not been able to get into our programs.
I see you sort of segued into my next question, which is, you know, this extremely concentrated center of excellence core that's treating this population. Can you talk about their level of anticipation? Clearly, the advocacy groups were, I think, instrumental in supporting your application and showing up at the advisory committee. It was pretty rare for me to see how many physicians actually testified at your advisory committee, which is pretty unique in my experience.
Yeah
... not just patients and caregivers. And so can you just characterize the level of interest and excitement, either with your principal, you know, and your people in your studies, but also perhaps beyond, with the treating community?
We have seen multiple physicians who are not part of our EAP program, or actually physicians who are running other EAP programs, 'cause patients can't be in two EAP programs at a time, provide commentary that they are interested in, and looking forward to an approval of arimoclimol that will allow them to actually put arimoclimol on top of their current therapies, because it would no longer be experimental, so we do see that those patients, those physicians are there in the other centers of excellence that would like to be able to participate in treating patients with NPC.
But now, taking it a step further, those nine hundred patients that are out there today, in my experience of launching rare disease programs, and I think most people who've been in the ultra-rare disease space, is you find out that when there's no treatment-
Right
... it's very challenging for a physician to have top of mind that that is a patient that could potentially be presenting with Niemann-Pick C. Once you get a therapy that's out there-
Right
... you all of a sudden start to see more diagnosis. That's the breadth of what our team is out there working with right now, educating on Niemann-Pick C and the potential, obviously, we're not promoting the product yet.
Right.
It's not approved, but the potential for therapies in the space.
It sounds like even within the currently diagnosed population, you're comfortable to say that there are more than your EAP population that are already primed, or, you know, there's sort of physicians with those patients beyond your EAP program who are already excited and ready to onboard or at least trial the product.
Yeah, we're looking forward to be able to help-
Okay
... those patients who have asked to be in our program that we're unable to treat, help-
Great
... help.
You also have a substantial ex-US expanded access presence.
Mm-hmm.
That's not something I even model yet, ex-US. But how do you think about the opportunity ex-US in terms of your ability to even get to market ex-US, regulatory front, and just how big that opportunity is?
We do. So, we have approximately seventy to eighty patients in our global EAP program. The majority of those patients are based in Europe. We have about thirty of those patients into the nominative ATU program, which is a pre-regulatory approval revenue type of program where they actually reimburse us. The other part of this is that we have been really focusing the organization on making sure that we could put together a robust package, and overcome the CRL, and the clock on the CRL to get an approval in the US. A lot of the questions that the CHMP had were also addressed as part of this process. You know, the duration of therapy. At the time, we had actually, you know, brought forward our package.
We had less than a year of EAP program-
Right
... so for us, in Europe. So for us, it's really an opportunity now to be able to recatalyze the application process in Europe, with the robust data and, knock on wood, a US FDA approval.
All right, so we got a late start here, but we still have time. I wanna pivot to your existing business, right? So Olpruva, which is your first commercial asset, it's been a little slower out of the gates, I think, than, you know, some of us had expected. Can you just talk about its differentiation in the UCD space and, you know, why it might be taking a little longer than expected to get traction since you acquired the product?
Sure. So, you know, we launched the product in January of this year after the previous sponsor had gotten approval but ran out of resources to really get it going. The launch metric I would consider right now are three buckets. The first bucket is: Do you have market access for the product? Our team has done a remarkable job on getting upwards of 75% of covered lives in the space right now. It puts us on par to be able to compete. The other part of the launch that I measure is: How are our commercial guys doing? Are they able to actually get access and talk about the clinical differentiation of the product with patients? We hired an extremely mature organization that's been able to get in there and really drive.
90% of our target base has been touched by our guys already. I think that's an important perspective. The last part is: How are the patients being activated in a mature UCD marketplace, where of the 1,000 patients that are out there, 800 are on therapy already? How are we doing with those? And I think that's an area that we have to continue to dive deeper in and continue to invest in patient awareness, 'cause a lot of folks didn't know that the product was being developed. And now we're actually able to get out there and start to work with the patient advocacy organizations and drive that increase in awareness level for the patient community.
How much synergy and overlap is there with arimoclimol for Olpruva? You know, clearly having boots on the ground is a help. Are they able to prime the pump, so to speak, at all ahead of an approval for arimoclimol? Conversely, is having arimoclimol actually gonna benefit your ability to get into offices that you might not be able to get into with another UCD product to educate them on the differentiation of Olpruva?
Yeah, that's right. I... Both.
Okay.
The answer to that is all of the above. We do think that the opportunity for us to have arimoclimol and the pull that we see from physicians today to be able to get in and open those doors will be important, but with an approval, it allows us to be able to also educate on Olpruva at the same time. Vice versa, the call points overlap about 80%, maybe even higher than that when it comes to the 40 centers of excellence in the US. So for us, it's a win-win. We believe that both of these will be synergistic and actually allow us to be able to have these conversations. Because patients on the Olpruva side, when they're stable on product, they may only see their physicians once every six to twelve months.
Right.
The opportunity for us to identify those patients and be in the office on a more regular basis-
Right
... as we're transitioning arimoclimol and educating physicians, puts us at a step up to getting more airtime.
You've had this nice pipeline slide up on the screen in front of everybody this entire time, and I don't think I mentioned three out of the five things on there. So just in our last thirty seconds, can you quickly just tell us on KP1077 for idiopathic hypersomnia, which is all upside to my model still, I'm just curious, are you still expecting an end-of-phase II meeting with the FDA, like, this fall, I think, or later this month? And what do you need to learn there to know what the next steps are gonna be and the timelines?
We do. Our end-of-phase II meeting is still scheduled before the end of the quarter, of which that'll help to inform our phase III program. And I think the important component of what we're looking to address is: Can we develop a program that's a phase III program that is, going to be able to differentiate itself with still the unmet need in, idiopathic hypersomnia, and that's sleep inertia, that ability for patients to get up and get going during the day?
Right.
That'll happen before the end of this month.
Okay, and I think we are actually up against it, so I apologize if I left any questions on the table. I'll have to do this again soon, hopefully after arimoclimol approval. And, so good luck in your upcoming, events, and talk soon.
Thanks for having us.
All right.