Carlsbad company pursuing FDA approval for cannabis based treatment
BY CAROLINA ALBAN-STOUGHTON
June 27 is a date on everyone’s mind at Greenwich Biosciences. As that day gets closer, the anticipation is palpable at the company’s Carlsbad headquarters. Back in October, the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epidiolex®. This cannabis plant-derived medicine is meant to treat two types of highly treatment-resistant conditions of childhood-onset epilepsy: Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome. “This would represent the first plant-derived cannabinoid ever approved by the FDA. There are some drugs, some cannabinoid based medicines on the market now, but they are synthetically derived products,” said Stephen Schultz, Vice President of Investor Relations at UK-based GW Pharmaceuticals, the parent company of Greenwich Biosciences. Epidiolex®, a cannabidiol or CBD, received Priority Review status by the FDA, an accelerated review period that was granted to the company because of the outstanding unmet need in treatment for patients with LGS and Dravet Syndrome. “This would be the first pure CBD medicine, so it’s kind of a first-in-class, which is very exciting. We are leading the way here,” said Schultz.
While just the fact that the FDA granted Epidiolex® Priority Review is a positive sign that the medicine could hit the market soon, the review process is extremely thorough. “They’re actually looking at the safety, the efficacy of the drug,” said Schultz, “your manufacturing facilities have to all be inspected and pass a very rigorous FDA inspection.” The review would continue with an advisory committee meeting the FDA hosts, attended by a panel of doctors who discuss the application and the medicine. This event is also open to the public, who can listen to answers to the broad variety of questions that will certainly be asked. “We are the guest of honor. It’s an event that the company spends a huge amount of energy preparing for. It’s going to be some time probably in the second quarter this year. It’s generally a single day meeting and this is, as I mentioned before, a first in class medicine. They’re probably interested in understanding all the facets of what this product has to offer. So that will be a big event for us,” said Schultz not hiding his excitement.
Looking for approval
Should the medicine get approval from the FDA and before it can be sold, the Drug Enforcement Administration (DEA) needs to reschedule the medicine, which they have, by law up to 90 days to do. “In the new drug application there’s an abuse liability analysis that we are required to submit. And that abuse analysis uses different comparators. It’s designed to determine how likely to be abused your medicine is compared to those comparators. So we’ve submitted that analysis and the analysis shows that our CBD product is less likely to be abused than the comparators that we use, which were Schedule 3, Schedule 4 and Schedule 2 drugs. So what happens is, technically the FDA will make a recommendation – based on that abuse liability analysis – to the DEA.” Once the DEA reschedules the medicine Greenwich Biosciences would be able to distribute Epidiolex® by the end of this year.
According to Schultz, the approval of this medicine would be a significant game-changer for the industry and the patients. “I think this is very meaningful. An approval of the first cannabinoid based medicine I think is an important event for the FDA and certainly for those companies that are working in this environment. It’s challenging to develop a medicine from cannabis. It’s easy to grow plants. It’s very challenging to create an FDA approved medicine from those plants. And that is our core competency.”
A different route
As with anything new, Schultz is very aware that part of this whole process is educating the community on exactly what they are doing, especially with the rise of several types of medical marijuana that are currently being prescribed.
“I think some of the pro-marijuana groups see us as maybe trying to hurt their business. That’s not the case at all. We really don’t even operate in that environment.” Schultz said. “Our goal is to create an additional option for these patients and for the physicians to prescribe medicine that happens to be from the cannabis plant. We believe that the proper route is through the FDA process, because that process is one that yields a level of confidence from both physicians and patients that you know what the medicine is. For you to have confidence in a medicine you have to know that the medicine is exactly the same every time you get it; that the medicine has cleared dosing instructions based on clinical evaluation, clinical experience; that the medicine is fully characterized for its safety and its efficacy – so you know what it does and what it doesn’t do. We’re not trying to block anyone’s ability to operate. We think ultimately the decision on what medicine you use is between the physician and the patient.” If approved, Epidiolex® could potentially be covered by insurance, helping patients get treatment without the high cost of some types of medical marijuana. Epidiolex® doesn’t have the psychotropic effects of THC (Tetrahydrocannabinol), which is found, sometimes in high levels, in many cannabis products.
An environment for growth
While the waiting continues, Greenwich Biosciences is moving rapidly to expand their operations, and recruitment plans are underway. According to Schultz, this shouldn’t be a difficult task as he strongly believes bringing the company to Carlsbad is a huge plus. “Look out the window. What a lovely place to be in. But I think it goes deeper than that. This sort of Carlsbad and Southern California area is a hub of biotechnology innovation. And I think one of the key objectives when we were looking for the US Headquarters was to find a location that was sort of biotech centric. You can see how many people we are hiring – granted not all of them are coming from Southern California- but we wanted to make sure that we were located in an area where we could access top talent.”
When searching for top talent, the company is looking not only for people with the right skills, but also for employees who are in tune with the company’s larger mission. “We have a job to do and we do it. But going to work knowing that you are helping humans, especially these young children that have such a difficult life because of this seizure activity that they can’t control, it’s a beautiful thing. The employees of this company go to work with those patients in mind everyday. That’s why we exist. And it’s an honor and a blessing to go to work with that objective in mind.”
For more information about Greenwich Biosciences, and their products, please visit: www.greenwichbiosciences.com