anniversary of its inception. The Fund (NEO: MJJ) returned 53.43% over the period from January 31, 2018 to January 31, 2019, easily outperforming the Solactive North American Marijuana Index during the same period.

“The performance of Purpose Marijuana Opportunities Fund shows exactly why we believe active management is the most optimized way to invest in the cannabis sector,” said Greg Taylor, Chief Investment Officer of Purpose Investments and Portfolio Manager for the Fund. “Passive investing in a new industry, such as marijuana, often means chasing or missing opportunities because the indexes are rebalancing much more slowly than the market itself is moving. On the other hand, active investing allows you to capitalize on all of the opportunities while properly managing risks through a variety of different strategies and tactics.”

Marijuana Company Of America Inc.  (OTCQB: MCOA) announced that the United States Patent and Trademark Office issued the Company a patent for the formulation of its flagship CBD product, hempSMART Brain. hempSMART Brain is a wellness product formulated with a proprietary composition of natural ingredients and cannabidiol (CBD) for the enhancement of brain function. The U.S. Patent Office issued patent number 10,201,553. To view the patent on hempSMART™ Brain visit the link here.

Liht Cannabis Corp. (CSE: LIHT) (OTCQX: LIHTF) provided an “in-progress” update on the company’s first harvest in Las Vegas, Nevada. Kurt Keating, Director of Operations, reports, that the team has harvested close to 1000 plants to date, producing over 335 lbs of wet weight.  They are on schedule to complete the last two rooms by March 6th. The crop strains are: Bubba Kush, Moonshine Ghost Train Haze, Amherst Sour Diesel, Skywalker and Lemon Skunk.

Green Growth Brands, Inc. (CSE: GGB) (OTCQB: GGBXF) appointed Randy Whitaker as Chief Operating Officer, a new position within GGB. Mr. Whitaker has over 27 years’ experience in real estate, finance, and store operations.  Mr. Whitaker joins GGB from Belk, Inc. a privately held department store with over 293 locations.

Organigram Holdings Inc. (TSX VENTURE: OGI) (OTCQX: OGRMF) signed a letter of intent with the Société québécoise du cannabis (SQDC). This agreement solidifies the company’s position as a true national player in Canada’s legal adult use recreational cannabis marketplace. Organigram now has distribution in place for all ten Canadian provinces.


Debra BorchardtDebra BorchardtFebruary 26, 2019
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GW Pharmaceuticals plc (NASDAQ: GWPH) announced its financial results for the quarter ending December 31, 2018 reflecting the company’s first sales of its cannabis drug Epidiolex. The stock jumped almost 8% in after-hours trading as the biotech company beat analyst estimates.

Epidiolex Sales

Epidiolex is the first plant-derived cannabinoid pharmaceutical ever approved by FDA and first ever approved medicine in the U.S. for Dravet syndrome. Net sales began on November 1 and between that day and the end of the year, the company logged sales of $4.7 million. The company said there were approximately 4,500 new patient enrolment forms in the first two month selling period and over 500 physicians had generated dispensed prescriptions in the first two month selling period. Look ahead to 2019, prescriptions in January grew 150% sequentially over December.

Financial Results

GW Pharmaceuticals changed its fiscal year to begin on January 1, 2019. The revenue for the quarter was $6.7 million versus $4.0 million for the same time period in 2017.  The average estimate for revenues from Yahoo Finance was $5.35 million.  The net loss for the quarter jumped to $71.9 million versus last year’s$61.8 million for the same time period. The company also beat the analyst estimates for earnings by three cents with its loss of $0.20.

“We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year. As we move into the New Year, prescription growth trajectory has been highly encouraging and we believe that we are on track to deliver a successful market introduction of this important new treatment,” stated Justin Gover, GW’s Chief Executive Officer. “In addition to the US launch, we look forward to a positive regulatory decision in Europe in the next few months, results of a Phase 3 trial in Tuberous Sclerosis Complex, and a number of advances in the pipeline.”

 


Debra BorchardtDebra BorchardtNovember 26, 2018
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4min4660

Before Tilray (TLRY) and Canopy Growth (CGC) took over cannabis stock portfolios, GW Pharmaceuticals plc (Nasdaq: GWPH) was the darling of the group. However, the recent positive news from this cannabis biotech company’s epilepsy study serves to remind investors that great good comes from cannabis research.

