GW Pharmaceuticals to expand marketing authorization for Sativex to France

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW" or the "Company"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorization for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).

This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.

Sativex is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK,Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with launches currently in preparation for a further 8 European countries, as well as Australia and New Zealand.

Sativex meets a significant unmet medical need for patients with Multiple Sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe. We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with Multiple Sclerosis."

Almirall, an international pharmaceutical company with headquarters in Spain, is the exclusive distribution partner for Sativex in the European Union (excluding the United Kingdom) and E.U. accession countries, as well as Switzerland, Norway, Turkey and Mexico.

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Cannabidiol (CBD): Fighting Inflammation & Aggressive Forms of Cancer

Marijuana contains at least 60 known chemicals called cannabinoids, which activate cannabinoid receptors in your body. Tetrahydrocannabinol, or THC, is the main component responsible for the psychoactive effects, or “high,” marijuana is known for. While THC is known to have some medicinal value, there has been recent investigation into a new cannabinoid that is rumored to have more medicinal benefits than any single pharmaceutical drug on the market.

What is Cannabidiol (CBD)?

This cannabinoid is known as Cannabidiol (CBD), and is the second most abundant cannabinoid in cannabis. Research done by G.W. Pharmaceuticals suggests that CBD could be used for treating symptoms of rheumatoid arthritis and other autoimmune diseases, diabetes, nausea, bowel disorders, and many other hard-to-control side effects. According to an article from Projectcbd.com, CBD has even demonstrated neuroprotective effects, and its anti-cancer potential is currently being explored.

While it was originally believed that THC is a breakdown product of CBD, it is now known that both THC and CBD are actually metabolites of their decarboxylated acidic forms, THCa and CBDa. These acidic precursors are decarboxylated (essentially dried) by heat or extraction to produce THC and CBD; only then do they become psychoactive. The compound has medicinal benefits without the “high” that some patients do not desire. This makes CBD appealing to patients who are looking for an alternative to their current meds, which often have opiate-like effects.

“After years of growers aiming to boost THC percentages in their crops, many growers have switched to focusing on producing CBD-rich strains because of the increasing demand by medical users.”

Cannabidiol is even known to counteract some of the effects of THC like the “munchies.” Just as THC increases our appetite, CBD suppresses it, which could be ideal for patients watching their figure. CBD just might be a key ingredient in a future weight loss drug, who knows? There is one exception to the theory that CBD suppresses appetite, but it is a blessing as well. Many people who have difficulty eating due to their stress or anxiety can use CBD to get rid of that sick feeling in their chest or stomach, allowing them to eat again once their anxiety subsides.

CBD Used To Treat a Number of Symptoms in Patients

Cannabidiol is what gives cannabis its’ sedative effect, and has been known to ease a number of symptoms from difficult conditions.  There has actually been a substantial amount of experiments done on cannabidiol that has proved its healing powers. Dr. Sean McAllister, a scientist from the Pacific Medical Center in San Francisco, made an astounding discovery about CBD. McAllister has been studying cannabinoid compounds for 10 years now in search of new therapeutic interventions for various cancers. He discovered that cannabidiol is a potent inhibitor of cancer cell proliferation, metastasis, and tumor growth. Results of his experiments on breast cancer show that the number of cancer cells diminished as more CBD was applied. Essentially, CBD may be a generally effective way to switch off the cancer-causing gene, providing patients with a non-toxic therapy to treat aggressive forms of cancer.

“CBD could be used for treating symptoms of rheumatoid arthritis and other autoimmune diseases, diabetes, nausea, bowel disorders, and many other hard-to-control side effects.”

Raphael Mechoulam of the Hebrew University, Jerusalem, and Faculty of Medicine has been studying cannabinoids for almost 50 years. Mechoulam gave a talk on cannabidiol on the 45^th year of involvement in the field in which he spoke about a number of experiments being done on cannabidiol. He described an experiment that was done in Brazil in which a 200mg/day dosage of CBD was added to the anticonvulsants epilepsy patients were currently taking. Over the course of several months only 1 of the 7 patients showed no improvement; three became seizure-free; one experienced only one or two seizures, and two experienced reduced severity and occurrence of seizures.

