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Replies to post #221866 on Biotech Values
Timothy Lugo
Understood. And maybe one last question. Can you talk about the chronic migraine indication? I know you thought about starting of Phase II in that indication. Obviously, the CGRPs had a strong launch in the first quarter or so. Is that market still as attractive as you may be viewed in the past?
Daniel Browne
Look, our focus is on the two largest markets for the neuromodulators, the facial aesthetics and then on the muscle movement. Those are validated markets of which we believe we have a product that with significantly longer duration will differentiate itself. And there isn't a competitive alternative that's within sight relative to the advantages that come with RT002. We've said that we wouldn't move forward with the migraine trial until we had the chance to see how the - CGRPs played out. And if we could establish a proprietary position that had something demonstrably different in the current use of neuromodulators. You've got 40 million sufferers of chronic migraine headache, and there's no one product in our view as we speak to the neurology key opinion patients that will do all patients. You've got 13 million that have prophylactic treatment, you've got about 10 million that are episodic and you've got 3 million to 4 million that are chronic. What's interesting as the field plays out, you've got many of these new CGRPs that are new to the market, they're not existing in the market.
Most of the patients who've switched from Topamax and others have been the ones that switched, not the neuromodulators. I think it was very encouraging when the market leader reported that was only about 1% or 2%, I believe, they reported that it's switched out at BOTOX. So our view is this chronic migraine headache will continue to grow. It may not grow at the same rate that it has historically. But there will be a need from neuromodulators and if you look at the patient care of those 40 million sufferers, some will sort of move to the CGRPs, some will be Topamax and those type of molecules and some will stay and grow within the neuromodulator. So will that play out. We're currently working on the proprietary position in the study protocol, and we'll get back to you. We said we wouldn't start that work until 2019 at the earliest. And by then, we'll have more information on how the CGRPs are gaining traction and in which patient population they're gaining traction.
Michael Ingerman
This is Mickey Ingerman on for David. It sounds based on your comments, but the protocol's still in the works, but for the study in chronic migraine, can you guys talk a little bit more about your thinking around the design of the study? And specifically, whether or not there's plan to incorporate Botox as a competitor?
Daniel Browne
I'll take the high-level sort of strategic considerations. I'll let Abhay talk about more of the specifics. What we'd like to do is really go after that chronic population and much as we've done in other indications move from four treatments a year to something demonstrably left. And if we see that same extended duration, we think that it's possible to go to twice-a-year dosing relative to what we're at today. We also would like to look at a more tolerable procedure. Today, out by label, you're at about 31 injections. There is a little bit from investigators and from clinician to clinician. But if we think if we can get something to demonstrably less, that we would both address the long-term benefits and use of these neuromodulators, and have a more tolerable procedures for patients, but also a procedure that's easier for physicians to integrate into their practice. We've never expected that the CGRPs to address all patients. I think when you look at the response rates, they will clearly find a role in those patients, but the chronic migraine market has continued to grow, and we'll see what happens. We'll stand by and watch that, but I think from a study design, we want to look at those patients who are not responding to either the neuromodulators or to CGRPs and other molecules and see if we can capture a study design that differentiates this potential product. If we, at the end of the day, don't feel that we can do that, there's no shortage of indications that we can go work on.
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