In September, Fort Worth-based pharmaceutical company Galderma was granted Food and Drug Administration approval for Mirvaso, the only topical drug approved to treat [the facial redness of] rosacea. The drug is expected to generate as much as $100 million in revenue for the company, which also produces Cetaphil, a popular over-the-counter skin care line.
We sat down with Galderma USA president Francois Fournier to discuss the product, and Galderma’s future.
In broad terms, what does Galderma do?
It’s a very unique company because we specialize only in dermatology. It’s only about the patients with skin conditions. The inception of the company was about 30 years ago, which in the pharma world is pretty new. We have two big shareholders—L’Oreal and Nestle—which means that we have real support in the long-term vision.
We are one of the few companies which is really controlling its destiny from the beginning ’til the end—we do the research, we do the development of our drug, most of our products are produced by us, we have our own plant. We have affiliates across the world in 65 countries, including Japan, which is rare in pharma, when you are not a Japanese company.
How is the dermatology market evolving?
The skin is visible, it’s open, and it’s the largest organ. And the patient, the physician, they are becoming more and more aware of that. The patient is becoming more and more informed—they have access to information, they are aware of disease, and they want to get treatment that they can buy themselves if they go over the counter at the retailer, at the pharmacy.
The population is also aging and people like us want to stay young, very young. You are very young but one day you will question yourself about how can I stay young as I’m older. And not only for the face. For example, people are more and more paying attention to their hands and how their hands look because you can look very young with treatment on the face, but your hands might betray you.
What does Mirvaso do and how does that play into this evolution?
Mirvaso helps rosacea, which is and which was so far a major issue for the patient, and where there was no solution. There are 45 million people across the world with rosacea—16 million in the U.S. For people with rosacea, it’s a real issue.
So far we were able to treat inflammation and we have a product for that—Oracea. But the erythema [Ed: redness of the skin] was not treated and the physicians were using lasers or they were using treatments that they know were not working. Now Mirvaso is a vasoconstrictor and it’s the only product I think really that you can see the effect.
My friend, she’s totally scared of meetings. This evolved because she has severe erythema. Brilliant mind working for a big company in the U.S., but at the end of the day when she has to give a presentation she’s more stressed by her appearance and how she looks than the presentation itself.
That tells you a lot—it’s a major issue. It’s a major issue which means it’s real innovation.
What was the development process like?
It was a classical development process like any other: phase one, phase two, phase three. We did not only assess the safety and efficiency of the product—which is of course what we have to do. But also there was a patient assessment and doctor assessment—doctor assessment is something for every drug, and doctors will say, “I’m happy with that result, I’m not happy with that result.” That’s the doctor assessment. But at the same time we decided, in collaboration, with the FDA, to ask for the patient assessment. To some extent that was extremely ambitious because the doctors can say, “Yes, I believe your erythema is much better through the product,” and the patient might say, “I’m sorry, but I don’t feel like that.”
For a patient, you wake up in the morning you apply the cream, thirty minutes later you don’t have erythema anymore, and it lasts for 12 hours. Which means for the patient and for the doctors they understand that first they will see a quick effect. And they go to work and they don’t have a problem.
So you have to apply this every morning?
Yes, it’s once a day. You apply on the area, and if you don’t apply well and don’t apply everywhere on the erythema, then the patient might have places where it will stay red and the other parts will be white.
This really does seem like it’ll change the market—not just Galderma, but the market for the public—for the better.
I think it’s important for me to reinforce that 16 million people have rosacea in the U.S. It’s an inflammatory and vascular disease. It’s a chronic disease. And most of them have erythema and this product will bring a solution. There is a big market, they have a lot of patients suffering. Before this product, there was no product working.
As a company, did you recognize that market gap and decide to approach it, or were you researching and doing things first and then discover that gap?
It’s a good question. I think because we are a specialized company in dermatology we have, I would say, a fair knowledge of the skin conditions and a good knowledge of what doctors and patients are expecting. We’ve been working for years on the different skin conditions and we know what the physicians and patients are expecting and it was really, “Where is the gap? What should be the solution, and do we have it?”
How long did you spend developing Mirvaso?
It was a classical development program. We started the development in 2008 and we did the submission at end of last year, in October. The product was approved at the end of August, and it will be followed by many other countries across the world in the next months.
That’s a fairly quick FDA approval process.
It was, yes. And something that was exceptional there was no what we call post-approval commitment. The FDA, rightfully so, will give the approval to a product and they will say everything is fine but we are still asking you to conduct a study. They want you to assess the product–which is absolutely fine.
This product was without any post approval commitment. Why? Because they considered it to be extremely solid.
How soon do you expect it to be on the market?
It is already today. If you know somebody with erythema, you can tell him or her to go to the physician, and the product is available.
It’s also part of our commitment that when we get a product approved we try to bring it as quick as possible. If you would ask dermatologists and pharmacists, they would say that Galderma is very impressive because the day you get the approval and the day the product is on the market is a maximum three weeks, which is exceptional, because you have to produce, you have to ship. When we get a product approved we have patients days after already looking for the product. You cannot disappoint them; you have to bring the product as quick as possible.
Once they hear about it, they want to have it.
Again we are in dermatology for skin conditions, which by definition are visible. When you bring a new product for hypertension, the patient…he doesn’t know if he’s the one that can get that treatment. He does not know if there are existing products…he does not connect the dots. Just the physician connects the dots.
When we speak about skin conditions, something which is visible and say, “Guys, you have erythema, there is no solution.” You have the people, they call us, they send email, they go to the doctor, because they connect the dots.
That is the reason why for us, it is important to bring the product as quick as possible.
What sort of financial impact do you hope it’ll have for your company?
The first priority is the patient. We are a company very much driven by, “Okay, what are our patients expectations?” What does he want, what does he need, and partnering with the physician to bring solutions to the patient. That’s the first thing.
The financial part is to have the capability to reinvest part of our revenue in research and development. That is the only thing which is driving us. We invest 20 percent of our global revenues into research and development. Which means, yes, I need to do business because the business of today will help me to finance the research and development of today for product tomorrow. Which means the financial impact is to be able to reinvest 20 percent of our global revenues for future product and for research and development. That’s the thing which is driving us.
What are you working on now?
We are for example, working on more very interesting products in rosacea—another product to come—which will be for the other problem of rosacea: pustules. We are finalizing the development of this drug. That’s for rosacea, which means that rosacea patients are really, really well treated with Galderma products.
We have also two compounds for acne. Because acne, let’s not forget one thing—it’s the most important skin condition in the world. And we have also compounds for acute dermatitis. And we have the compounds in impetigo, which is a skin infection especially for the young population. Acne, dermatitis, psoriasis, impetigo, and rosacea: those are really the areas where we are having a number of projects to come in the U.S. and also outside the U.S.