With the recent news of our submission to the FDA of a New Drug Application for our lead pipeline candidate, GMRx2, we sat down with our CEO, Mark Mallon to learn what Mark’s first three months have been like leading the company, what the future looks like for George Medicines and why he describes himself as a ‘paranoid optimist’.
1) Tell us about your first 3 months at George Medicine
They have certainly been busy! I’ve been working closely with the team in London and had the chance, early on, to meet all the great folks at The George Institute for Global Health in Sydney. What this company has achieved so far has really exceeded my expectations. The common theme I’ve noticed is that everyone is passionate about the opportunity we have to make a difference for people with hypertension. There is a very clear mission here.
One of our priorities in recent weeks and months has been finalizing the New Drug Application (NDA) for GMRx2 to the US Food and Drug Administration, which takes us one step closer to bringing our candidate treatment for hypertension to patients. This has been a huge task, particularly for a small team, but we have delivered it, so I’m hugely excited about the progress we’re making.
Clearly another priority is identifying commercial partners who we can work with, around the globe, to bring this medicine to patients. Working with the right partners is key for us – companies who share our belief in the potential of GMRx2 and recognise that, working together, we have an opportunity to make a huge positive social impact. So those conversations are key at the moment.
2) Why did you join George Medicines?
Well, that’s pretty easy – I get the opportunity to lead a growing and dynamic company that has a real opportunity to make a difference in the field of hypertension management, and more.
I’ve been in the life science industry for over 30 years and, interestingly, throughout my career I’ve always had hypertensive treatments in the portfolio of products that I was responsible for. And it has been a constant source of disappointment for me that current treatments haven’t been used to their full effect. Despite those very effective treatments, high blood pressure continues to present a huge global health burden that has proven largely resistant to the treatments that have been introduced over the decades.
I’ve already been part of some great projects to improve that. For example, when I was at AstraZeneca, I had a chance to launch a programme called Healthy Heart Africa where we found a way to leverage existing infrastructure and clinics in a new way to reach more patients and improve hypertension diagnosis rates, which is obviously an important first step in getting patients the treatment they need. We dramatically increased the number of people who understood what their blood pressure was and got them to doctors to talk about what treatment they needed. So, it is possible to make a difference.
There are some very good medicines that can bring blood pressure down effectively, yet too many people still don’t have their blood pressure under control and that bothers me. When I learned about George Medicines and its lead program I wanted to be involved because it has the potential to be key to unlocking better treatment for patients with hypertension.
3) What skills and experiences from elsewhere in your career are particularly pertinent for your role at George Medicines?
I’ve been fortunate enough to be part of great teams – and to build great teams – who have achieved significant successes. During my career I’ve been involved in ten or more major new product launches, gaining a lot of experience along the way in shaping new medicines and really helping teams to think about what those new medicines can do and how they can deliver the most impact for patients who could benefit.
There are so many different stakeholders – regulators, physicians, distributors, payers – to bring with you, when you’re delivering a new medicine to patients. Our industry is a complex one and key to achieving success is ensuring alignment and maintaining energy and commitment to act. That’s a critical aspect of what I hope I can bring to the team.
One thing I’ve learned is you have to be ready to take on the difficulties, so I’m pretty resilient. I sometimes describe myself as a paranoid optimist – optimistic that we can achieve great things, but ready to recognise the challenges that we’ll face. You have to be relentless to make something difficult happen. I’ve been involved in several projects where we were definitely viewed as an underdog in what we were trying to do achieve. That didn’t stop us though!
I’m betting that all of these experiences will be useful as we continue to build George Medicines.
4) What has been a highlight at George Medicines so far?
Meeting the George Medicines team in London and the George Institute teams in London and Sydney have certainly been the highlights. The talent and dedication! People doing great scientific work, others with excellent business and industry skills.
It really has been about the people, and I would be remiss not to mention the great time I spent with Ingmar Wahlqvst, one of our Board members, in Melbourne, visiting Melbourne Cricket Ground and seeing my first Aussie Rules football game. That wasn’t work. But it was a lot of fun. It’s a beautiful place.
5) How do you envisage GMRx2 impacting the landscape of hypertension?
Well, in the simplest terms, we want it to get more people, significantly more people, to their blood pressure goal.
Hypertension is a big issue everywhere. It’s an issue in the US and Europe, but it’s a bigger issue in many other places around the world, including Africa and India. Even in countries with well-established health systems, only one in four people have their high blood pressure under control and that’s despite many good medicines being available. That’s why we have to do something different. Everybody who I’ve been interacting with believes that GMRx2 has the potential to make a difference, which is incredibly exciting.
This is more than just improving convenience for patients. Although certainly, combining three commonly used agents into one pill does that, and offers opportunities to make treatment more affordable, accessible and easier to use – which are all important.
The real benefit of GMRx2 is unlocking the potential for better treatment, because we know, and the international guidelines back this up, that most patients are going to need more than one drug to control their hypertension. But most don’t get the benefits of two or three medicines until late in the treatment pathway. It takes a while to get there and there are always concerns, rightly so, about bringing together multiple drugs at standard doses, because all drugs bring their individual side effects. So having a low dose combination product is a way to introduce patients, sooner in the process, to the benefits of a triple mechanism control of hypertension, combining efficacy with good tolerability.
The early promise of GMRx2 was shown during a pilot study called ‘TRIUMPH’, conducted by The George Institute in Sri Lanka. That study looked at the low dose approach of a triple combination agent, comparing it to the standard of care. It showed that a low dose, or half dose of the triple combination, was able to get 70% of patients to their target blood pressure control goal versus 50% for the people managed with standard of care, that’s a huge increase. That result guided our development of GMRx2.
6) What are you most excited about for the future of George Medicines?
Short term, I am most looking forward to getting GMRx2 approved in hypertension and delivering on our ambition to enable more people to gain control over their blood pressure. This is a challenging, high-risk industry and more often small companies fail rather than succeed. So, that first approved indication would be a major achievement for George Medicines. Our regulatory filing is obviously a significant step in the journey.
Beyond that, there are other indications where GMRx2 could make a difference, so we’re doing a lot of work now to map out the life cycle for the product, and I believe we have the potential to build a franchise – or a platform – from this single product. For example, there is an ongoing study called ‘TRIDENT’, being conducted by The George Institute, which is looking at the potential of GMRx2 to reduce the risk of recurrence of haemorrhagic stroke – a stroke caused by ruptured blood vessels in the brain. There are other opportunities to explore in cardiovascular disease and diabetes.
So, a bright future for the company, I hope, and lot for the team and me to be getting on with!