Jazz Pharmaceuticals To Acquire GW Pharmaceuticals, Creating An Innovative, High-Growth, Global Biopharma Leader

UNITED KINGDOM: Jazz Pharmaceuticals plc and GW Pharmaceuticals announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

Hot Pot Stocks: Aurora Cannabis vs. GW Pharmaceuticals. Which Cannabis Stock To Buy?

By Cristine Felt 

Aurora Cannabis vs. GW Pharmaceuticals: Which Cannabis Stock To Buy?

In this time and age when cannabis industry is simply blooming, it appears even an inexperienced rookie could try their hand at buying cannabis stocks and shares without the slightest fear of losing. Indeed, the global market is thought to be worth some astonishing $150 billion, with the prognosis of hitting $272 billion by 2028. You may have envisioned that world popular “shut up and take my money” meme already, but it’s not that simple (as usual). Stocks rise and fall, so it’s best to rely on the companies that have been around for a while and are doing a pretty good job, to say the least – Aurora Cannabis and GW Pharmaceuticals.

But which one is a tad better? Let’s make a brief comparison.

Aurora-Cannabis-LogoAurora Cannabis

Aurora Cannabis is a Canadian cannabis producer which was founded in 2013. The company deals with the production and distribution of medical and recreational cannabis. Just saying their business is based in Canada speaks volumes. Ever since the country has legalized cannabis use in October last year, the sales have been rising, and it was excellent news for experienced players such as Aurora Cannabis.

They had a 20% market share in the last quarter of 2018. As one of the largest marijuana producers, and with expectations to produce astounding 500,000 kilograms in the near future, it appears they are a force to be reckoned with. Moreover, Aurora is Germany’s main cannabis supplier, and this European country is expected to follow Canada’s suit soon. In addition, it also exports products to 20 other countries in five continents. What is more, the announced shortage of cannabis supply is without a doubt an excellent opportunity for the company. Their latest market cap is $9.042B.

But, what about the drawbacks?

For one reason, their overall business in 2018 was not as stable as it may have seemed. Their general performance was quite disappointing, and they were listed as one of top five worst Canadian cannabis stocks. The last quarter turned out great due to the consequences of the messy legalization, which Aurora benefited from.

gwphGW Pharmaceuticals

On the other hand, we have a British biopharmaceutical company and a true pioneer in the industry. They are globally well-known due to a product of theirs called Sativex, an oral spray that is extensively used in the treatment of multiple sclerosis. They reaped huge success with it, and it is sold as a prescription drug in the UK, EU, New Zealand, Israel and Canada. GW Pharmaceuticals was set up in 1998, and their vast research experience is bearing fruit once again with the latest breakthrough in medical cannabis industry in the form of Epidiolex. In its essence, this drug is a purified CBD, and one of the reasons why Epidiolex is a revolutionary prescription drug is the fact that it was recently approved by the U.S. Food and Drug Administration for patients suffering from different types of seizure. Bearing in mind its CBD content, this is definitely an unprecedented event. Obviously, the company has made a huge step into the US market and was recognized as trustworthy (even 2-year-olds are can be prescribed Epidiolex). Naturally, the sales are expected to skyrocket and reach $1 billion per year, or even $2 billion. By the way, GW Pharmaceuticals market cap is 5.131B.

So, everything seems to be going great, but… What the company did not prepare for, and it is a bit surprising bearing in mind their experience, is the huge demand for the new drug which has surpassed the expectations and caused the shares to drop by 3% (!). Which is worse, the doubt in their business management was triggered by a simple tweet of a dissatisfied father. It makes one wonder if GW Pharmaceuticals can rise to the challenge.

Taking everything into consideration, we believe that GW Pharmaceuticals’ future shines a bit more brightly than Aurora Cannabis’. The latter is definitely a huge producer and distributor, but GW Pharmaceuticals seem to be producing medical cannabis of such high quality that even the FDA had to approve of it. After all, the winners have always been those who were able to offer something unique, extraordinary and extremely high-quality, no matter the industry, and GW Pharmaceuticals appear to be one of them.

FSD Pharma Appoints Top GW Pharmaceuticals Executive As Chief Executive Officer

Management addition comes as FSD accelerates specialty cannabinoid pharmaceutical global expansion strategy

CANADA:  FSD Pharma announced today the appointment of Rupert Haynes as Chief Executive Officer. Mr. Haynes is a highly accomplished healthcare executive with nearly three decades of global pharmaceutical experience having most recently held the position of Head of Global Marketing at GW Pharmaceuticals in the United Kingdom. In his new role with FSD Pharma, Mr. Haynes will continue to work out of the United Kingdom, which will support FSD Pharma’s strategy of expanding its global footprint. Interim CEO and Co-chairman of the board, Dr. Raza Bokhari will remain in place as CEO until Mr. Haynes officially assumes the role.

