Calgary, Alberta – TheNewswire - April 20, 2021 – Voyageur Pharmaceuticals Ltd. (TSX.V:VM) USA (OTC:VYYRF) (the “Company” or “Voyageur”), is pleased to announce that the D.C. Circuit Court of Appeals
has upheld a prior ruling that concluded radiographic contrast agent barium sulfate, qualifies as a device rather than a drug. This ruling has a significant impact on Voyageur’s planned product roll out into the United States (US). Management of Voyageur estimates that ruling allows for significant cost savings and reduced timelines to bring Voyageur’s products to the US markets. As a result of this ruling, the filing fees have been estimated to be reduced from US$196,868 to US$12,432 per product certification (**source below). The timelines to finalize and gain approval of a device vary on the type of device and are expected to be significantly shorter than a drug registration. Until the FDA formulates the rules and regulations for filing and approvals of barium as a device, Voyageur will be working closely with the FDA Center for Devices and Radiological Health (CDRH) to secure approval of Voyageur’s barium contrast media product line under a medical device pathway.
Voyageur has engaged a world class group of consultants through Dash Consulting LLC (DASH), to further accelerate the product roll out of it’s barium radiographic contrast products. Dash Consulting is a consortium of barium and iodine radiographic contrast media experts. The consultants have decades of work experience with EZ-EM Inc (including EZ-EM Canada) and Bracco Diagnostics Inc. Dash has expertise in barium contrast manufacturing, marketing of contrast media and related devices/accessories used during fluoroscopy, CT imaging and endoscopy procedures. The Dash team has extensive experience in contrast R&D, clinical testing, regulatory expertise, international sales, distribution networks, and new drug/device R&D expertise. Consultants at Dash have been involved in the original formulations and roll out of barium contrast products that are currently being consumed in the market place.
Voyageur, by working with Dash, has commenced work on preparing for product applications in markets globally. This includes the US, UK, South America and South East Asia. Brent Willis, CEO of Voyageur states “this is a very significant ruling in the appeals court, which will have a very positive impact for the company. Voyageur now has the ability to enter the US market at a much lower cost and significantly faster pace than previously planned. By combining forces with Dash, we now have a team of experts in place to fully penetrate the global barium radiographic contrast market. Upon completion of thePEA and Pre-Feasibility study, Voyageur anticipates full execution of it’s vision, From The Earth To The Bottle, the full integration of Voyageur’s barium contrast product line”.
About Voyageur
Voyageur Pharmaceuticals Ltd. is Canadian public company listed on the TSX Venture Exchange under the trading symbol VM. Voyageur is focused on the development of barite and iodine, Active Pharmaceutical Ingredient (API) minerals. The near-term focus is developing barium and iodine radio-contrast pharmaceutical products. Voyageur’s goal is to initially generate near term positive cash flow from operations using third party GMP pharmaceutical manufacturers in Canada and internationally. Ultimately, Voyageur has plans to build all the required infrastructure to become 100% self-sufficient with all manufacturing. Voyageur owns a 100% interest in three barium sulfate (barite) projects with interests in a potentially high-grade iodine, lithium & bromine brine project located in Utah, USA.
Voyageur is moving forward with its business plan of becoming the only fully-integrated company in the radiographic contrast medical field, by controlling all primary input costs under the motto of: "From the Earth to the Bottle"
** Source Cost FDA https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
For Further Media Information or to set up an interview, please contact:
Brent Willis
President & CEO
Ron Love
CFO
T 403.818.6086
E ronl@vpharma.ca
www.voyageurpharmaceuticals.ca
Forward Looking Information
This news release may contain certain forward-looking information and statements, including, without limitation, statements pertaining to savings and reduced timelines to bring radiographic contrast products to the US market, approval of Voyageur's products for the US markets , the consulting contract with Dash Consulting and global product applications and approvals. 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.sedar.com. Voyageur does not undertake to update any forward-looking information except in accordance with applicable securities laws.
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