Voyageur Pharmaceuticals Provides Update on PEA Progress & Takes a Major Step Towards Production Start Up
Calgary, Alberta - TheNewswire - December 6, 2021 - Voyageur Pharmaceuticals Ltd. (TSXV:VM) (OTC:VYYRF) (the "Company" or "Voyageur") has a preliminary economic assessment (PEA) on its Frances Creek project pending with SGS Canada, who have stated the first draft will be completed by mid December. There have been delays outside of management's control. Building out the mining operation and product manufacturing represents the second phase of Voyageur’s plan.
Voyageur is working with its manufacturing partner; Alberta Veterinarian Laboratories / Solvet and has completed its first test batch of barium contrast media. Voyageur is working on clinical testing of this first batch to ensure quality and performance. Voyageur's goal is to complete testing for the Canadian product launch by February followed by a marketing campaign for sales into the Canadian radiology market.
Voyageur is focused in the near term on developing a suite of Computed Tomography products with the lead product being the SmoothX barium contrast brand. The FDA is currently working with Voyageur on creating a new regulatory pathway, to create a device registration. Voyageur expects to submit its device application as soon as the new guidelines are approved by the FDA. Voyageur will provide updates on FDA progress, as each milestone is achieved.
Voyageur plans to penetrate the US market upon completion of FDA device licensing, that is estimated to be completed in 2022. Voyageur is concurrently creating a drug dossier for foreign markets (EU/Uk/Japan) that regulate barium sulfate as a drug. Voyageur’s objective is to have regulatory filings for SmoothX into the UK, EU and Japan, and initiate the penetration into the global markets by end of 2022 to 2023.
Concurrently Voyageur is proceeding with multiple batch testing of its product to meet FDA and EU regulatory standards for licensing requirements. This work is directly tied into the FDA and EU regulatory approval process.
Voyageur is a Canadian public company listed on the TSXV under the trading symbol VM. Voyageur is focused on the development of barite and iodine Active Pharmaceutical Ingredients (“API”) and high-performance cost-effective imaging contrast agents for the medical radiology marketplace. Voyageur’s goal is to initially generate 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 sulphate (barite) projects including the Frances Creek property, suitable in grade for the pharmaceutical barite marketplace, with interests in a 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 radiology medical field, by controlling all primary input costs under the motto of: "From the Earth to the Bottle".
For Further Media Information or to set up an interview, please contact:
President & CEO
Forward Looking Information
This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to: the timing of the drafts and final PEA; the timing and success of the clinical testing of the first batch of barium contrast media and the subsequent marketing campaign, the timing and success of the registration with the FDA as a device or otherwise, the timing and success of penetrating the US and other markets, the timing and success of the Company's products meeting various regulatory standards, and the Company's long term plans, including with respect to becoming 100% self-sufficient with all manufacturing. 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.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this news release.