On Monday, GW Pharma announced positive top-line results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of Epidiolex in the treatment of seizures associated with Dravet syndrome, a rare and severe form of childhood-onset epilepsy. The biotech company reported that in this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint of reduction in convulsive seizures for both dose levels (10 mg/kg per day and 20 mg/kg per day) with high statistical significance compared to placebo. The company said that both doses also demonstrated statistically significant improvements on all key secondary endpoints.

“The positive outcome in this second trial of Epidiolex in patients with Dravet syndrome further reinforces the effectiveness of this newly available medicine in this particularly difficult to treat, childhood-onset epilepsy,” stated Ian Miller, M.D., Director, Epilepsy and Neurophysiology Program at Nicklaus Children’s Hospital in Miami, FL and principal investigator of the trial. “The totality of data from the controlled clinical trials completed for Epidiolex have shown clinically meaningful seizure reductions and a consistent safety and tolerability profile.”

The drug was recently approved by the FDA and given a classification as a schedule five drug in September. Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

“The positive results from this trial follow the recent FDA approval, DEA rescheduling and U.S. launch of EPIDIOLEX for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome in patients two years and older. These data show an effective dose range in Dravet syndrome that is consistent with our FDA approved label, and which allows for dosing flexibility to address individual patient needs,” stated Justin Gover, GW’s CEO.

Study Results

The average age of the patients in the study was nine years. The patients were having approximately 12 convulsive seizures a month and approximately 35 total seizures per month. On average, patients were taking three anti-epileptic drugs (AED), having previously tried and discontinued on average, four other AEDs.

The statement said that during the treatment period, patients taking Epidiolex 20 mg/kg/day demonstrated a 46% reduction in convulsive seizures while patients taking Epidiolex 10 mg/kg/day achieved a reduction of 49%, compared to a 27% reduction in patients taking a placebo.
Results from the key secondary efficacy endpoints also showed statistical significance of both dose groups of Epidiolex compared to placebo, although the patients taking the placebo also experienced a drop in seizures. In the Epidiolex 20 mg/kg/day group, 49% of patients achieved a 50% or greater reduction in convulsive seizures from baseline over the treatment period, compared to 44% of patients taking Epidiolex 10 mg/kg/day, and 26 percent of patients taking the placebo.
Stock Performance
The stock jumped over 2% in pre-market trading having experienced a 52-week high of $179 in September, shortly after the change in scheduling. The stock closed on Friday at $124, above its year low of $105.

Debra BorchardtDebra BorchardtSeptember 27, 2018
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5min8780

The Acting Administrator of the Drug Enforcement Administration has placed FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols  (THC) in schedule V. GW Pharmaceutical’s (GWPH) Epidiolex had been a schedule I controlled substance, with this new directive Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance.

Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

The order made it clear that other cannabis products would remain in the schedule 1 category. The statement said, “As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” The document is scheduled to be published on September 28, 2018.

The order also said, “Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in
treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”

The order went on to stress that CBD material, “which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.”

Dr. George E. Anastassov, Chief Executive Officer of AXIM Biotechnologies remarked, “Today’s news is an important step for the pharmaceutical cannabinoid industry. It signifies an understanding on behalf of the regulatory agencies in the United States, such as the FDA and DEA, that cannabidiol (CBD) has therapeutic potential and a very low potential for abuse and misuse. However, this applies ONLY to Epidiolex, i.e. to the molecule contained within this particular formulation. Otherwise, CBD still remains as a Schedule I controlled substance and the current classification is non-applicable to the rest of the products available on the market.”

Thoma Kikis, Chief Communications Officer of Kannalife Sciences said, “The DEA’s rescheduling of Epidiolex from a Schedule I to a Schedule V controlled substance gives cannabidiol (CBD) more credibility and recognition as a treatment in the U.S. that does, in fact, have medical value. This is a watershed moment for the cannabinoid industry, and very encouraging for Kannalife Sciences and the work we have done to research and develop our own CBD-derived molecule (KLS-13019) for the treatment of diseases with unmet medical needs, such as Chemotherapy-Induced Neuropathic Pain (CINP), Hepatic Encephalopathy (HE), and Chronic Traumatic Encephalopathy (CTE). However, there is still more work to be done.”