“Mr. Haynes has an impressive track record in pipeline and product development which is directly relevant to FSD’s vision of becoming a global cannabinoid based pharmaceutical leader,” said Dr. Raza Bokhari, Co-chairman of the Board. “He blends world class specialty pharmaceutical experience with a fast-paced biotech mindset that will help accelerate FSD’s growth and global expansion strategy by assembling a top tier management team and pursuing targeted mergers & acquisitions. On behalf of the Board, I welcome him to the company.”

As head of Global Marketing at GW Pharmaceuticals, Mr. Haynes oversaw the strategic development of the firm’s cannabinoid portfolio including numerous cannabinoid pipeline products across dozens of therapeutic areas, but primarily neurological, neurodegenerative and neuropsychological conditions. Mr. Haynes was also involved in the strategic planning & development of Epidiolex®, an FDA-approved cannabidiol, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. Before GW, Mr. Haynes held numerous commercial roles, including senior leadership positions, at both large pharma and bespoke biotech firms which include Sobi, UCB Pharma, Bristol-Myers Squibb Ltd, UK, and Pharmacia & Upjohn Ltd, UK.

“This is an exciting time to be joining FSD,” said Mr. Rupert Haynes, CEO of FSD Pharma. “The company is advancing at a rapid pace having recently announced a pilot study for SCN-001 in irritable bowel syndrome through its collaboration with SciCann and intention to acquire Therapix Biosciences where there are active clinical trials evaluating cannabinoid combination therapies. I look forward to continuing this fast-paced pharmaceutical development which could lead to multiple significant new development programs in a very short timeframe.”

In October 2018, FSD announced its intention to acquire Therapix Biosciences to develop novel cannabinoid combination therapies in pain, migraine, and other CNS disorders. Therapix is currently evaluating THX-110, a proprietary combination drug based on dronabinol and PEA, in two ongoing Phase 2 studies in Tourette syndrome (Yale U. Medical Center) and obstructive sleep apnea (Assuta Medical Center) with a planned Phase 2 initiation in chronic back pain.

FSD partner SciCann Therapeutics, a company developing novel cannabinoid products for a range of diseases, recently announced initiation of a pilot study evaluating SciCann’s proprietary “Steady Stomach” cannabidiol combination product for the treatment of irritable bowel syndrome patients.

“We look forward to having Mr. Haynes at the helm of FSD as the company expands into the pharmaceutical industry,” said Anthony Durkacz, Co-chairman of the Board and Founder. “The Board believes that Mr. Haynes’ track record of product and pipeline development leadership on both a regional and international level, will support the transition of FSD into a global leader in the cannabinoid-based pharmaceutical space.”

“Mr. Haynes’ appointment as Chief Executive Officer builds on the incredible momentum at FSD Pharma this past year,” said Zeeshan Saeed, President and Founder. “We believe Mr. Haynes brings the vision and know-how to create long-term value for investors and new, effective treatments for conditions where there remains a need for therapeutic alternatives.”

Making Money From Marijuana

NEW YORK: Making money from marijuana in the past used to require navigating the red tape of the law.  Jim Cramer has had his eye on one stock that is giving him quite a buzz.

GW Pharmaceuticals is a speculative drug company that has a history of volatile trading. However, Cramer wouldn’t be surprised if the more than 10 percent jump in the stock on Wednesday is just the start of this stock being… high.

To find out where this stock could be headed, the “Mad Money” host sat down with Justin Gover, the CEO of GW Pharmaceuticals.

Cramer considers GW Pharma to be the one really legitimate play on medicinal marijuana, as it uses marijuana to develop real medicine. Additionally, it is a British company that doesn’t need to worry about the U.S. laws that make owning large quantities of pot a felony.

 

Marijuana’s Promise Of Profit Remains Elusive (For Now)

NEW YORK: Excitement surrounding medical marijuana led to a significant run-up in GW Pharmaceuticals‘ share price earlier this year, but based on the company’s recently announced quarterly and fiscal full-year earnings results, the promise of marijuana profit remains far off in the distance.

Planning for the future

That’s because GW Pharma has only one marketed marijuana derived therapy, Sativex, on the market, and Sativex, which is used to treat multiple sclerosis spasticity, has yet to win the FDA go-ahead for use in United States. As a result, sales of Sativex, which come primarily from European markets, total just $2 million in the quarter ending June and were small enough for the full fiscal year ending September that the company didn’t bother breaking them out in its quarterly earnings press release.

Instead, the company focused the bulk of its earnings report on the promising opportunity for its marijuana-based medicine across various indications and a slate of trials spanning cancer pain, epilepsy, schizophrenia, and even diabetes.

Those trials are all ongoing, so investors will need to rely on past trial data to make judgments on whether or not the market demand for GW Pharma’s medicine will justify the company’s $1.27 billion market cap.

Medical Pot: A Drugmaker Bets on Marijuana to Treat Diabetes, Epilepsy, and More

UNITED KINGDOM: Medicinal marijuana advocates contend that smoking pot helps relieve pain and alleviate nausea. British drug company GW Pharmaceuticals (GWP:LN) is betting that medicine made from cannabis can also treat maladies as diverse as diabetes, colitis, and epilepsy. [Read more…]