On 1 November, cannabis-based epilepsy treatment Epidiolex went on sale throughout the US, having become the first drug incorporating non-synthetic cannabidiol to win FDA approval over the summer. In our latest in-house Q&A, PLN caught up with Epidiolex manufacturer GW Pharmaceutical’s general counsel Iain Ward.
London-based GW has spent 20 years researching and commercialising cannabis-derived medicines, notably multiple sclerosis treatment Sativex, which currently holds marketing authorisations in 21 European countries and is slated for a phase 3 trial in the US.
The launch of Epidiolex in the US follows an underwritten public offering of GW on the Nasdaq, with counsel from Mayer Brown, which raised US$345 million at the beginning of October. The drug is also being considered for orphan drug status by the European Medicines Agency.
PLN spoke to Ward shortly after the deal closed to find out his view on the regulatory climate for cannabis products on both sides of the pond and the lawyers he turns to for guidance.
What route did you take to becoming an in-house lawyer at GW?
I came to this job via a route that wasn’t really planned. I trained as a corporate/commercial lawyer at Ashurst then took roles of increasing seniority at AstraZeneca, Covington & Burling, GE Healthcare, Shire, Consort Medical and the Wellcome Trust.
What attracted you to the life sciences industry?
All my family were/are healthcare providers. Apart from giving me something to say over the dinner table, there is something about the directness of impact that you might have on patients’ and carers’ lives [as part of a drug company] that can get me racing through the shower to get to work.
What particular challenges face in-house counsel at cannabis-based companies?
There is still a significant stigma surrounding the cannabis sector, which is fascinating from a social perspective, but is also a real driver to generate robust evidence to help effect change. There are a number of companies focusing on the large-scale production of CBD and other cannabis-derived products and who perhaps haven’t spent the time and money that GW has on investing in evidence of efficacy or safety or a fully FDA-approved growing and manufacturing process. Policing such companies in a fair way that permits growth in the sector but holds them to the same standard we work to is a challenge. Fast-paced growth always brings its challenges too, with all of our office space around the world running out almost constantly!
What does the UK government’s recent move to legalise the prescription of cannabis-based medications mean for the industry, and your company in particular?
The focus of the government’s reforms is very much on encouraging further research and clinical trials into cannabinoid science and medicines, which is something GW wholeheartedly supports and believes is in the interests of patients and physicians; we have been doing such work with great success for the last 20 years.
Patient access to cannabis-based medicines will undoubtedly increase somewhat as a result of the reforms, but the decision to prescribe has rightly been placed in the hands of specialist clinicians who are likely to be cautious about freely prescribing “investigational medicines”, which entail a clear risk and lack the reassurance around quality, safety and efficacy that regulatory approved medicines provide. GW continues to believe that the best way to help seriously ill patients and their families is through developing regulatory approved medicines, which has resulted in our recent FDA approval and ongoing EMA submission for our cannabidiol oral solution (CBD) and the existing MHRA and wider approval of our product for use in spasticity in MS, Sativex
How has the UK regulatory environment for cannabis-based medicine traditionally compared to the US? How does the latest change alter this situation?
The latest position from the UK government undoubtedly helps to diminish the stigma associated with the usage of cannabis-derived products and encourages further research in the area. Of course, the position in the US has for a while been that several states have legalised the recreational use of cannabis and while this more permissive stance has reduced the stigma, there are still significant controls around the supply and usage of cannabis-derived products. Epidiolex, recently approved in the US (though not yet in the EU) remains a controlled drug, albeit now within the less restrictive schedule V, which recognises the drug’s low potential for abuse and its ability to have a medicinal effect. We don’t yet know what this means for the scheduling of the same drug across EU member states.
What does your department do differently to other life sciences legal teams? What mistakes do you try to avoid?
We are still small and so we can still afford to communicate constantly but being split between the UK and the West Coast of the US can mean long days on both sides of the Atlantic. We prioritise facetime with each other; it doesn’t eliminate mistakes altogether, but it does help us to foster relationships based on trust and respect. Nobody wants to make mistakes but they inevitably happen and the important thing for me is to create an atmosphere where mistakes are approached with kindness and an overriding imperative to learn from them.
What issues are currently keeping you busy? Are they specific to GW, or characteristic of the sector as a whole?
Apart from the heavy press coverage surrounding the government’s new position, we have just closed out a new financing round for GW, raising US$345 million, which has made the last few weeks particularly intense given the volatility of the markets and the uncertainty surrounding Brexit. We are also building a fully functioning sales force from scratch in the US and the EU, which feels like quite a big deal for what has historically been largely an R&D dominated company.
When do you turn to external law firms, and what do you look for when retaining them?
We have quite a heavy regulatory/government affairs overlay to what we do, so in addition to the corporate advice we go to Mayer Brown or Slaughter and May for, we also use Covington extensively to navigate the somewhat more uncharted regulatory waters. For me, directness and clarity are the two most important characteristics.
What development or achievement do you take the most pride in from your tenure at GW?
Most obviously, it was great to be involved in the recent financing so soon after joining and although I haven’t had time for much else, of immediate importance to those around me has been the ability to get an agreement for more office space in our rapidly expanding London office. When the global head of research is walking around looking for a chair or a shelf to perch on, you know it could be time to acquire more space!