GW Pharmaceutical stock jumped over 8% on the news to lately trade at $176.


William SumnerWilliam SumnerAugust 7, 2018
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3min6210

The London-based pharmaceutical company, GW Pharmaceuticals (GWPH), today announced the release of its financial results for the quarter ending on June 30, 2018.

During the last quarter, the company earned FDA approval for its cannabis-based drug Epidiolex in the treatment of seizures associated with LGS or Dravet syndrome. The company expects the FDA to reschedule Epidiolex within the next 90 days. Additionally, the company submitted Epidiolex for approval by the European Medicines Agency and a decision on the drug is expected to occur by the first quarter of 2017. The EMA has already granted Epidiolex Orphan Drug Status, so expectations are high.

With FDA approval, the company is currently gearing up for expanded facilities to meet expected long-term demand and commercial products are already being manufactured and shipped to the United States.

The company currently holds approximately $440 million in cash and cash equivalents, up from $312 million as of September 30, 2017. Revenue for the nine months ending on June 30, 2018, was $14.2 million, compared to $7.8 million during the same period in the previous year. Losses for the period rose from roughly $112 million to $180 million.

Earlier during the day, the company held a conference call to go over the financial results, and a recording of the call will be made available on GW’s website for the next 90 days. In a statement, Justin Gover, the Chief Executive Officer for GW Pharmaceuticals, hailed the FDA’s approval of Epidiolex as a major medical breakthrough.

“We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” said Gover. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”


StaffStaffAugust 7, 2018
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7min5240

It’s time for your Daily Hit of cannabis financial news for August 7, 2018.

On The Site:

Aurora Cannabis Inc.

Aurora Cannabis Inc. (ACBFF) today announced that it has entered into a letter of intent to acquire HotHouse Consulting Inc. Founded in 2004, HotHouse provides greenhouse consulting services and specializes in hybrid greenhouse growing techniques. Initially, the company focused primarily on agricultural clients, but in the ensuing years has shifted towards the cannabis industry. Under the agreement, the company has granted 1,940,000 options to buy shares of Aurora to officers of HotHouse, which will vest annually over the next three years and are exercisable at $7.39 per common share.

Navy Capital

New York-based cannabis-focused institutional fund Navy Capital Green International Ltd. invested $3 million of equity into  Nevada-based Oasis Cannabis. Oasis is an integrated cannabis producer and retailer in Nevada. It is also a subsidiary of CLS Holdings USA Inc., which operates as Cannabis Life Sciences.

Navy Capital said that it has an extreme interest in the CLS patented extraction and processing technology. According to the company statement, Navy Capital or select others may invest an additional two million with a 15% overallotment for a total of up to $5,750,000 by August 15, 2018.

In Other News

GW Pharmaceuticals plc

GW Pharmaceuticals plc (GWPH) reported its fiscal Q3 results for the quarter ending June 30, 2018, with revenue rising 34.6% to $3.5 million. The net loss fell 31.7% to a loss of $35.7 million. The company will be meeting with FDA in the back half of the year to clarify regulatory pathway for Sativex (nabiximols) in MS spasticity. GW Pharma will also begin to study CBDV in autism this quarter.

“The recent FDA approval of Epidiolex represents a major medical advance for patients with Lennox-Gastaut Syndrome and Dravet syndrome. We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” stated Justin Gover, GW’s Chief Executive Officer. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”

22nd Century Group, Inc.

22nd Century Group, Inc. (XXII), a plant biotechnology company that is focused on tobacco harm reduction, Very Low Nicotine tobacco, and hemp/cannabis research, announced its second quarter 2018 financial results. The company posted net sales revenue of more than $6.9 million and significantly increased spending – to more than $2.7 million this quarter – on the Company’s Modified Risk Tobacco Product (“MRTP”) application to the U.S. Food and Drug Administration (“FDA”) for “BRAND A” Very Low Nicotine cigarettes. As of June 30, 2018, the Company had more than $53 million in cash and short-term investments, which are sufficient reserves to meet regular operating expenses for a number of years.

