CHRIS TOVEY

Spain 2021 | HEALTH & EDUCATION | VIP INTERVIEW

TBY talks to Chris Tovey, Chief Operating Officer of GW Pharmaceuticals, about the Spanish market, investment in R&D, and the role of cannabinoids.

What is the mission and vision of GW pharmaceuticals over the past 20 years?

GW Pharmaceuticals (GW) is a global biopharmaceutical company that over the past 23 years has established a world-leading position in cannabinoid science and medicine. GW's mission is to unlock the potential of the cannabis plant through rigorous scientific investigations and extensive clinical trials to improve the lives of seriously ill patients. Founded over two decades ago in response to significant unmet patient need, patients remain our key focus and improving their quality of life, our motivation. GW's pioneering work has led to the regulatory approval of world first, potentially life improving, cannabis-based medicines. Our continued dedication to research and development in this field has resulted in the treatment of thousands of patients with our medicines. We have partnered with regulators, legislators, payors and the medical community to find a way forward for these novel medicines. By catalysing change within the current system, we have made our cannabis-based medicines more accessible and established a roadmap for a new area of medicine that others could follow.

What prompted the decision for GW to enter the Spanish market?

Formally establishing our presence in Spain underscores our long-term commitment to Spanish patients and physicians and furthers GW's mission to bring innovative cannabinoid medicines to patients with high unmet need. Spain continues to be one of Europe's best environments for research and clinical development and is an important hub for GW Pharmaceuticals. Multiple Spanish hospitals have participated in GW clinical trials and we're proud to currently be conducting significant levels clinical research with key health centres in Spain to investigate the potential for cannabinoid medicines in a range of rare disease areas.

How much does GW invest in R&D to keep discovering and promoting the benefits of cannabinoids?

Globally, GW has invested over EUR1.4 billion in research and development and the infrastructure needed to bring novel, innovative medicines to patients, and we employ over 1,000 people worldwide. Much of what is known about the medical uses of cannabis was discovered by GW – we have led the way in understanding cannabinoid science and how, if harnessed correctly, it has the potential to improve the lives of patients and their families. Consequently, we have initiated a robust pipeline for clinical development, pioneering significant advancements in the development of cannabis-based medicines. Through collaboration with world leading specialists, institutions and research organisations, we will continue to invest heavily in the research needed to accelerate the development of medicines that address serious unmet medical needs and could help thousands more patients. As a world leader, we understand that we have an important role to play in informing and shaping the external environment to realise the full medical potential of the cannabis plant, while considering patient safety and the protection of public health. We take this responsibility very seriously.

What are the main applications of cannabinoids?

Cannabinoids are a broad group of three types of molecules (phytocannabinoids, endocannabinoids and synthetic cannabinoids) that have an effect on or are related to the endocannabinoid system – a system in the human body that regulates many different physiological processes. Plant cannabinoids (phytocannabinoids) are unique to the cannabis plant and more than 100 have been identified. The two best understood plant cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC) – both are known to have medical benefits, but for most potential indications, further research is needed to establish their efficacy and safety. Despite the pioneering work by GW to unlock the medical benefit of cannabis through rigorous scientific investigations and extensive clinical trials, there is still much we don't know about its true potential and the impact of CBD and THC on the human body, including potential side effects. We also know from our research that the cannabis plant contains a number of other phytocannabinoids and compounds that are or could be pharmacologically active at different levels and that need to be properly investigated for both their positive effects as well as their side effects. GW believes passionately in the potential therapeutic benefits of the cannabis plant and firmly believes that cannabis-based medicines have potential to improve the lives of patients and families. Over the past two decades we have established extensive experience in researching, developing and delivering novel, breakthrough medicines. By applying scientific and medical rigour to our understanding of the cannabis plant, we have already been able to bring two potentially life improving cannabis-based medicines to patients. Currently, we understand the evidence for the potential use of one of our medicines in certain types of rare epilepsy/seizure syndromes and another in spasticity associated with multiple sclerosis (MS).

The medical cannabis sector is growing at pace among investors. What has GW's strategy been for attracting investment in such a new and unique industry?

Over the past 23 years, GW has played a significant role in raising the profile of and shaping the medical side of the cannabis sector that we see today. We have individually established a new market segment by proving that complex botanically-extracted cannabis-based medicines, whether complex or 'single' cannabinoid in composition, can be successfully routed through the established pharmaceutical regulatory approval pathway in the same way that all other medicines are. This dedication to research and development has broken new ground (unlike other cannabis-based products, our medicines have known and accepted safety, quality and efficacy profiles independently assessed by medicines regulators) and made GW's offer unique and therefore market leading within this field. Consequently, our positioning as a patient-centric and science-led pharmaceutical company undertaking pioneering work to unlock the medical benefit of the cannabis plant has attracted long term investors to GW, drawn to our scientific and medical credibility, focus on unmet patient need in rare diseases and successful generation of high-quality data and evidence. We are proud to have paved the way for others to follow and now develop medicines via the established pharmaceutical regulatory approval pathway, and we encourage other companies to follow our lead in the best interests of patients. The more substantial, high quality evidence that can be gathered before subsequent assessment via the existing regulatory route, the better for patients and clinicians.

What are your key priorities for 2021?

Our immediate priority in Spain is to collaborate as closely and swiftly as possible with relevant Spanish agencies to ensure access to our medicines for the patients and clinicians who urgently need them. Looking to the future, GW remains committed to leveraging our deep scientific knowledge, regulatory know how and extensive body of research in cannabinoid science to treat other diseases where our medicines could help address significant unmet need. These include autism, spasticity associated with spinal cord injury (SCI), neonatal hypoxic-ischemic encephalopathy (NHIE) and schizophrenia. Given our experience and leadership, we also feel it is our duty to educate on our findings and experience to promote better understanding of this emerging area of medicine and ensure accurate and evidenced based discourse on science.