Tuesday, November 29, 2022
Voyageur Pharmaceuticals Ltd., announces completion of the production test batch of its SmoothX™ barium sulfate CT contrast media oral suspension for the CT imaging market in Canada. This development represents a significant transition for Voyageur from the development phase to the production phase, where the focus will change to scaling up to commercially viable volumes of SmoothX to supply the Canadian imaging market. Management estimates that these two milestones will likely speed up first commercial sales in Canada and the FDA filing for approval in the US.
Voyageur continues to advance the development and testing of four additional Health Canada approved imaging products for sales in the Canadian radiology market. Voyageur currently holds Health Canada approval licenses for five barium contrast media products.
Brent Willis, Voyageur’s CEO stated: “The completion of production testing for SmoothX and the scaleup to commercial quantities to launch sales in Canada is an important milestone for the Company. It also marks a key point in our journey to create a fully integrated Canadian supply chain for barium contrast media. It also supports Canada’s national strategy of de-coupling from China for the supply of critical minerals and critical pharmaceutical production. Basing our production testing on FDA protocols will advance our preparation for a generic drug submission to the FDA for the approval of SmoothX for gastrointestinal imaging. We have been engaged with the FDA on the path to approval for SmoothX since earlier this year and are now formally in contact with the FDA’s Office of Generic Drugs regarding the specific requirements of approval for SmoothX.”
In preparation for a generic drug submission to the US FDA, Voyageur has produced the recent batch in a manner that adheres to the Company’s FDA and Health Canada compliant quality management system. This system has been implemented to ensure that a consistent and high-quality product is delivered to Voyageur's customer base. The product batch that has been produced will be scaled up and, after completion of 180 days stability tests, will be submitted to the FDA as part of the application process for approval of SmoothX for sale in the United States market. This submission is expected to occur in the second quarter of 2023.
The Company contract manufacturer (CMO) of its's barium contrast media product line recently received their FDA site registration, an important step for the Company’s plan to penetrate the US market. Subject to financing, the Company continues to advance towards the construction of its own certified pharmaceutical manufacturing facility. The Company has completed the feasibility study and facility design phase and is currently finalizing the capital plan. In the interim, the Company will continue its relationship with its CMO for production and testing of its imaging products for sale into the Canadian and US markets.