Voyageur Pharmaceuticals has announced that it is progressing with its product development, regulatory pathway and material processing/manufacturing operations that could result in revenue generation in Canada this year and more importantly revenue generation in the US early next year.
As part of the product development process, Voyageur has recently completed the design and testing of the first batch runs of its smoothie product line of barium sulfate contrast agents used for medical CT imaging.
Further, the company is currently working through the scaled batch requirements for quality control and for meeting various regulatory requirements and specifications.
Upon completion of the facility designs and detailed cost and schedule, Voyageur will begin to seek financing for this strategic buildout
Once this testing is completed, the data will be used to support the initial marketing and sale of the Company's line of barium sulfate imaging products that are approved for the Canadian market and in tandem will be used for the FDA submission.
Based on preliminary discussions with the FDA, Voyageur has submitted extensive documentation for the first barium contrast product license application. Voyageur is currently scheduled to meet with the FDA in June, to finalise submission requirements for this product and once this application is approved, the company plans on submitting applications for additional products.
Upon receipt of the application, the FDA may grant the license within 120 days, thus giving Voyageur the approval to market its first barium sulfate contrast agent in the US.
Voyageur's plan for revenue generation is close to being executed, which will support financing and full integration of the Frances Creek project.
Infrastructure for barium processing/manufacturing
Voyageur has engaged the engineering firm ACH Engineering (ACH) to develop a detailed plan for the construction of two linked facilities.
An Active Pharmaceutical Ingredient (API) plant to refine the barium concentrate from its quarry into an API grade product. ACH will design the automated Good Manufacturing Practice (GMP) drug and device pharmaceutical manufacturing facility.
These two facilities will become the foundation of the only fully integrated and totally controlled entry into the global imaging market for barium sulfate contrast agents.
This control is intended to provide Voyageur with a low-cost advantage that should support the gaining of market share and improved margins.
Upon completion of the facility designs and detailed cost and schedule, Voyageur will begin to seek financing for this strategic buildout of the company's fully integrated drug and device manufacturing.
Voyageur recognises the strategic value of being fully integrated, owning and extracting its own APIs. The company's barium resource is critical and strategic for customers, currently threatened by global supply chain constraints and increasing geopolitical risks. Voyageur will be able to provide supply security to customers over long-term contracts, with reduced risk to supply disruptions and volatility.