Cyclopharm Limited (ASX:CYC) Managing Director and CEO James McBrayer provides an update on the company's US Phase 3 trial for Technegas, and USFDA approval process timeline, with commercial sales expected in the US for 2021.
Rachael Jones: Hello. I'm Rachael Jones for the Finance News Network. Joining me today from Cyclopharm (ASX:CYC) is CEO and Managing Director James McBrayer. James, welcome back to FNN.
James McBrayer: Thanks, Rachael. Great to be here.
Rachael Jones: Now, first up, James, can you tell us about your good news about the Phase 3 trial for Technegas in the US?
James McBrayer: Thanks, Rachael. I guess second only to our submission that we made, our NDA submission earlier this year to the FDA, this is probably the single most important announcement the company's ever made. The successful outcome of this trial as deemed by the data monitoring committee, was several years in development and, quite frankly, decades in the making.
Rachael Jones: And so what does this mean for the Phrase 3 trial?
James McBrayer: Well, it means, in short, we'll be able to terminate it because of success. The Phase 3 trial was designed as a comparative to a product that's available in the US. It was a non-inferiority study that was supposed to go to 240 patients. Given what was happening in the United States with COVID 19, it wasn't likely that we would have gotten to the full 240 in a reasonable amount of time. We'd already gotten to 204. The FDA had asked us to form this data monitoring committee blinded to the data so that we couldn't be biased by the process. And because of the successful outcome, because of the fact that we reached its primary endpoints, and now that we've unblinded that data, we now are confirmed that we've actually met the secondary endpoints as well. We've notified the clinical trial sites that we're planning on terminating the study itself, and we'll be closing those sites out in a very orderly way. In parallel with that we'll finalise the report, bring in both the safety data that we've been collecting all along and combine that with the efficacy data and submit that as an addendum to our new drug application that they're currently reviewing.
Rachael Jones: And James, now let's go back to your USFDA application. What's next? And when do you expect to get final approval on that?
James McBrayer: Well, the review date for the FDA hasn't changed. They've given us to the end of March 2021. That's called a PDUFA date. They have certain targets internally, KPIs, that they put upon themselves to review these types of files. And so that's our target date. We're working toward that date. I've been impressed with and grateful for the collegial manner in which the FDA is engaging with us. The FDA has conducted a mid-cycle review a couple of weeks ago, and we've had a conference call on that. There was some questions that came out of that process. There are questions that have been posed to us throughout. That's not unusual. We're just working through them systematically. In fact, we've got a rather large submission going in today, some 70 pages as a supplement.
Rachael Jones: And James, how important is access to the US market for Cyclopharm?
James McBrayer: Well, Rachael, it's extremely important. Half the world's nuclear medicine departments are in the US. We're in the other half, we've got coverage in 60 countries around the world. We're first in class in all of those countries in which Technegas is available. We expect that same success in the US when we launch there. And in fact, it's become even more somewhat of an imperative to launch in the US. The competitive products that are available in the US in comparison, ours has been deemed to be, from an operational and a safety point of view, better in this COVID-19 pandemic environment. We're safer from an administration point of view and exposure, potential exposure, point of view from the operators and the equipment that is used to image these patients. So, there is a pent up demand, not only for our technology, but an imperative because of what's happening globally.
Rachael Jones: And to the last question now, James. Is there anything else you'd like to add?
James McBrayer: I guess, Rachael, just to wrap things up, we're very, very proud of the milestones that we're reaching, not only for the company, but most importantly, our shareholders. We're coming to a very important juncture in the company's history. We've had over three decades of clinical use with our products. It's best in class throughout the world. We've had, as I said, 60 countries in use, hundreds and hundreds of clinical papers in support of our product. We are referenced in numerous international guidelines as the agent of choice. We're just very excited about bringing this technology to the United States. Where we are right now is we're taking that next step in working on our ground game in the US, now that things are getting closer and closer. So we will be looking forward to updating our shareholders as we tick off some more milestones and get closer to that launch date in the United States.
Rachael Jones: And we'll very much look forward to that. James McBrayer, thanks so much for the update and congratulations on the milestone.
James McBrayer: Thanks, Rachael.