Cyclopharm (ASX:CYC) US FDA progress for Technegas


by Anna Napoli

Cyclopharm (ASX:CYC) Managing Director and CEO James McBrayer provides an update on US FDA progress with Technegas, approval in Russia and potential use of Technegas in the diagnosis and management of COVID-19.

Anna Napoli: Hi, Anna Napoli for the Finance News Network. And joining me now from Cyclopharm (ASX:CYC) is CEO and Managing Director, James McBrayer. James, welcome back.

James McBrayer: Thanks, Anna.

Anna Napoli: James, when we last spoke in April, you had just submitted a new drug application with the US FDA for your product, Technegas. Can you provide us with an update?

James McBrayer: Sure. Since that April update, we've received a full waiver for the application in the US of 2.9 million US dollars. Last week, we received from the USFDA the designation of approval to file. And what that means is that they've reviewed our submission and making sure that all of the aspects are contained in there required for the review. And now approval to file means they're going to start looking at it from a qualitative point of view of safety and efficacy. We've also been notified that the time period in which they're going to review it is a 10-month timeframe. The approval to file is significant, and it gives us clarity on when we are likely to be available in the United States.

Anna Napoli: And what is the NDA pathway for the FDA, and when might we hear further news?

James McBrayer: Well, we expect over this 10-month period to receive questions from the FDA. We'll typically have an audit, although despite the fact that an FDA audit is of a very high standard, we're present in 60 countries around the world, so we're no stranger to the rigors of an audit process. We've commenced building our fleet of Technegas generators for launch once approval is granted. We've been engaging with key opinion leaders in the US and leading clinical centers interested in having the Technegas technology as early as possible. And we've also initiated our ground game in the US to establish the infrastructure required to launch our product there.

Anna Napoli: James, I understand last week was quite the week for Cyclopharm. In addition to the progress with the USFDA, you also announced receiving approval to market Technegas in Russia. Could you tell us more about the market size for Technegas and your marketing strategy?

James McBrayer: Yeah, we've been working on approval in Russia, Anna, for the last 10 years. The timing's right, actually, to enter in that market. Over the past 10 years, Russia has invested heavily in upgrading their healthcare infrastructure, and nuclear medicine has been a beneficiary of that upgrade program. The population of Russia is 144 million. There's approximately 200 nuclear medicine departments. This could grow into a significant market for Technegas. We've got one generator sold already through our partnership with HASCCA, which is Healthcare and Science Consulting Communications Agency. We've been working with them for the last three years in getting the final steps in approval in Russia, and we expect... Russia is going to be one of the last significant markets outside of the US that we've entered into, and we expect good things beyond PE in Russia with a high incidence of COPD in that market.

Anna Napoli: And turning to the use of Technegas in diagnosis and management of COVID-19, how has it been used and where?

James McBrayer: Well, I think imaging in general worldwide, we've seen a decrease, non-essential procedures, issues about access of personal protection equipment has been an issue, and we still don't know what the full impact will be with with this particular pandemic. But we expect the first half of... We'll see maybe a slightly cooling of our volumes, but we do note that restrictions are starting to be lifted in some of the markets where we're present. We know that functional imaging with Technegas has a place to play in this particular pandemic, although that the frontline is currently CT and x-ray, there's things you can't see with those modalities that you can identify through nuclear medicine.

We do know that in markets where Technegas is available and there's a high incidence of COVID that our product's being used in those markets. In fact, in April, the image of the month at the European Journal of Nuclear Medicine featured a patient in a French study showing the utility of Technegas in diagnosing what's called tracheal bronchitis. Those French same authors participated in a webinar last week emphasizing the unique characteristics of Technegas in working with COVID patients.

Anna Napoli: Last question, James, is there anything else you'd like to add?

James McBrayer: Well, last week was a huge wake for us. I mean, we underscored our focus on our core business with the entrance into a new market, Russia. We saw webinars and clinical journal publications that underscore the benefit and potential for Technegas in patients suffering from COVID-19. We've received clarity regarding the expected timeline for USFDA approval, and last but not least, we're very pleased for our shareholders, and most importantly, the patients Technegas can help during these challenging times.

Anna Napoli: James McBrayer, thank you for the update.

James McBrayer: Thanks, Anna.