MDVN - Medivation, Inc. - JMP Securities 2013 Healthcare Conference Transcript

    Ticker:MDVN
    Company Name:Medivation, Inc.
    Event Title:JMP Securities 2013 Healthcare Conference Transcript
    Event Date:09-Jul-2013
    Event Time:09:30 AM ET

    Presentation



    John Newman

    J.P. Morgan Securities
    Good morning, everybody. And welcome to JMP's Annual Healthcare Conference. My name is John Newman, I'm the Senior Analyst here at JMP covering Medivation. Very happy to have David Hung with us today, the CEO of Medivation. And David as I see has graciously agreed to do Q&A with us the entire time. So we should have plenty of time to answer everybody's questions.

    David Hung, M.D.

    President and Chief Executive Officer, Director
    I apologize I got second Q&A upstairs, so I have to answer questions here though.

    John Newman

    Analyst, JMP Securities
    Let me actually start out David if I could with one question -- what can you tell us about your core drug XTANDI in the breast cancer setting today? I know most of the focus is on XTANDI

    David Hung, M.D.

    President and Chief Executive Officer, Director
    Now that doesn't mean that 70% of breast cancer driven by AR, but 30% of them express it. And some fraction of those we believe are driven by the AR. And so if you look at the phase that we just started, we're starting a study in what is called triple negative breast cancer, but that's AR Positive.

    So triple negative means that they are ER Negative, PR Negative, HER-2 Negative and those patients cannot be driven by those receptors. And there is actually a pretty good literature that at least some of those patients will likely be driven by AR. So hope we've done by signing that studies and to reach the population that we believe is more likely to be AR responsive. So that's one way that we could be also have generated a preclinical data in our collaboration with the University of Colorado showing that XTANDI also inhibits estrogen BD in the breast cancer growth. Now that is a pathway that is separate from the AR, because estrogen works through a separate receptor called the ER.

    We know that XTANDI does not hit the ER, but as you know, the way receptors always work is that a - buying to receptor and that activates a number of downstream events and we believe that given the fact that we have shown to inhibit single preclinical studies.

    We believe that which has the possibility that XTANDI is working at some other target more difficult in that pathway, in estrogen pathway. So that really two possible ways that we could be working in breast cancer, one is to the AR pathway and hopefully see you at in the triple negative - but we also believe there is a possible a possibility that XTANDI could work against estrogen - and so I think those will be the two macros which we would expect to see some results.

    John Newman

    Analyst, JMP Securities
    Okay. Just had one addition question and then we will open it up to the floor. I'm just curious what do you think positions would like to see from the PREVAIL study? I know that no one had asked you about the PREVAIL study so

    David Hung, M.D.

    President and Chief Executive Officer, Director
    I think the physicians and patients really focused on three things as everyone does. It's efficacy, safety and convenience. And I think that we already have a pretty good handle of what the ball we have to beat is to be competitive in that landscape. And our major competition without a doubt is Zytiga. And I think that on the convenient side we have a once a day drug that can be given with or without food, that doesn't require steroids, that has no malfunction test monitoring, or - monitoring. So we think that on the convenient side XTANDI is pretty attractive and this is going to be pretty competitive.

    On the safety side, we've already shown in our previous firm study that XTANDI actually had lower serious adverse event from the drug arm and the placebo arm it's hard to say for most drugs so I think that makes it pretty attractive. We had a low seizure rate less than 1% in the post-chemo population. I think physicians would like to see a low seizure rate again in the pre-chemo population.

    And given the fact that most of the patients who had seizures in the AFFIRM study or much sicker patients and many had brain deaths, both of things that you don't tend to see in the pre-chemo population. So we think that XTANDI will hopefully have a very nice safety profile upstream, so I think docks will be looking for that.

    Then on the efficacy side, the bar of beat for us is pretty low because our main competitor Zytiga has not shown a survival benefit in pre-chemo patients. So, I think that the bar to beat is non-significant survival benefit. So and we hit statistical significant since I think that will be important in a couple of ways. Number one, it will allow us to market on that to promote on and we can actually claim that our drug has been proven to extensive - which I think would be a significant benefit.


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