The company had a net loss for the three months ended June 30, 2018, of $6,739,000, or ($0.05) per share, as compared to a net loss of $3,356,000, or ($0.04) per share, for the three months ended June 30, 2017. The increase in the net loss for the second quarter of 2018 of $3,383,000, or 100.8%, was due primarily to the net increase in the operating loss of $3,758,000.

Arena Pharmaceuticals, Inc. 

Arena Pharmaceuticals, Inc. (ARNA) reported a net loss of 65 cents per share or  $31.8 million for the second quarter of 2018 versus last year’s loss of 77 cents per share. It was wider than the Zacks Consensus Estimate of a loss of 62 cents. Revenues totaled $4.0 million, consisting of $3.1 million in collaboration revenue, and $0.9 million in royalty revenue. At June 30, 2018, Arena’s cash, cash equivalents, and investments balance were $592.4 million and approximately 49.3 million shares of Arena common stock were outstanding.

“We have made significant progress over the past three months across our clinical programs, including the initiation of our ADVANCE Phase 3 program for ralinepag in patients with PAH. We are excited for the opportunity to potentially advance the treatment paradigm for patients suffering from this critical illness,” said Amit D. Munshi, President and CEO of Arena. “Additionally, we are pleased to have submitted our meeting request to the FDA for etrasimod in UC, and look forward to the data readout from our Phase 2 study of olorinab for pain associated with Crohn’s disease in September.”

NUGL Inc.

NUGL Inc. (NUGL) announces its North American Marketing Strategy. NUGL’s platform delivers exclusive profiles and features for brands and listings in the cannabis space leading search app offers every type of cannabis company and professional service the ability to create individual profiles for marketing, connecting and expanding client bases in and out of the NUGL community. NUGL’s platform also gives brands and listings cutting-edge software that helps their business expand their client base and network.


Debra BorchardtDebra BorchardtJune 25, 2018
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5min5860

It’s time for your Daily Hit of financial cannabis news for June 25, 2018.

On The Site

GW Pharmaceuticals

If any other company released any news today, then it went basically unnoticed because the FDA approved GW Pharmaceutical’s (GWPH) cannabidiol drug Epidiolex. The news was expected sometime this week, so it was nice of the FDA to just get it out of the way on Monday. According to the press release, this is the first FDA-approved drug that contains a purified drug substance derived from marijuana and it is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.

Even though the FDA has now approved the use of Epidiolex as a real treatment for these diseases, it doesn’t immediately change the status of cannabis as a controlled substance. The FDA did not say in its release whether it had delivered a recommendation to the DEA regarding Epidiolex and its schedule status.

However, in GW Pharmaceutical’s statement, the company said it would have to be rescheduled before it could be made available to patients. “Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded AEDs and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.

Marapharm Ventures

Marapharm Ventures Inc.  (MRPHF)  announced that it has entered into a Letter of Intent dated June 21, 2018 to purchase all the shares of  Full Spectrum Medicinal Inc. Marapharm will have until September 30, 2018, to conduct due diligence on Full Spectrum, with a view to negotiating the terms of a definitive agreement in order to complete the transaction. The company did not provide a valuation for the proposed transaction.

In Other News

Harvest One Cannabis Inc.

Harvest One Cannabis Inc. (TSXV: HVT) has signed a binding Share Sale Agreement with Australian-based MMJ PhytoTech Limited for the purchase of 100% of Israeli-based PhytoTech Therapeutics Ltd. The transaction will be a combination of cash and shares. Upon completion, $1 million in cash and $7 million in Harvest One common shares issued at the then 10-day volume weighted average closing price, will be paid to MMJ.

Cronos Group Inc.

Cronos Group Inc. (CRON)  announced that it entered into a strategic distribution partnership with privately owned pharmaceutical wholesaler Delfarma Sp. Zo.o. Founded in 2004, Delfarma was the first company in Poland to introduce international parallel import of medicinal products from European Economic Area countries. Delfarma distributes directly to over 5,000 pharmacies and more than 200 hospitals, a distribution network that reaches approximately 40% of the Polish domestic market.

