There’s been a small bump in the road in Cyclopharm’s (ASX: CYC) plans to secure regulatory approval for Technegas™, their proprietary technology for lung imaging.
Technegas™ comprises ultra-fine radioactive labelled carbon that is exposed to high heat to create a gas that can be inhaled by the patient. The gas allows for comprehensive imaging to evaluate function and airflow within the lungs due to its ability to penetrate into sub-segmental areas of the lungs and lower airways. The gas makes imaging for conditions such as pulmonary embolism safe, economical and accurate. It is used in 60 countries and has been delivered to over 4.4 million patients for diagnosis of pulmonary embolism.
The radiopharmaceutical company has received a Complete Response Letter from the US Food and Drug Administration (FDA) in regard to their New Drug Application for Technegas™. The FDA has provided a list of recommendations for certain outstanding issues that need to be addressed within a 12 month period. Cyclopharm expects to resolve these and secure approval for Technegas™ with a view of commencing commercial sales in the US in 2022.
Cyclopharm’s Managing Director and CEO, James McBrayer said: “While the elements in the US FDA’s CRL are attainable within the required timeframe, we are disappointed with this news of the additional technical information requests. Effectively the CRL has extended the expected approval timeframe by around nine months.”
“We have complete confidence that we can address these matters and do what is required to expedite this process. We now have clarity as to what will satisfy the US FDA’s expectation and will commence work on the response immediately.”
Mr McBrayer added, “Since submitting the NDA, the Company has worked closely and constructively with the US FDA on matters relating to Technegas™ and we will continue to do so as we address the outstanding elements.”
Despite the revised time frame, Cyclopharm is hoping to bring Technegas™ to the US market in the second half of 2022 once all outstanding items raised by the FDA have been addressed. The addressable market in the US for Technegas™ is worth an estimated USD $180 million per year.
Cyclopharm has emphasised that they remain able to fund the remaining approval process and remain optimistic in gaining approval.
The Company is also working on expanding the indications for Technegas™ use for conditions affecting the lungs including COVID-19 to increase their addressable market.