VYYRF - Recent Decision from DC Circuit Court Likely to Result in Less Cost and Faster Approvals for Voyageur Barium Products - Voyageur Hires Team of Experts to Support Product Roll-Out
(TheNewswire)
Calgary, Alberta – TheNewswire - April 20, 2021 – Voyageur PharmaceuticalsLtd. ( TSX.V : VM ) USA (OTC : VYYRF) (the “Company” or“Voyageur”), is pleased to announce that theD.C. Circuit Court of Appeals
has upheld a prior ruling that conclude d radiographic contrast agent bariumsulfate, qualifies as a device rather than adrug. This ruling has a significant impact on Voyageur’s plannedproduct roll out into the United States (US). Management of Voyageurestimates that ruling allows for significant cost savings and reducedtimelines to bring Voyageur’s products to the US markets. As a result of this ruling, thefiling 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 devicevary on the type of device and are expected to be significantly shorter than a drug registration . Until the FDA formulates the rules and regulations forfiling and approvals of barium as a device, Voyageur will be workingclosely with the FDA Center for Devices and Radiological Health (CDRH)to secure approval of Voyageur’s barium contrast media product lineunder a medical device pathway.
Voyageur has engaged a worldclass 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 consortiumof barium and iodine radiographic contrast media experts. Theconsultants have decades of work experience with EZ-EM Inc (including EZ-EM Canada) and BraccoDiagnostics Inc. Dash has expertise in bariumcontrast manufacturing, marketing of contrast media and related devices/accessories usedduring fluoroscopy, CT imaging and endoscopy procedures. The Dash teamhas extensive experience in contrast R&D, clinical testing,regulatory expertise, international sales, distribution networks, andnew drug/device R&D expertise. Consultants at Dash have been involved in the original formulations and roll out of bariumcontrast products that are currently being consumed in the marketplace.
Voyageur, by working with D ash, has commenced work on preparingfor product applicationsin markets globally . Thisincludes the US, UK, South America and South East Asia. Brent Willis,CEO of Voyageur states “this is a very significant ruling in theappeals 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 pacethan previously planned. By combining forces with Dash, we now havea team of experts in place to fully penetrate the global bariumradiographic contrast market. Upon completion of the PEA and Pre-Feasibility study,Voyageur anticipates full execution of it’s vision, From The Earth To TheBottle, the full integration of Voyageur’sbarium contrast product line”.
About Voyageur
Voyageur Pharmaceuticals Ltd. is Canadian publiccompany listed on the TSX Venture Exchange under the trading symbolVM. Voyageur is focused on the development of barite and iodine,Active Pharmaceutical Ingredient (API) minerals. The near-term focusis developing barium and iodine radio-contrast pharmaceuticalproducts. Voyageur’s goal is to initially generate near term positive cash flow fromoperations using third party GMP pharmaceutical manufacturers inCanada and internationally . Ultimately, Voyageur has plans to build all the requiredinfrastructure to become 100% self-sufficient with allmanufacturing. 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 ofbecoming the only fully-integrated company in the radiographiccontrast medical field, by controlling all primary input costs underthe motto of: "From theEarth to the Bottle"
** Source CostFDA https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
For Further Media Information or to set up aninterview, 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-lookinginformation and statements, including, without limitation, statements pertaining to savings and reducedtimelines to bring radiographic contrast products to the US market,approval of Voyageur's products for the US markets , the consultingcontract with Dash Consulting and global product applications andapprovals . All statements included herein, otherthan statements of historical fact, are forward-looking informationand such information involves various risks and uncertainties. Therecan be no assurance that such information will prove to be accurate,and actual results and future events could differ materially fromthose anticipated in such information. A description of assumptionsused to develop such forward-looking information and a description ofrisk factors that may cause actual results to differ materially fromforward-looking information can be found in the Company's disclosuredocuments on the SEDAR website at www.sedar.com. Voyageur does notundertake to update any forward-looking information except inaccordance with applicable securities laws.
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