Hiku Brands

Hiku Brands (HIKU.CN) announced that it has been granted permission for ten stores by the Province of Manitoba. Four of the stores will be located in Winnipeg and one in Brandon, all of which will be opened under our award-winning cannabis retail brand Tokyo Smoke, winner of Cannabis Brand of the Year at the 2017 Canadian Cannabis Awards.

Hiku is actively working with various regulators, provincial and municipal governments in the Province of Manitoba to obtain the necessary permits for our proposed Tokyo Smoke stores and will ensure location specific permission prior to announcing our chosen locations. This announcement is in addition to Hiku’s announcement on June 22, 2018 on the update for Alberta retail storefronts which detailed how Hiku has filed applications for more than a dozen storefronts in Calgary and are at the top of the list to be considered in each of those locations following Calgary’s first come, first serve approach to licensing.  As previously announced, Hiku has also entered into a letter of intent with Oceanic Releaf Inc., a late-stage applicant under the ACMPR in Newfoundland & Labrador, pursuant to which Oceanic and Hiku are working with the government on the approval for Oceanic of up to 5 additional stores in that province.

 

 


Debra BorchardtDebra BorchardtJune 25, 2018
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8min25371

The U.S. Food and Drug Administration (FDA) approved GW Pharmaceuticals’ (GWPH) cannabidiol (CBD) drug Epidiolex as an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. According to the press release, this is the first FDA-approved drug that contains a purified drug substance derived from marijuana and it is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.

“Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older,” said FDA Commission Scott Gottlieb, M.D.

He went on to add, “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”

Gottlieb cautioned though that he remains concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. The FDA has taken action against companies making unsupported CBD claims in the past couple of years and the agency said it would continue to do so.

GW Says Rescheduling Within 90 Days

Even though the FDA has now approved the use of Epidiolex as a real treatment for these diseases, it doesn’t immediately change the status of cannabis as a controlled substance. The two defining factors of the schedule one designation include not having a medicinal purpose and being a highly addictive drug.

The FDA release stated, “Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD. The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.”

The FDA did not say in its release whether it had delivered a recommendation to the DEA regarding Epidiolex and its schedule status.

However, in GW Pharmaceutical’s statement, the company said it would have to be rescheduled before it could be made available to patients. “Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded AEDs and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.”

“While we applaud the FDA for confirming what many of us have long known–that the benefits of cannabis are immense–we do find it a bit comical that the federal government now contradicts itself once again,” said Chris Driessen, President of Organa Brands U.S. “While the FDA touts the benefits of this new drug, the DEA maintains a Schedule One classification for cannabis, stating that it has no medical application and a high potential for abuse. We have to ask–does the left hand know what the right hand is doing?

Management Comments

“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s Chief Executive Officer. “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” said Orrin Devinsky, M.D., of NYU Langone Health’s Comprehensive Epilepsy Center and a lead investigator in the EPIDIOLEX clinical program. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”

“For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a true medical advancement,” said Philip Gattone, president and CEO of the Epilepsy Foundation.  “Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures.”

Epidiolex

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. It uses CBD, which is a chemical component of the Cannabis sativa plant. CBD does not give patients a psychotropic effect like getting “high” that comes from the other part of the cannabis plant –  tetrahydrocannabinol (THC).

 


William SumnerWilliam SumnerMay 17, 2018
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3min12260

The biopharmaceutical company GW Pharmaceuticals (GWPH), along with its U.S. subsidiary Greenwich Biosciences, announced the publication of its Phase 3 study of cannabidiol oral solution in patients with Lennox-Gastaut syndrome (LGS) in The New England Journal of Medicine.

Announcing positive results, GW CEO Justin Gover hailed the study’s publication as another landmark moment for the company and touted its results as further proof of the cannabidiol’s potential in the treatment of LGS.

“We are now in the latter stages of the FDA`s review of our New Drug Application and look forward to a decision from FDA in late June,” stated Gover. “If approved, we expect to make this important potential new medicine available to U.S. patients with LGS in the second half of the year.”

