I think Forbes said it best in Debra Borchardt’s recent article, “GW Pharmaceutical Gets Closer To Forcing FDA On Cannabis,” with an announcement a couple of weeks ago that its Clinical Phase 3 trial results for Epidolex were positive in paving the way for FDA approval and tipping over the de-scheduling apple cart.
Whether it materializes in an immediate change or not remains to be seen. The prohibitionists surely have more dirty tricks up their sleeves and will continue to rear their ugly heads every step of the way until the FDA formally takes over the regulatory oversight of medical marijuana for over- and under-the-counter cannabis products in the United States.
Since we first included GW Pharmaceuticals (GWP) on the original CBE 10 Most Important Companies list (#5), we have spoken to many industry players about the inevitable final play for medical marijuana in the U.S. Realistically, we all know that the push for legalizing and regulating “medical marijuana” on a state level has been successful in moving the public opinion meter among Democrats and Republican law makers, and has played well in the battle to end Federal prohibition. At the end of the day, despite all of the anecdotal evidence, “medical marijuana” is not medicine according to the Food and Drug Administration (FDA) until it completes a long, arduous, and expensive process to receive approval as a medicine for use by humans. This process can take up to 10 years per drug application.
When you look at what the cannabis pharmaceutical business that GWP has been building since its inception in 1998, you have to consider the risk and magnitude of the investment that its investors and shareholders made without a guarantee of return. The process includes many steps for New Chemical Entity (NCE) development that includes several steps outlined by Wikipedia below, including:
In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.
They further examine the product for suitability to package as capsules, tablets, aerosols, intramuscular injectables, subcutaneous injectables, or intravenous formulations.
Only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug.
Clinical trials involve three or four steps:
Most NCEs fail during drug development, either because they have unacceptable toxicity or because they simply do not have the intended effect on the targeted disease as shown in clinical trials.
One study assessed both capitalized and out-of-pocket costs as about US$1.8 billion and $870 million, respectively
A study conducted by the Tufts Center for the Study of Drug Development covering the 1980’s and 1990’s found that only 21.5 percent of drugs that started Phase I trials were eventually approved for marketing. Between 2006 to 2015, the success rate was 9.6 percent.
With all of this in mind, GWP which is based in Salisbury, United Kingdom, is the first company in the world to develop a prescription drug that is the first natural cannabis plant derivative to gain market approval in any country. GWP’s first product, Sativex®, is now approved in 28 countries for the treatment of multiple sclerosis spasticity.
According to GWP’s 2015 annual report, they describe several accomplishments after investing nearly a billion dollars since inception.
With the successful completion of the Phase 3 Trial for Epidolex®, a new cannabidiol-based drug used to treat children with Dravet syndrome and Lennox-Gastaut syndrome (“LGS”) a rare form of childhood epilepsy, GWP’s next move for Epidolex is to gain approval from the FDA. It expects to submit a new drug application with the FDA in the first half of 2017. If approved, it would be a first—a plant-derived cannabinoid drug in the U.S. that hopefully forces the de-scheduling and removal of cannabis from the list of Control Substances.
There are several more new drugs in the pipeline for GWP in the U.S., below are some of the studies in progress.
With so much at stake, CBE would be remiss in not following GWP and CEO Justin Gover, who recently relocated to the West Coast. One thing is for sure: GWP is in the middle of the bulls-eye for cannabis investors.
Rob Meagher, CBE’s Founder, President and Editor-in-Chief is a 30 year veteran of the media world. His career has spanned from stints representing the Washington Post, USA Weekend, Reader’s Digest, Financial World & Corporate Finance to the technology world where he worked at International Data Group and Ziff Davis where he was part of the launch team for The Web Magazine, Yahoo Internet Life, Smart Business and Expedia Travels before starting his own marketing and Publisher’s Representative Firm. He also ran all print and online media sales and marketing for the Society for Human Resource Management before partnering with Forbes and then Fortune to create Special Sections covering a variety of topics. Rob, who started CBE Press in 2014, can be contacted at [email protected]
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