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Land | Danmark |
---|---|
Lista | First North Denmark |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
STENOCARE A/S
NASDAQ FIRST NORTH GROWTH MARKET, DENMARK
TICKER: STENO
STENOCARE A/S ("Stenocare") today announces their new innovative product-line is ready for the market - six months ahead of expectation. The new Astrum brand is an innovative cannabis oil product featuring a patented oil technology that enhances the bioavailability of its active ingredients. This breakthrough allows for higher uptake in the blood, and reduced dosage requirements. The first Astrum product will be launched for patients in Australia during Summer 2024.
Ahead of plan: Stenocare has since 2019 been investing with partners to develop and test next generation medical cannabis oil products, that can position Stenocare as a true leader within prescription-based medical cannabis. The new product-line is branded "Astrum", and the company has worldwide exclusivity for this patented oil technology. The company is now ready to commercialize the first market during Summer 2024 in Australia. The first product is Astrum 10-10 oil Stenocare, with 10 mg/ml THC and 10 mg/ml CBD.
Innovative product: The Stenocare Astrum product is based on an innovative oil technology, that has the potential to increase the cannabinoid's bioavailability in the patient's blood. Thereby, the new product is addressing a well-known challenge with dosing medicine and securing consistent uptake of the active ingredients in the blood. With the Astrum product, Stenocare has completed a pharmacokinetic (PK) study in dogs that documented two important parameters in the lymphatic system that can improve the bioavailability:
Parameter 1 - uptake in the blood: According to the PK-study, Astrum improves uptake in the blood with a factor 2.6 - compared to a reference MCT-oil product in the market. Low and inconsistent uptake of the drug in the blood across patients is a well-known challenge in the pharma industry, that applies to most drugs. This also applies to medical cannabis. Today, when patients are administrating traditional MCT-oil based medical cannabis, the metabolism will reduce the uptake of cannabinoids in the body. This means that a highly variable and often little part of the active ingredients (ie. cannabinoids) are delivered inside the patient with a therapeutic effect. This is creating problems to prescribe a steady dosage of the drug to patients. Also, the uptake in the blood is very different for each individual due to biological differences between patients. The new Astrum product is mitigating these challenges and offering higher bioavailability.
Parameter 2 - time to max effect: According to the PK-study, the Stenocare Astrum product improves time from dosing to max effect from 2-4 hours to just 1 hour, and offer's a more uniform experience. Predictability of uptake and time to max effect is important when doctors prescribe medical cannabis and when patients use it to treat their symptoms. The time to max effect is the duration of time it takes to reach maximum concentration of the drug in the blood after dosing the drug to the individual. Reaching the maximum as fast as possible is important to help patients manage their symptoms.
Commercializing the next generation product: The Stenocare Astrum product is the next generation product, that offers better predictability and uniformity for prescribers and for patients. The new product is protected with a patent and Stenocare is the first company to launch a prescription-based medical cannabis oil product with a lymphatic targeting technology. The commercial stage is now ready to begin, and Stenocare will work with their local partners in Australia to educate prescribers and collect feedback from the market.
Stenocare also has the ambition to launch the new product in several additional markets and hope the next commercial launch will happen during 2H 2024 - pending regulatory approvals from the local medicine agency.
Thomas Skovlund Schnegelsberg, CEO of Stenocare comments: "In our opinion, the new Astrum product is truly groundbreaking for the entire industry of medical cannabis and for the patients globally. In short, our new oil technology address key challenges in the industry of medical cannabis: 1) It doubles the uptake of cannabinoid, 2) It delivers a uniform uptake in the blood across individuals, 3) the maximum concentration of the drug is reached in half the time, and, finally, 4) it can be delivered in the body with a higher uniformity regardless of food consumption. Even though bioavailability has been a key challenge for a long time in the medical cannabis industry, it is our experience that real data from a pharmacokinetic study regarding the topic has not been available with a commercially available product. This puts Stenocare in a very strong position to be a first-mover in the next generation of medical cannabis oil products".
Path from development to market launch: The findings from the PK-study was announced on September 20, 2022 - which described the potential of the Astrum oil technology. Then Stenocare announced on June 2, 2023 - that an experienced manufacturer was found to produce the new Astrum products. It was expected that the first product would become commercially available during 2024. Since that announcement, the parties have been working hard to source the ingredients and testing production procedures for the new Astrum oil product. The process for having the product approved for sales has successfully been completed, and Stenocare is waiting for the last export certificate that will allow shipment of the new product into Australia. The market launch is expected during Summer 2024.