Voyageur Pharmaceuticals Ltd (TSX-V:VM, OTC:VYYRF) said it has completed the production test batch of its SmoothX barium contrast suspension for the computed tomography (CT) imaging market in Canada.
The company said this is a significant development as it transitions from the development phase to the production phase, where the focus will now be on scaling up the commercial volumes of SmoothX to supply the Canadian imaging market.
The Calgary-based Voyageur currently holds Health Canada-approved licenses for five barium contrast media products, and intends to continue advancing the development and testing of the remaining products for sales in the domestic radiology market.
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“The completion of production testing for SmoothX and the scale-up 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,” Voyageur CEO Brent Willis said in a statement.
“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,” he added.
In preparation for a generic drug submission to the US Food & Drug Administration (FDA), Voyageur has produced the recent batch in compliance with the requirements of the FDA and Health Canada.
The product batch that has been produced will be scaled up and, upon completing 180 days of 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.
Voyageur said the contract manufacturer of its barium contrast media product line recently received their FDA site registration, an important step in its plan to penetrate the US market.
Nevertheless, Voyageur said it continues to work on constructing its own certified pharmaceutical manufacturing facility. To date, it has completed the feasibility study and facility design and is currently finalizing the capital plan.
In the interim, the company will continue its relationship with the contract manufacturer for the production and testing of its imaging products for sale into the Canadian and US markets.
Voyageur is focused on the development of barium and iodine Active Pharmaceutical Ingredients (API) and high-performance cost-effective imaging contrast agents for the medical imaging marketplace. Its goal is to fully integrate the barium and iodine contrast market by producing its own minerals of barium and iodine.
The company has plans to build a carbon-neutral infrastructure to become 100% self-sufficient across all manufacturing activities. It owns a 100% interest in three Canadian barium sulphate (barite) projects, including the Frances Creek property, suitable in grade for the pharmaceutical marketplace, with additional interests in a high-grade iodine, lithium and bromine brine project in Utah, USA.
Voyageur is advancing its plan to become the only fully integrated carbon-neutral company in the radiology contrast media drug market, by controlling all primary input costs under the motto of 'From the Earth to the Bottle'.
Contact the author at jon.hopkins@proactiveinvestors.com