Cyclopharm Limited (ASX:CYC) CEO & Managing Director James McBrayer talks about USFDA approval for Technegas, the company's USA commercialisation plan, and opportunities beyond its key diagnostic market for pulmonary embolism.
Hello, Melissa Darmawan for the Finance News Network. Joining me from Cyclopharm is CEO and managing director, James McBrayer. James, welcome back.James McBayer:
Thanks, Melissa. It's great to be here.Melissa Darmawan:
Cyclopharm is a leader in diagnostics and lung imaging with this Technegas product. Can you bring our audience up to speed with progress this year?James McBayer:
Sure. Well, I guess our biggest advancement is certainly the filing for our new drug application with the USFDA. The USA is the largest healthcare market in the world. In fact, in terms of nuclear medicine, half the world's nuclear medicine departments are in the US.Melissa Darmawan:
Thanks for that, James. And what is the size of the lung imaging market and specifically where is Technegas used?James McBayer:
Well, the lung imaging market is vast, actually. The area that we're best known for is diagnosing pulmonary embolism. Pulmonary embolism is a life-threatening condition. And when you look at what the market potential for the US looks like, there are over 4 million patient studies done in the US to determine pulmonary embolism. Nuclear medicine accounts for only about 15% of those because they don't have an agent like Technegas to provide the highest level of diagnostic outcomes.Melissa Darmawan:
And James, you mentioned a key focus has been a USFDA approval. What is the history of diagnosis for PE in the US and when do you expect to begin selling Technegas there?James McBayer:
And it's one that we are going to be almost a catalyst, we believe, for a resurgence of nuclear medicine lung imaging in the US. In the US, they predominantly use two-dimensional imaging, planar imaging because they don't have the agents available to them that can provide the three-dimensional imaging on a consistent basis that Technegas can provide. In fact, when you look outside the US to Europe, our largest region, or Canada, our largest single country market, Technegas is seen in their guidelines as the agent of choice. So, when we get into the US, we believe that there'll start to be a shift towards more three-dimensional imaging which will drive more demand for the technique.Melissa Darmawan:
And what will the US market mean for sales?James McBayer:
Well, we look at the US market in three different stages. Certainly, the first stage is the addressable market, which is that 90 million US dollars. And we think that we'll get 80% of that in the first three to five years, so 72 million. But we also believe with the technology that Technegas actually allows the clinician to leverage, we'll start to whittle away at that from a 15% market share to a 30% market share. So, adding another 90 million US dollar potential.
But we believe, and what's really exciting for us, even from a global perspective, Mel, is the beyond PE applications that we're starting to see more and more with the use of Technegas and that's exponential potential for the company.Melissa Darmawan:
James, you used the term beyond PE to talk about opportunities other than in the diagnosis of pulmonary embolism. What are those opportunities and how does it compare to the PE market?James McBayer:
We have seen the applications of our product used anecdotally in other applications, we actually see the potential in not only diagnosis but actually patient management. To see if the treatment that that clinician has chosen for a particular patient is actually working. And what's a better way of understanding that is to actually understand how well that lung is being ventilated. The areas that we're looking at predominantly to target in that patient management area is probably the largest and the one that we believe that will be more helpful to the clinician in is areas like COPD and asthma, where half a billion people suffer from that every day.Melissa Darmawan:
Last question, James, is there anything else you would like to add?James McBayer:
We submitted our new drug application at the beginning of this year, in March, we had approval to file in May. We have our PDUFA date which is the date that the FDA sets as their determination date, is the 27th of March of next year. So, we're busily moving towards that with a Q&A that goes back and forth with the FDA which is quite common. And I think the only thing that really is outstanding at this stage is a site audit. That being said, as many of our shareholders know, we're in 60 countries around the world. We've had over 4.3 million patient studies done. We would be probably the most audited organization that you could possibly think of.
So, I'm just calling in from hotel quarantine, where I've been in the US for the last five weeks. I'm eight days into my 14-day stint. And the other element, certainly USFDA is important, but also getting our ground gang ready to go for commercialization is important. So, I've spent the last five weeks in finalizing shortlists of third-party logistics, service engineers, applications people, and also establishing some back-office support. So, when we get the green light from the FDA, we'll be ready to go,Melissa Darmawan:
James McBrayer, nice to meet you. Thanks for the update.James McBayer:
Thank you, Mel.Ends