Voyageur Introduces Five New Barium Contrast Formulations Setting New Standards in Medical Imaging Industry

September 05, 2024 (Source) — Voyageur Pharmaceuticals Ltd. (TSX.V: VM) (USA: VYYRF) (“Voyageur” or the “Company”) announces that in an innovative endeavor, it has completed formulation work on its new product line of 5 Health Canada licensed products. Voyageur has engineered these advanced formulations to improve existing market standards, prioritizing enhanced value for stakeholders. By introducing distinct brands, Vision and Smooth barium contrast agents, Voyageur brings versatility and performance to medical diagnostics. Notably, these products will be classified as new drugs under the 505(b)(2) FDA drug pathway, a streamlined process that enables drug approval based on existing data sources, expediting approval timelines and reducing costs compared to a full NDA submission.  Creating new products versus manufacturing generic products creates a new level of competitiveness for Voyageur.

Voyageur has completed multiple test pilot batches for its full suite of products and is now proceeding with pilot batches for patient testing.  Voyageur is progressing to the final phase of clinical testing, utilizing its products in patients for X-ray and Computed Tomography (CT). Upon the completion of these evaluations, focusing on the quality of imaging results, Voyageur plans to launch its products in the Canadian and International markets. The patient trials are anticipated to take approximately two months, encompassing comprehensive analyses of imaging scans and the preparation of independent white papers for each product. All testing is following guidelines for future FDA licensing.

Brent Willis, CEO of Voyageur, explains, “Voyageur highlights that transitioning from generic formulations to a more sophisticated product line demanded a significant investment of time and resources. This strategic shift is projected to deliver long-term advantages. After rigorously assessing each product’s performance, Voyageur intends to seek FDA approval for these formulations in the U.S. market through the 505(b)(2) drug licensing pathway, positioning them as new drugs. This strategy is designed to expand the Company’s portfolio by creating new intellectual property, thereby securing a competitive advantage. We have numerous customers eager to upgrade their current product lines to our newly developed offerings.”

About Voyageur Pharmaceuticals Ltd.

Voyageur, a Canadian public company trading under the symbol VM on the TSXV, is in development of barium and iodine Active Pharmaceutical Ingredients (API) and offers high-performance, cost-effective imaging contrast agents. With a strategic focus on vertically integrating the barium and iodine contrast market, Voyageur aims to become a key player by producing its own barium, iodine, and new endo fullerene drugs.

Voyageur’s business plan is set to generate cash flow by partnering with established third-party GMP pharmaceutical manufacturers in Canada, ensuring the validation of its products by regulatory agencies worldwide. As Voyageur solidifies its presence in the market, it plans to transition into a high-margin domestic manufacturer of radiology drugs, further expanding its revenue streams.

Voyageur is committed to sustainability and environmental stewardship. Voyageur envisions a future where reducing carbon emissions is the norm, and to achieve this, it will build state-of-the-art carbon-capture infrastructure utilising the Rain Cage EDEN^TM system. By investing in carbon capture energy sources and sustainable manufacturing practices, Voyageur aims to generate revenue from carbon captured “advanced carbon production” to accelerate growth. Voyageur’s unwavering commitment to the environment sets it apart as a pioneer in the industry.

At the core of its operations, Voyageur owns a 100% interest in the Frances Creek barium sulphate (barite) project. Currently, the worlds pharmaceutical barium sulphate is almost entirely synthetically produced resulting in a less effective imaging quality product. Voyageur’s Frances Creek resource boasts a rare and exceptional grade mineral suitable for the pharmaceutical marketplace that will replace the current synthetic products with higher quality imaging products.

Voyageur’s ambitious vision is to become the first vertically integrated company in the radiology contrast media drug market. By controlling all primary input costs, from the sourcing of raw materials to the final production, Voyageur ensures quality and cost efficiency. With its approach, it embodies the motto of “From the Earth to the Bottle,” highlighting Voyageur’s commitment to responsible sourcing and manufacturing practices.

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Cautionary Statement Regarding “Forward-Looking” Information

This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to: the successful completion of clinical testing, FDA and other regulatory approvals, and the success of the five new barium contrast drugs. All statements included herein, other than statements of historical fact, are forward-looking information and such information involves various risks and uncertainties. There can be no assurance that such information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such information. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR+ website at www.sedarplus.ca. Voyageur does not undertake to update any forward-looking information except in accordance with applicable securities laws.