Cyclopharm Limited (ASX:CYC) has opened up an alternative pathway for the approval of its Technegas generator following a meeting with the United States Food and Drug Administration (US FDA).
The Technegas generator produces a gas which is inhaled by patients before taking scans, to assist in the detection of respiratory diseases.
The newly proposed pathway is likely to allow for a faster market entry and reduced risk profile.
As a result, Cyclopharm is likely to be in a position to submit its New Drug Application for Technegas during the first half of 2019.
Cyclopharm managing director James McBrayer said: “Being allowed to submit a New Drug Application protocol for Technegas via a 505 (b)2 pathway significantly de-risks the FDA approval process, gives confidence to our timeline target to start sales of Technegas in the US in 2019 and is likely to reduce the anticipated overall costs (USD $7.5 million) of gaining approval USFDA substantially.
“We will redeploy any savings we make from adopting this alternative approval pathway to building the distribution, sales and marketing capabilities needed to initiate US sales in 2019.”
Aiming for 50% share of the US market
The US accounts for around half of the total addressable global market for Technegas.
The existing market for nuclear medicine ventilation imaging in the US is estimated to be about US$90 million annually, representing 600,000 individual procedures
Based on its Canadian experience, Cyclopharm believes that Technegas can achieve a 50% share of the US market over 2 to 3 years, post-market entry, with an 80% share representing about 480,000 procedures per annum achievable over a 7-year period.