Twitter

Link your Twitter Account to Market Wire News


When you linking your Twitter Account Market Wire News Trending Stocks news and your Portfolio Stocks News will automatically tweet from your Twitter account.


Be alerted of any news about your stocks and see what other stocks are trending.



home / news releases / VM:CC - Voyageur Pharmaceuticals Ltd. Completes Medical Imaging CT Contrast Agent Production Testing and Begins Production Scale-up of SmoothX (TM)


VM:CC - Voyageur Pharmaceuticals Ltd. Completes Medical Imaging CT Contrast Agent Production Testing and Begins Production Scale-up of SmoothX (TM)

(TheNewswire)

Calgary, Alberta – TheNewswire - November 28, 2022 :Voyageur Pharmaceuticals Ltd. (TSXV:VM) ( OTC :VYYRF) (the "Company" or"Voyageur") announces completion of the production testbatch of its SmoothX™ barium sulfate CT contrast media oralsuspension for the CT imaging market in Canada.  This developmentrepresents a significant transition for Voyageur from the developmentphase to the production phase, where the focus will change to scalingup to commercially viable volumes of SmoothX to supply the Canadianimaging market. Management estimates that t hese two milestones will likely speed up first commercialsales in Canada and the FDA filing for approval in theUS.

Voyageur continues to advance thedevelopment and testing of four additional Health Canada approvedimaging products for sales in the Canadian radiology market. Voyageurcurrently holds Health Canada approval licenses for five bariumcontrast media products.

Brent Willis,Voyageur s CEO stated:“The completion of production testing for SmoothX and the scaleup tocommercial quantities to launch sales in Canada is an importantmilestone for the Company. It also marks a key point in our journey tocreate a fully integrated Canadian supply chain for barium contrastmedia. It also supports Canada s nationalstrategy of de-coupling from China for the supply of critical mineralsand critical pharmaceutical production. Basing our production testingon FDA protocols will advance our preparation for a generic drugsubmission to the FDA for the approval of SmoothX for gastrointestinalimaging. We have been engaged with the FDA on the path to approval forSmoothX since earlier this year and are now formally in contact withthe FDA s Office ofGeneric Drugs regarding the specific requirements of approval forSmoothX.”

In preparation for a generic drug submission to the USFDA, Voyageur has produced the recent batch in a manner that adheresto the Company’s FDA and Health Canada compliant quality managementsystem. This system has been implemented to ensure that a consistentand high-quality product is delivered to Voyageur's customer base. Theproduct batch that has been produced will be scaled up and, aftercompletion of 180 days stability tests, will be submitted to the FDAas part of the application process for approval of SmoothX for sale inthe United States market. This submission is expected to occur in thesecond quarter of 2023.

The Company contract manufacturer (CMO) of its's bariumcontrast media product line recently received their FDA siteregistration, an important step for the Company’s plan to penetratethe US market. Subject to financing, the Company continues to advancetowards the construction of its own certified pharmaceuticalmanufacturing facility. The Company has completed the feasibilitystudy and facility design phase and is currently finalizing thecapital plan. In the interim, the Company will continue itsrelationship with its CMO for production and testing of its imagingproducts for sale into the Canadian and US markets.

About Voyageur

Voyageur is a Canadian public company listed on theTSXV under the trading symbol VM. Voyageur is focused on thedevelopment of barium and iodine Active Pharmaceutical Ingredients(“API”) and high-performance cost-effective imaging contrastagents for the medical imaging marketplace. Voyageur’s goal is tofully integrate the barium and iodine contrast market by producing itsown minerals of barium and iodine. The business plan is to initiallygenerate cash flow from operations using third party GMPpharmaceutical manufacturers in Canada and validate the products forregulatory agencies globally. Then transitioning into a high margindomestic manufacturer of radiology drugs. Voyageur has plans to buildcarbon neutral infrastructure to become 100% self-sufficient acrossall manufacturing activities. Voyageur owns a 100% interest in threeCanadian barium sulphate (barite) projects including the Frances Creekproperty, suitable in grade for the pharmaceutical marketplace, withadditional interests in a high-grade iodine, lithium & brominebrine project located in Utah, USA. Voyageur is moving forward withits business plan of becoming the only fully integrated carbon neutralcompany in the radiology contrast media drug market, by controllingall primary input costs under the motto of:

"From the Earth to theBottle".

For Further MediaInformation or to set up an interview, please contact:

BrentWillis

AlDeslauriers

President &CEO

CFO

E brent@vpharma.ca

E albert@vpharma.ca

www.voyageurpharmaceuticals.ca

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: successfullytransitioning to the production phase; successful completion of theFDA approval process; submission of the batch to the FDA in the secondquarter of 2023; and financing. 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.

Copyright (c) 2022 TheNewswire - All rights reserved.

Stock Information

Company Name: Voyageur Pharmaceuticals Ltd.
Stock Symbol: VM:CC
Market: TSXVC
Website: voyageurpharmaceuticals.ca

Menu

VM:CC VM:CC Quote VM:CC Short VM:CC News VM:CC Articles VM:CC Message Board
Get VM:CC Alerts

News, Short Squeeze, Breakout and More Instantly...