Australian radiopharmaceutical specialist Cyclopharm Limited (ASX: CYC) has been granted a full application fee waiver of US$2.9 million related to its recently submitted New Drug Application (NDA) for Technegas by the United States Food and Drug Administration (USFDA).
Managing Director and CEO, James McBrayer, said the USFDA also fast-tracked the fee waiver review for Technegas, a nuclear medicine functional lung ventilation imaging agent.
“Whilst we were confident that we were eligible for a fee waiver, we are very grateful to the USFDA in their support of small business and the speed at which our application was granted. What normally takes three to four months to review, our request was granted in two months,” Mr McBrayer said.
“Our approval was based on our small business status; however, to de-risk the process, the company also submitted additional waiver applications under the categories of public health and a barrier-to-innovation.”
Mr McBrayer said the additional fee waiver applications contained supporting elements to include:
• Technegasprotects the public health because it has the potential to be a significant improvement compared to other marketed products;
• Technegasis intended for the diagnosis of a life-threatening condition; and
• Technegasas a diagnostic is innovative in seeking to expand its use beyond diagnosing PE.”
“Having recently submitted our Technegas New Drug Application to the USFDA, and now obtaining the full fee waiver, the next important step in the process is concluding the USFDA sixty-day review of our NDA submission for completeness and the subsequent granting of an Approval to File,” Mr McBrayer said.
“During this sixty-day period the USFDA will also determine if our application for Priority Review will be granted. The request for a Priority Review, as opposed to the Standard Review, will reduce our timeline to market by four months. Both Approval to File and the review period determination is expected to be decided by 27 May 2020.”
The United States is the largest nuclear medicine market in the world. Cyclopharm estimates the size of the US market for Technegasin diagnosing the presence of Pulmonary Embolism (PE) to be US$90 million in sales per annum.
“We expect to gain a 50% share of this market in the first 2 to 3 years, rising to 80% over 5 to 7 years.
“The company believes the extension of Technegas into new applications such as the diagnosis and monitoring of COPD, asthma and other respiratory disease states will create opportunities to exponentially expand the market for Technegas beyond its traditional PE market.
“Cyclopharm’s strategy to expand Beyond PE is being delivered by targeting new applications through clinical studies; educating clinicians; and engaging directly with respiratory medicine referrers.”
