The company’s success is largely built on their lead candidate filgotinib, a small molecule drug for inflammatory diseases like rheumatoid arthritis (RA) and Crohn’s disease. We wanted to know what’s in store for Galapagos, and what van de Stolpe’s personal thoughts and predictions are for the Belgian biotech ecosystem in the coming years.
Let’s start with your company: what’s in store for Galapagos in the near future?
The approval for filgotinib is of course the most important thing for us this year. After 21 years, we are finally bringing a drug to the market. It’s such a big deal that I think it will even boost Belgium’s image as a biotech country.
We’re expecting that filgotinib’s approval for RA will rapidly be followed by other indications, like ulcerative colitis. But we also have so much more in the pipeline. We have a lot of Phase II readouts this year (5 planned), including for drugs in osteoarthritis or IPF [idiopathic pulmonary fibrosis]. We’re doing over 80 clinical trials this year, which is massive.
What are you personally most excited for?
There’s always a new thing to get excited about at Galapagos, but personally I am looking forward to seeing the results of a particular project that is coming to fruition this year. It’s a new mechanism that we found through our target discovery platform. We’ve code-named it Toledo.
“If Toledo is successful, it will work even better than current drugs… This is the biggest pharma market in the world, and we might have a new mechanism that turns everything upside down.”
Toledo is really a once-in-a-lifetime opportunity. There are some academic articles about the mechanism, but pharma hasn’t really picked up on it. We have invested massively in research over the past couple of years and the project is now ready to move into the clinic (we’ll start our first Phase II studies this year).
If Toledo is successful (and we’re all convinced that it will be), it will work even better than current drugs like the JAK inhibitors or the TNFs. This is the biggest pharma market in the world, and we might have a new mechanism that turns everything upside down. That is so exhilarating.
Do you think that biotech companies are particularly well-positioned to pursue these kinds of cutting-edge discoveries?
Yes, and I’m a strong believer in harboring that innovation in biotech. I can’t think of a single good example where a biotech was bought by a pharma company and continued innovating as it did before. We really have to cherish that culture and make sure that it is protected.
It’s why I’ve made it my life’s work to make sure that Galapagos remains independent. We’ve ended up with a beautiful deal with Gilead, where we get the best of both worlds. It’s a simple, beautiful arrangement that is far better than an acquisition.
Read this previous BioVox article for more on the Galapagos-Gilead deal.
Do you think the Galapagos success story has had a big impact on the Belgian biotech ecosystem?
Yes, I think you need companies like ours to show the way, for other CEOs, as well as for investors, banks, and the general public. The publicity Galapagos has generated helps to create awareness for the whole sector, but also pride in Belgium specifically. People start to invest more in local companies and Belgian students choose to study life sciences; it’s all part of the ecosystem. And you need every single part of it: the education; the financial side; the political support (where Flanders is particularly strong); and the role models like Galapagos, to lead the way.
“For the first time you see this whole class of European biotechs competing on the world stage. I think that will be an inspiration for others to come.”
Do you think we’re seeing more role models in Europe in general as well?
I definitely think that, with Galapagos, argenx and Genmab, we finally have three major biotech companies in Europe. Interestingly, two in Belgium. There’s also Evotec, which is very ambitious, and Morphosys which is up-and-coming. So, for the first time you see this whole class of European biotechs competing on the world stage. I think that will be an inspiration for others to come.
What are your predictions for Belgian biotech in the coming years?
I think one of the most important things will be finding ways to broaden the number of genes we can mine for novel starting points. With the regular druggable gene classes, you’re limited to about 8000 different human genes; the rest are just not accessible with small molecules.
New technologies are becoming available to address these non-druggable genes; RNA oligos, for example, and modified chemical molecules. I think types of new technologies will be vital.
So, you think new technological platforms will be key. What about the types of indications that companies are pursuing?
Clearly, orphan diseases will remain attractive to small biotechs. The commercialization, registration and development of orphan drugs are all easier. However, the pricing issue is a contentious point that is unlikely to go away. Society is just not ready for treatment costs in the hundreds or thousands of dollars. And the price of orphan drugs often ends up in that range, because otherwise you can’t recoup the cost of development and make the profit that your investors are expecting.
Read this previous BioVox article for more on drug development trends.
Drug development costs are already unsustainable; do you think they are going to get worse?
Everybody is making a lot of money in the process of drug development: the hospitals, the doctors, the CROs. And the companies are willing to pay because, from a competitive point of view, speed is of the essence. If you’re developing a treatment for a disease that’s going to sell for a billion dollars a year, then every day lost is worth 10 million. It’s simple, and it means nobody is particularly incentivized to reduce development costs.
The result is, of course, that drug development has indeed become unsustainable. Will it get worse? I don’t have the answer to that. I do have an idea for improving things though: bring the drugs to the market earlier. That could work, but you would need regulators that are open to passing a bill granting patients access to drugs with less safety data.
One way or another, something has to give.
What would your advice be to CEOs of other biotech companies? Your take-home message?
“My advice is: make sure you have a parallel path. The technology you’ve developed is a means to an end, and the end is getting the drug to the patient.”
Biotech entrepreneurs often center their companies around a technology platform, and then do some service activities to generate revenue and please their investors. That is all good, but if you don’t develop your own work, you will not create value in the long run. My advice is: make sure you have a parallel path. The technology you’ve developed is a means to an end, and the end is getting the drug to the patient.
It is more difficult here than in the US: the risk awareness is so much higher in Europe, and investors want to see low burn rates. The pressure is on for the management teams to generate revenues, and not necessarily to embark on a 15-year path of development.
As a CEO, you should have a dream. Follow your dream and hold on to your plan, without letting other people (like the VCs or your board of directors) influence where you’re heading. You’ll need a bit of luck, of course, but if you don’t have the ambition then you’re not going to get it. You’ve got to earn your luck.
You need to set the bar high and don’t settle for anything less than success.
This interview has been edited and condensed for clarity. Header image: Onno van de Stolpe (© Trends).