Semaglutide - Ozempic(R) is Chemically Stable When Administered Using NuGen's Needle Free InsuJet(TM) Device

October 10, 2023 5:15 PM EDT | Source: NuGen Medical Devices Inc.

Toronto, Ontario--(Newsfile Corp. - October 10, 2023) - NuGen Medical Devices Inc. (TSXV: NGMD) (the "Company" or "NuGen") a leading developer of needle free devices to administer therapeutics subcutaneously, today presented new data from a preliminary trial that semaglutide (Ozempic®) is chemically stable after it is administered through NuGen's InsuJet™ needle-free injection device.

"Today's discovery paves the way for future tests to validate the findings and prepare for the rigors of regulatory assessments as we move forward and build on this positive result," commented Dr. John Leombruno, Independent Director. "Semaglutide is the first of many licensed agents to be tested using the InsuJet™ device. Our goal is to create a pipeline of injectable agents that have high sales volume and are suitable for needleless injection with InsuJet™ so that we can partner with manufactures to offer needle free versions of the most common biosimilars."

NuGen first announced on April 10th, 2023, it had engaged Basic Pharma Technologies in the Netherlands to preform an assessment and feasibility study, including validation testing of semaglutide if administered using NuGen's needle free injection.

Laboratory results received on October 5th, 2023, from Basic Pharma showed no differences were detected between the use of the Ozempic® pen and the InsuJet™ needle free device. Specifically, commercially available Ozempic® was loaded into and discharged from the InsuJet™ device and compared to the liquid discharged from the commercially available Ozempic® pen. No degradants were detected from the use of the InsuJet™ device via HPLC (High-Performance Liquid Chromatography) analysis of the liquid.

Dr. John, Leombruno, Independent Director

John Leombruno has executive level experience in many areas of the pharmaceutical industry, including market access, medical information, pharmacovigilance, medical affairs, and business development. He co-founded Patient Direct (a patient support and specialty pharmacy provider) and GMD Distribution (a pharmaceutical distribution, patient support and specialty pharmacy services firm), both of which were acquired by McKesson Canada between 2010 and 2017. In 2019, John started OkRx, a Canadian Healthcare software company focusing on helping patients, prescribers, insurers, and pharmaceutical companies manage specialty medications. Dr. Leombruno is formally trained as a Pharmacist and has earned an MBA from Queen's University and a PhD in Pharmacoepidemiology from University of Toronto.

About Semaglutide / Ozempic®

Semaglutide is the drug known as Ozempic® and it is currently administered by a pen needle method. Semaglutide is a GLP-1 receptor agonist, meaning that it mimics the action of human incretin glucagon-like peptide-1 (GLP-1). This improves insulin secretion and glycemic control, and reduces appetite and calorie intake. It was developed by Novo Nordisk in 2012 as a longer-acting alternative to liraglutide, an insulin for type 2 diabetics but also for administration to obese patients and marketed under the trade name "Ozempic®." Ozempic® has recently come into the public eye, with numerous celebrities and influencers claiming to have lost weight with the drug. The result was product shortages[1], so that the levy was regulated in many places[2].

About Basic Pharma Technologies

Basic Pharma is an advanced, independent pharmaceutical company primarily engaged in the development, licensing, manufacture and commercialisation of pharmaceutical and biopharmaceutical products. Basic Pharma is a full service package to the pharmaceutical, biotech and medical device industry.

For more information, visit www.basicpharma.nl.

About NuGen

NuGen is a specialty medical device Company that is marketing and selling its next-generation InsuJet™ needle-free injection system designed to improve the lives of millions of diabetics. InsuJet™ is approved for sale in 42 countries around the world.

For further information, please visit:

Websites: www.insujet.com and www.nugenmd.com
Instagram: @NuGenMD
Twitter: @NuGenMD
LinkedIn: https://www.linkedin.com/company/nugenmd/

For further information, please contact:

Tony Di Benedetto
Executive Chairman
(416) 791-9399
tony@nugenmd.com

Richard Buzbuzian
President & CEO
(647) 501-3290
richard@nugenmd.com

To arrange a media interview with Nugen Medical Devices, please contact:

Morna Gorman
(416) 553-1732
morna@nugenmd.com

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accept responsibility for the adequacy or accuracy of this release.

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. These forward-looking statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The forward-looking information contained herein is given as of the date hereof and the Company assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.


[1] https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisks-diabetes-drug-ozempic-back-supply-after-months-shortage-2023-03-17/.

[2] https://www.cbc.ca/news/canada/british-columbia/ozempic-canada-british-columbia-1.6793114.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/183498

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