VM:CC - Voyageur Pharmaceuticals Completes Milestone with the FDA and Continues to Move Towards Commercialization on Three Fronts
(TheNewswire)
Calgary, Alberta – TheNewswire - May 18, 2022: Voyageur Pharmaceuticals Ltd. (“ Voyageur ” or the “ Company ”) (TSXV:VM)is pleased to announce that it is progressing with its productdevelopment, regulatory pathway and material processing/manufacturingoperations that could result in revenue generation in Canada this yearand more importantly revenue generation in the United States earlynext year.
Product Development
As part of the product development process, Voyageurhas recently completed the design and testing of the first batch runsof its smoothie product line of barium sulfate contrast agents usedfor medical CT imaging. Further, the Company is currently workingthrough the scaled batch requirements for quality control and formeeting various regulatory requirements and specifications.
Once this testing is completed, the data will be usedto support the initial marketing and sale of the Company’s line ofbarium sulfate imaging products that are approved for the Canadianmarket and in tandem will be used for the Food and DrugAdministration (“ FDA ”) submission.
FDA Activity
Based on preliminary discussions with the FDA, Voyageurhas submitted extensive documentation for the first barium contrastproduct license application. Voyageur is currently scheduled to meetwith the FDA in June, to finalize submission requirements for thisproduct and once this application is approved, the Company plans onsubmitting applications for additional products.
Upon receipt of the application, the FDA may grant thelicense within 120 days, thus giving Voyageur the approval to marketits first barium sulfate contrast agent in the United States.
Voyageur’s plan for revenue generation is close tobeing executed, which will support financing and full integration ofthe Frances Creek project.
BariumProcessing/Manufacturing
Voyageur has engaged the engineering firm ACH EngineeringInc . ( “ ACH ”) to develop adetailed plan for the construction of two linked facilities. An ActivePharmaceutical Ingredient ( “ API ”) plant torefine the barium concentrate from its quarry into an API gradeproduct. ACH will design the automated Good Manufacturing Practice(“ GMP ”) drug and device pharmaceutical manufacturing facility.
These two facilities will become the foundation of theonly fully integrated and totally controlled entry into the globalimaging market for barium sulfate contrast agents. This control isintended to provide Voyageur with a low-cost advantage that shouldsupport the gaining of market share and improved margins.
Upon completion of the facility designs and detailedcost and schedule, Voyageur will begin to seek financing for thisstrategic buildout of the Company’s fully integrated drug and devicemanufacturing.
Voyageur recognises the strategic value of being fullyintegrated, owning and extracting its own APIs. The Company’s bariumresource is critical and strategic for customers, currently threatenedby global supply chain constraints and increasing geopolitical risks.Voyageur will be able to provide supply security to customers overlong-term contracts, with reduced risk to supply disruptions andvolatility.
About ACH Engineering Inc
ACH Stands for “A Cleanroom Hub”, which is its corebusiness moto that enables ACH to push its boundaries and, expand tobe a specialized controlled environment solutions provider, operatingfrom Ontario to Alberta (Canada) and covering the North Americanmarket needs.
ACH's story starts with its clients, whether itsclients need a controlled environment or a cleanroom for a LAB,Manufacturing Process or any other application ACH stands behind itsclients and the clients business needs by understanding their processrequirements. ACH then tailors the optimized solution and converts itinto reality.
ACH’s unmatched capabilities stem from its people whocarry outstanding qualifications and experience to provide robustturnkey solutions that contribute to the clients vision.
Contract Manufacturing
Alberta Veterinarian Laboratories (“ AVL ”) has completedconstruction of their GMP pharmaceutical plant. The plant isoperational and has completed testing and passed inspections. AVL iscurrently ramping up production for over thirty products. AVL's goalis to produce over 50 products including Voyageur’s barium contrastproduct line.
About Voyageur
Voyageur is a Canadian public company listed on theTSXV under the trading symbol VM. Voyageur is focused on thedevelopment of barite and iodine API and high-performancecost-effective imaging contrast agents for the medical radiologymarketplace. Voyageur’s goal is to initially generate positive cashflow from operations using third party GMP pharmaceuticalmanufacturers in Canada and internationally. Ultimately, Voyageur hasplans to build all the required infrastructure to become 100%self-sufficient with all manufacturing. Voyageur owns a 100% interestin three barium sulphate (barite) projects including the Frances Creekproperty, suitable in grade for the pharmaceutical barite marketplace,with interests in a high-grade iodine, lithium & bromine brineproject located in Utah, USA.
Voyageur is moving forward with its business plan ofbecoming the only fully integrated company in the radiology medicalfield, by controlling all primary input costs under the motto of:"From the Earth to the Bottle".
For Further MediaInformation or to set up an interview, please contact:
BrentWillis
President &CEO
www.voyageurpharmaceuticals.ca
Ron Love
CFO
T403.818.6086
Neither the TSX Venture Exchange norits Regulation Services Provider (as that term is defined in thepolicies of the TSX Venture Exchange) accepts responsibility for theadequacy or accuracy of this news release.
Cautionary Statement Regarding“Forward-Looking” Information
This news releasemay contain certain forward-looking information and statements,including without limitation, statements pertaining to: the timing ofrevenue generation in Canada and the United States; the timing andsuccess of the development of the Company's products including thesmoothie product line of barium sulfate contrast agents; the Company'sproducts meeting various regulatory requirements and specifications;the timing and success of the Company's licence application to theFDA; the timing and success of the Company's financing, design andconstruction of the API plant and GMP drug and device pharmaceuticalmanufacturing plant, manufacturing costs and margins and whether themanufacturing costs will be low enough to provide the Company with asufficient advantage to gain market share over other competitors;AVL's ability to manufacture Voyageur's barium contrast product linein a timely and cost effective manner; and the Company's long termplans, including with respect to becoming 100% self-sufficient withall manufacturing. All statements included herein, other thanstatements of historical fact, are forward-looking information andsuch information involves various risks and uncertainties. There canbe no assurance that such information will prove to be accurate, andactual results and future events could differ materially from thoseanticipated in such information. A description of assumptions used todevelop such forward-looking information and a description of riskfactors 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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