Cyclopharm (ASX:CYC) submits FDA approval for Technegas


by Rachael Jones

Cyclopharm (ASX:CYC) CEO & Managing Director, James McBrayer talks about its new drug application with the US FDA for Technegas and applications beyond pulmonary embolism in chronic chronic obstructive pulmonary ( COPD ) and asthma.

Rachael Jones: Hello. I'm Rachel Jones for the Finance News Network. Joining me today from Cyclopharm is CEO and managing director James McBrayer. James, welcome back to FNN.

James: Thank you, Rachel. It's great to be here.

Rachael Jones: Now, James, on Monday you announced that you've submitted a new drug application with the US FDA for your product Technegas. What is the significance of this for Cyclopharm?

James: Quite frankly, it's the single most significant announcement that the company has ever made. We're in 59 countries around the globe, but achieving the US FDA approval will give us access to the largest healthcare market in the world. It's a game changer for the organization.

Rachael Jones: Thanks James. So, what are the next steps for the FDA now and when might we hear new updates?

James: We're currently in review phase with the FDA, and what that means is they're looking for the completeness of our submission, if all sections are accounted for. We believe that it is. Also, during this 60 day period, we're also expecting to get a determination from the FDA whether or not our application, that was submitted in parallel with the NDA for a priority review, is accepted. The difference between a priority review and a standard review is about four months. So, the priority requests that we put forward, and we think that we've made a very strong case for, an expedited review. What that means is from the 60 day review period, a priority review means that the FDA will look at that application within a six month period.

Rachael Jones: And James, what is the market opportunity for Technegas in the US? What are your assumptions on market share growth and revenues?

James: United States is the largest nuclear medicine market in the world. Half the world's nuclear medicine departments are in the US. We estimate that the size of the US market for diagnosing pulmonary embolism, what we're best known for using Technegas for, is around 90 million US dollars. To give you some idea of in contrast, last year global sales for Technegas was around 14 million Australian dollars. So, a step up from $14 million to a $90 million market opportunity in the US is significant. We expect that we'll be able to, given history in other markets, and most recently in Canada, that we should be able to gain a 50% market share in the United States within a two to three year period, growing to about 80% in that five to seven year period.

Rachael Jones: And what is beyond [inaudible 00:02:54] for Cyclopharm? What could these mean for the company in say, five to 10 years?

James: Put simply, exponential growth opportunities. We're best known for a very niche area of diagnostic imaging, diagnosing pulmonary embolism, but with the advent of new technology, specifically the 3D imaging or otherwise known as SPECT imaging, combined with the analytical software that the quantification and artificial intelligence has to offer, as well as the hybrid imaging. So, you're not only getting a nuclear medicine scan, but you're also able to get a CT scan at low dose. So, we get the best of both worlds. We're seeing functional imaging through nuclear medicine combined with anatomical imaging that CT gives you, combined with the technology to analyze various disease states and quantify that for clinicians in a manner in which that they've never had access before.James: Whilst we're best known for pulmonary embolism, we see these applications going farther into respiratory care. We see this technology being applied in chronic indications like COPD and asthma. Each one of those are 30 times larger than the pulmonary embolism market. The difference in patient management in chronic conditions is in PE we only see the patient typically once in a critical care situation. What we think that the applications for Technegas would be in these chronic conditions is we would manage a patient over time.

Rachael Jones: And James, we have to mention it, can you tell us about the impact of Covid19 on Cyclopharm?

James: It's certainly trying times and it's still very, very early days. However, our product is used in respiratory medicine and one of the symptoms of Covid19 is shortness of breath, very similar to a symptom that's typically seen in pulmonary embolism. And we're not first line testing, or we're not a first line testing procedure that's done through straightforward clinical tests, a laboratory test to find the extent of the virus. We are seeing CT being used and we're getting some anecdotal reports of late that, for example, in France our largest country market in Europe and second only to Canada in the world, they're actually reporting on their website that they're expecting to see an increase in lung imagings. And they specifically named Technegas as an agent used in this ventilation procedure, because of just the sheer volume of patients going through CT they just can't cope with the load. So, there is a natural flow on into nuclear medicine. But again, it's still early days and those are anecdotal growth opportunities.

Rachel Jones: James McBrayer, thanks so much for the update and stay safe.

James: Thank you.