In a double-blind, placebo-controlled trial conducted at 30 clinical centers, researchers randomly selected 225 patients diagnosed with LGS, with an age range of 2 to 55 years, who had two or more drop seizures per week. The patients were divided into three groups. One group comprised of 76 patients would receive a 20mg dose of Epidiolex, the company’s proprietary cannabidiol-based medicine, twice a day for two weeks. The second group, which was comprised of 73 patients, would receive a 10mg of Epidiolex twice a day for two weeks,. The third group, which had 76 patients, was given a placebo.

During the 28-day baseline observation period, the combined average of drop seizures for all groups combined was 85. After treatment, the group treated with 20mg of Epidiolex experienced a 41.9% reduction in seizures, while the group that received a 10mg does experience a 37.2% reduction. The placebo group only saw a 17.2% reduction in drop seizures.  Sides effects from taking Epidiolex included drowsiness, reduced appetite, and diarrhea; all of which were more pronounced in the group taking the higher dose. A total of six patients from the 20mg group and one patient from the 10mg had to withdraw from the study due to the side effect. Additionally, 14 patients who received Epidiolex had elevated liver aminotransferase concentrations.

Stock Performance

News of the study’s positive results has created a surge in GW’s stock price at the open only to trim those gains as the morning went on. The stock is currently trading at an all-time high of $150.68 per share. It is nearing the average analyst price target of $155.50 according to Yahoo Finance.


Video StaffVideo StaffApril 20, 2018

5min12860

Happy 4/20 everyone. It’s the day the cannabis industry likes to celebrate as their special holiday. It’s become a huge business deal for the industry.

A recent study done by LeafLink predicts that this 4/20 will be the first ever to have retail sales top $1B, even reaching as high as $1.2B, based on their wholesale marketplace figures. According to Flowhub, in 2017, total sales of cannabis by consumers on 4/20 represented a 44 percent increase from an average Thursday and 30 percent more than an average Friday.

The big news this week had to do with biotech company GW Pharmaceuticals. The company received very positive comments from the FDA. That left many market watchers with the feeling that the FDA will ultimately approve GW’s drug epidiolex for pharmaceutical sales in the U.S. While some believe this means that marijuana would immediately be removed from the controlled substances list. Think again. That still has to be done by Congress. However, it’s hard to argue that marijuana has no medicinal purposes, which is part of the schedule 1 designation if you can get a legal prescription for it.

Green Bits, headquartered in San Jose, announced it has raised a $17 million Series A funding round, led by Tiger Global, the New York-based investment firm, along with participation by Snoop Dogg’s Casa Verde Capital.

Medicine Man Technologies (MDCL) announced today the preliminary financial results for the quarter The company reported approximately $1.2 million in revenue for the quarter, a 122% increase over the same quarter last year and representing the fifth consecutive quarter of revenue growth.

Ontario-based Aphria Inc. (APHQF) reported that its revenues for the third quarter ending February 28 were C$10.2 million versus last year’ C$5.1 million for the same time period, an increase of 100%. Revenue increased 20% sequentially from C$8.5 million.

MassRoots filed its annual report on Tuesday but didn’t get around to the company’s financials in the filing until page 24. Gross revenue for the year fell 54% to $319,242, while the net losses ballooned 146% to $44 million. In all of this mess, CEO Isaac Dietrich awarded himself a bonus of $190,659 on top of his salary of $96,971. While Mr. Dietrich’s monthly salary was decreased from 2016, his total compensation jumped from $107,917 in 2016 to $287,630 in 2017.

Lots of acquisitions to report…..

MPX Bioceutical Corporation  (MPXEF)  signed a letter of intent to acquire all the issued and outstanding shares of private company Canveda Inc., a Licensed Producer under Health Canada’s Access to Cannabis.

CannaRoyalty  is buying FloraCal Farms (“FloraCal”), a licensed ultra-premium craft cannabis producer located in Sonoma County, California for US$1 million and 3,million + CannaRoyalty shares

Livewell Foods Canada announced that it entered into a C$10 million private placement deal.

Civilized Worldwide Inc. announced that it executed a strategic investment and collaboration agreement with Canopy Rivers Corporation where they will invest C$5 million in Civilized via a convertible debenture and the companies will work together on various online, media and event mandates relating to the cannabis industry.



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