Biotech Values

[dewophile]

RVNC/EOLS

more color on pricing from the cc:

The key point here is that, we price Jeuveau at a slight premium to the market leader and we will roll out the different pricing levels to doctors in terms of the volume-based pricing once we get past the launch date and then towards the end of this year, we will introduce our consumer loyalty program which is designed to make this procedure more affordable to patient.

In the end, your point is exactly right. We anticipate that the market will price Jeuveau at parity to the market leader or slightly above in some cases as we’ve heard that patients should not expect to pay less for Jeuveau given the quality of data that we’ve generated and the premium brand that we are bringing to the market.

They seem to think their data supports a slight premium to botox. The 30 day endpoint had a numerically higher response rate by about 5% vs botox (both were lower than the RVNC data at a similar time point FWIW). I don't think EOLS has reported data beyond 30 days yet and I didn't see any duration claim in their label

Also RVNC came up in the Q&A which may be of interest to the board:

Good afternoon. Revance issued a statement to analysts today that points to your pre-BLA meeting minutes for Jeuveau and it says based on feedback from the FDA in the written document, the stated duration is not based on a two point comparison to placebo as Evolus has been claiming, but against a threshold level determined at the design stage.

So, first, had you been claiming that? So I wasn’t familiar with that. So I was glad that you’ve raised that. The second is give a comment about it. And then third, Allergan say that they don’t think Revance will get six months labeling and I know Irina had asked earlier about what is your expectation of that.

Is there any reason for you to think that they will or won’t get six month labeling or a 24 week labeling? Thank you.

David Moatazedi

Yes, first of all, thank you for the question. What we’ve stated is just in reference to what the FDA guidance has. And in 2014, the FDA said, it’s something along the lines of duration, claims should be based effectively on a Kaplan–Meier of the primary endpoint. And the primary endpoint is a two point composite. So that’s all that we’ve been claiming.

The pre-BLA or pre-BLA meetings are kind of in the public domain and that’s what you are referring to, Revance. I was looking at that document. But if you heat it closely, that’s not what we see in that document either. So I think there is a little bit of confusion from Revance in terms of how they are interpreting the question and the response from the FDA.

And I can go into more detail if that doesn’t explain to you. From our perspective, we have a long call, a conference call little while ago and we just said we don’t have a duration claim in our label. What we went through in – what we put in our label was try to give physicians and patients visibility in terms of how they should think about retreatment.

So in our particular label, what we thought was most helpful for doctors and patients to understand kind of what a retreatment cycle would look like is by looking at our open-label Phase II study which is very real world where patients came in when they lost their correction and went to a zero or a one. And in that open-label study, over the course of the year, and actually two studies there were 922 patients.

The typical patient came in three times a year. So that we thought that was more informed after all the label is supposed to help clinicians and patients understand what they do. Your last question is really important question of course is, Revance and what their label may or may not read and really I mean we have no insight into that.

So it’s a fair question, but we wouldn’t be able to answer that responsibly and that’s a good question for the Revance folks.

Note that in hte pre-BLA minutes for evolus they asked if they can get a duration claim based on when statistically significant differences from placebo last and were shot down because the FDA (appropriately) said that you cannot claim duration at late time points when you have very few responders left even if it is greater than placebo i.e. if 5% are responders vs 0% placebo it is not clinically meaningful
To claim duration you have to determine the threshold of responders a prior per those minutes. The FDA label for botox states duration up to 120 days and at that 120 day endpoint the responder rate was in the 20% and change rate for botox so that seems to be a minimum response rate to claim a duration probably.