CBD Proven to Reduce Inflammation

A colleague of Mechoulam’s, Marc Feldman at Imperial College, London, tested CBD on mice that had a version of rheumatoid arthritis and found that it reduced inflammation by 50% at the right dosage. Cardiologists working with mice at the Hebrew University have found that a dosage of CBD immediately following a heart attack can reduce infarct size by about 66%. Probably one of the most notable studies conducted by Mechoulam was on mice bred to have a version of type-1 diabetes. The diabetes manifests around 14 weeks so the mice were treated for the first 7 weeks of their life, then again in another 7 weeks. He concluded that only 30% had developed diabetes compared to the 90-100% given the placebo. He then repeated the experiment where the CBD wasn’t introduced until 14 weeks when the diabetes first developed. They were then tested at 24 weeks of age and again only 30% of the treated mice were found to have diabetes.

“CBD did not just prevent onset, it blocked the development of diabetes.” - Mechoulam says.

Since CBD is a function of an increase in temperature, cannabis is heat activated in the testing process to get measurements. CBD typically shows up under, or around 1% in most strains. Since most strains have this low percentage it is sometimes hard to find a CBD-rich plant with low THC percentages as to avoid the ‘high’. However, that doesn’t mean that these CBD-rich strains don’t exist. “Cannatonic” is one known popular CBD-rich strain which is known to contain 6.5% CBD by weight, and the same amount of THC, making for one of the most medicinal strains out there. Harlequin, Jamaican Lion and Omrita Rx3 have been tested several times by several labs and are in the neighborhood of 8-9% CBD and 5.5-6% THC —about a 3:2 ratio.

We have only begun to scratch the surface of understanding this miraculous cannabinoid. While significant discoveries have been made about the medicinal benefits of Cannabidiol, there is much left to reveal about this cannabinoid. You can read about recent developments in ProjectCBD.org’sCBDiary, a catch-all column for news generated by patients, doctors, dispensaries, growers, plant breeders, pharmacologists, the industry, the government —all the players— as the CBD story unfolds.

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Which Drugs Actually Kill Americans

U.S. drug-related deaths, over time Katie Peek

In 2010, there were 80,000 drug and alcohol overdose deaths in the U.S., according to the Centers for Disease Control and Prevention's WONDER database. The database, maintained by the National Center for Health Statistics, keeps a tally of all the deaths listed on certificates nationwide. They’re classified by the ICD-10 medical coding reference system.

Death reporting in the U.S. requires an underlying cause—the event or disease that lead to the death. This chart represents all those listed in the CDC database as “accidental poisoning,” “intentional self-poisoning,” “assault by drugs,” and “poisoning with undetermined intent.” In addition to the underlying cause, a death certificate has space for up to 20 additional causes. That’s where “cocaine” or “antidepressants” would show up. The subcategories are limited in their detail—many drugs are lumped together, like MDMA and caffeine, which are listed together as “psychostimulants.” And about a quarter of all overdose death certificates don’t have the toxicity test results listed at all, landing them in the “unspecified” stripe.

By adding all those sub-categories up, imperfect as they may be, it’s clear that the rate of reported overdoses the U.S. more than doubled between 1999 and 2010. About half of those additional deaths are in the pharmaceuticals category, which the CDC has written about before. Nearly three-quarters of the pharmaceuticals deaths are opioid analgesics—prescription painkillers like OxyContin and Vicodin. And while cocaine, heroin and alcohol are all responsible for enough deaths to warrant their own stripes on the chart, many popular illegal drugs—including marijuana and LSD—are such a tiny blip as to be invisible.

A few caveats about the statistics: if a person had multiple drugs listed on their death certificate, they’re being counted twice here. Also, the database doesn’t include nonresidents—either undocumented immigrants or U.S. citizens living abroad.

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