GW Pharmaceuticals is the company that has legitimized medical cannabis in the eyes of the world's major regulatory authorities. Founded in Cambridge in 1998 by two British doctors, it is behind the only two cannabis-derived medicines to have obtained full regulatory approval, first in Europe, then from the US FDA. Its story is one of scientific conviction held together over more than twenty years, against all odds, culminating in a $7.2 billion acquisition.
Geoffrey Guy is a British physician and pharmacologist, born in 1954. In the 1980s, he worked for Laboratoires Pierre Fabre in France, specializing in botanical medicines. It was there that he began to wonder about the therapeutic potential of cannabis: a plant with thousands of years of documented medical use, abandoned by modern medicine for political rather than economic reasons.
scientific.
In 1998, he read a book by an American nurse, Mary Lynn Mathre, advocating the medical use of cannabis. For Guy, it was confirmation. He contacted Brian Whittle, another entrepreneurial doctor in the British biotech sector, and the two went straight to the Home Office to present their project. Guy warned officials that he would need to grow «tons and tons» of cannabis, not just a few plants. Intrigued, the officials ask for a full development plan. Five months of legal work later, GW Pharmaceuticals is founded with the necessary licenses.
In 1998, GW obtained its cultivation license from the Home Office and the MHRA. The first plants are grown in a secret air-conditioned greenhouse in southern England. The same year, GW signed an exclusive agreement with HortaPharm B.V., a Dutch cannabinoid research company founded by the American David Watson (aka «Skunkman Sam»), which gave GW access to its entire varietal collection, dozens of genetics selected for their precise cannabinoid profiles.
Clinical trials began in 1999. Guy and Whittle took a scientific gamble against the grain: all the world's research was focused on THC, but they were interested in THC/CBD ratios. Studying cannabis-based medicines from the 19th and 20th centuries, Guy found that they contained around 50% of CBD and 50% of THC. This historical insight guides all GW R&D. A researcher at a New York conference in 1998 claimed that CBD was an inert component of cannabis, Guy is convinced otherwise.
GW's first product, the Sativex, is a mouth spray with roughly equal doses of THC and CBD. It has been developed to treat spasticity associated with multiple sclerosis. In June 2010, Sativex became the first cannabis-derived medicine to gain marketing authorization in the UK, the first full regulatory approval of a cannabis medicine in the world since the 1930s.
It was subsequently approved in around twenty European countries: Spain, Germany, Denmark, Czech Republic, Sweden... In 2011, GW transfers marketing rights in Asia, Africa and the Middle East to Novartis (Switzerland). In Canada, Sativex is approved for neuropathic pain and spasticity associated with multiple sclerosis, as well as for certain types of cancer pain. In France, the proposed reimbursement rate did not suit GW Pharmaceuticals, so Sativex was never marketed.
GW went public on London's AIM in 2001, with shares priced at £1.82. The stock remained stable for a decade, despite clinical successes. It was the transfer to NASDAQ in 2013, and the American biotech craze, that transformed the company's stock market trajectory. GW will delist from AIM in 2016, retaining only its US listing.
GW's second big bet concerns pure CBD to treat severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, two pathologies resistant to all existing treatments.
Phase 3 clinical trials begin in 2015. In August of the same year, the FDA grants Epidiolex Fast Track status. In June 2018, the’Epidiolex becomes the first cannabis-derived medicine to win FDA approval, a landmark validation that enshrines medical cannabis as «serious science» in the words of CEO Justin Gover. The European Union approves Epidiolex in 2019 under the name Epidyolex.
Commercial launch in the US in November 2018 propels GW revenues from $15 million in 2018 to $312 million in 2019. Clinical data show 47% of treated patients see at least 50% reduction in seizures after 12 weeks.
In France, Epidiolex is only available under Autorisation Temporaire d'Utilisation (ATU). In 2019, GW's two drugs will enter the UK National Health Service.
In January 2021, Irish group Jazz Pharmaceuticals announces the acquisition of GW Pharmaceuticals for $7.2 billion, the largest-ever acquisition in the medical cannabis sector. The deal is expected to close in May 2021. Geoffrey Guy, who started the company with his personal chequebook and a Home Office license, steps down as Chairman.
GW Pharmaceuticals is now a subsidiary of Jazz Pharmaceuticals, which continues to develop and market Sativex and Epidiolex worldwide. The company has invested over £1.3 billion in R&D throughout its independent existence, and produces around 100 tonnes of medical cannabis a year.
Without GW Pharmaceuticals , and without Geoffrey Guy , there would probably not have been a global CBD revolution: it was GW's research that demonstrated, for the first time within a rigorous regulatory framework, that CBD was not an inert component of cannabis, but a therapeutic molecule in its own right.
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