Mirvaso to be a $100 million drug for Galderma

A revealing interview with the Galderma USA President Francois Fournier has just been published by the Dallas Fort Worth Healthcare Daily.

This publication, `D HEALTHCARE Daily’ takes a keen interest in Galderma as the company’s US headquarters are in Forth Worth, TX.

mirvasao-cream

In the interview Fournier gives some interesting insights into the research and development of Mirvaso and also the hopes the Galderma holds for this newly FDA approved product.

Conversation With: Galderma USA President Francois Fournier

10/9/2013 by Bradford Pearson

In September, Fort Worth-based pharmaceutical company Galderma was granted Food and Drug Administration approval for Mirvaso, the only topical drug approved to treat 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.

It isn’t clear who actually made the $100m sales prediction. It doesn’t appear that Fournier stated this figure, so we are left wondering who made this projection.

It is certainly an impressive prediction, to go from zero to $100m for a new product. Also note, though, that there is no time scale associated with this prediction.

By comparison, we know that Oracea Capsules likely had annual U.S sales of approximately $319 m for the twelve months ending March, 2013 (see Oracea sales $319m y/e March 2013)

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.”

This explains a particular Phase III clinical trial that was hard to make sense of. Galderma wants the users of Mirvaso to be as convinced as their doctors that it really does work.

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.

Some confirmation here that how you apply Mirvaso is indeed important. As the effect is strong, it must be applied in a way to cover evenly all the areas that you want relief from the redness.

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.

Ok it is deliberately vague, but it is good to hear that Galderma has their sites on many other countries, and as soon as they can.

The second most asked question online is When will Mirvaso be available in Canada, UK, Australia, Ireland et. al.

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.

It was indeed a quick turnaround by the FDA, adding support to the idea that they were impressed with the clinical trial results. I was expecting approval not to be granted until around mid 2014. I’m sure many rosacea sufferer were happy to discover I was overly pessimistic.

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.

This of course refers to the Ivermectin Cream 1% product currently known as CD5024.

Why Galderma is Interesting

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.

Galderma is a key company for rosacea sufferers. They are the clear leaders in providing treatments and skincare for rosacea. Any recently diagnosed rosacea sufferer will come across Galderma when they get a script that says Metrogel 1% or Oracea, or indeed discover the Cetaphil Skincare Range.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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2 Reader Comments

  1. john says:

    probably going to cost them alot more than 100 million the way reviews are looking lol.

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