InvestmentPitch Media Video Discusses Voyageur Pharmaceuticals’ Completed Production of a Test Batch of its SmoothX™ Barium Sulfate CT Contrast Media Oral Suspension for the Canadian CT Imaging Market

Rhea-AI Summary

Voyageur Pharmaceuticals (TSXV:VM) (OTCPink:VYYRF) has successfully completed a test batch production of its SmoothX™ barium sulfate CT contrast media for the Canadian market. This transition indicates a shift from development to production, allowing for scaling to commercially viable volumes. The company aims for commercial sales in Canada and FDA filing in the US by Q2 2023. Voyageur has developed nine barium contrast media products, holding licenses for five, while working on FDA compliance for SmoothX. The contract manufacturer has received FDA registration, aiding US market entry.

Positive

• Successful completion of a test batch for SmoothX, indicating readiness for commercial production.
• Plans to file for FDA approval, with a target submission in Q2 2023.
• Possession of licenses for five imaging products from Health Canada.
• Contract manufacturer has received FDA site registration, facilitating US market entry.

Negative

• None.

VANCOUVER, British Columbia, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Voyageur Pharmaceuticals (TSXV:VM) (OTCPink:VYYRF) has completed production of a test batch of its SmoothX™ barium sulfate CT contrast media oral suspension for the CT imaging market in Canada. This production represents a significant transition for Voyageur as it moves from the development phase to the production phase, with the company now focusing on scaling up to commercially viable volumes of SmoothX to supply the Canadian imaging market.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

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Management expects that these two milestones will expedite the launch of the first commercial sales in Canada and the FDA filing for approval in the US. Voyageur has developed nine barium contrast media products for sale into the Canadian radiology pharmaceutical market and holds licenses from Health Canada for five of the imaging products, including SmoothX, while continuing to advance the development and testing of the remaining four products.

Brent Willis, CEO, stated: “The completion of production testing for SmoothX and the scaleup to commercial quantities to launch sales in Canada is an important milestone for the Company. It also marks a key point in our journey to create a fully integrated Canadian supply chain for barium contrast media. It also supports Canada’s national strategy of de-coupling from China for the supply of critical minerals and critical pharmaceutical production. Basing our production testing on FDA protocols will advance our preparation for a generic drug submission to the FDA for the approval of SmoothX for gastrointestinal imaging. We have been engaged with the FDA on the path to approval for SmoothX since earlier this year and are now formally in contact with the FDA’s Office of Generic Drugs regarding the specific requirements of approval for SmoothX.”

In preparation for a generic drug submission to the US FDA, Voyageur has produced the recent batch in a manner that adheres to the company’s FDA and Health Canada compliant quality management system, which was implemented to ensure that a consistent and high-quality product is delivered to Voyageur's customer base. The product batch that has been produced will be scaled up and, after completion of 180 days stability tests, it is expected they will be submitted to the FDA in the second quarter of 2023, as part of the application process for approval of SmoothX for sale in the United States market.

The company’s contract manufacturer (CMO) of its barium contrast media product line recently received their FDA site registration, an important step for the company’s plan to penetrate the US market. Subject to financing, Voyageur continues to advance towards the construction of its own certified pharmaceutical manufacturing facility and has completed the feasibility study and facility design phase and is currently finalizing the capital plan.

The sterile, carbon neutral, GMP manufacturing facility, designed to produce revenue streams from pharmaceutical barium and iodine contrast media products, is expected to produce additional revenues from industrial barite sales and will produce carbon fullerene allotropes for a new drug development program. In the interim, the Company will continue its relationship with its CMO for production and testing of its imaging products for sale into the Canadian and US markets.

Voyageur is focused on the development of both barium and iodine Active Pharmaceutical ingredients and high-performance cost-effective imaging contrast agents for the medical imaging marketplace.

These contrast materials, which may be taken orally or rectally, are used to improve pictures of the inside of the body helping to distinguish or “contrast” selected areas of the body from surrounding tissue allowing the radiologist performing imaging functions such a fluoroscopy, CT scans, and MRI’s, to distinguish normal from abnormal conditions.

The world is currently facing a contrast media shortage as a significant amount of iodinated contrast media is supplied from Shanghai, China which has suffered from shut-downs as a result of COVID-19 and more than 50 million diagnostic imaging examinations using contrast media are conducted annually.

The company owns a 100% interest in three barium sulphate (barite) projects including the Frances Creek property, suitable in grade for the pharmaceutical barite marketplace, with additional interest in a high-grade iodine, lithium & bromine brine project located in Utah, making the company unique, as it sources its main ingredients from its own mineral deposits.

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.”

The shares are currently trading at $0.075. For more information, please visit www.VoyageurPharmaceuticals.ca, contact Brent Willis, President and CEO, by email at brent@vpharma.ca, or Al Deslauriers, CFO, at albertl@vpharma.ca.

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FAQ

What recent production milestone did Voyageur Pharmaceuticals achieve with VYYRF?

Voyageur Pharmaceuticals completed a test batch of its SmoothX™ barium sulfate CT contrast media, marking a transition to production.

When does Voyageur Pharmaceuticals plan to submit for FDA approval for SmoothX?

The company plans to submit for FDA approval in the second quarter of 2023.

What are Voyageur Pharmaceuticals' licenses from Health Canada?

Voyageur holds licenses from Health Canada for five imaging products, including SmoothX.

How will Voyageur Pharmaceuticals penetrate the US market?

The company is advancing towards FDA approval and has a registered contract manufacturer to facilitate entry into the US market.

What is the significance of the recent FDA site registration for Voyageur Pharmaceuticals' manufacturing partner?

The FDA site registration is crucial for Voyageur's plan to enter the US market for its barium contrast media.