STENOCARE update on their strong Danish product pipeline

STENOCARE A/S NASDAQ FIRST NORTH GROWTH MARKET, DENMARK TICKER:  STENO STENOCARE A/S (“Stenocare”) is sharing the plans and work with their strong Danish product pipeline across its four stages from concept to commercialization. Meeting Danish Drug Standards (DLS) the company has a full product program of 2nd generation medical cannabis oil products (stage 3+4), specialized products with unique potency profiles (stage 2) and also 3rd generation product program that can revolutionize the industry (stage 1).

Since 2018, Stenocare has been the sole supplier of medical cannabis oil products for the Danish Pilot Programme. The company currently offers two prescription-based oil products (stage 4) for patients: a THC 30 mg/mL product and a CBD 20 mg/mL product. The company continuously analyse market opportunities and feedback from doctors to qualify the product pipeline and deliver on the mission to provide prescription-based medical cannabis products for treatment of patients.

When a product candidate has been identified, the company addresses several critical success parameters before venturing further with the development. Uncovering which patient indications can potentially be targets and treatment price points are important for defining the market opportunity. Then the company review the manufacturing capabilities internally and with its experienced partners. This is generally a collaborative process involving the supplier, distributors, physicians, and patients.

Denmark is both the Stenocare home market and a valuable test market for products. This is because the Danish Pilot Program and Danish Medicines Agency are leading the regulatory development for standardization of medical cannabis products, and because highly experienced medical specialists are sharing clinical information that is critical for developing the right product formulations. Having products approved for sales in Denmark has been a gateway for the Stenocare to enter other markets with its product portfolio.

Stenocare actively work with their product pipeline to meet needs from medical specialists and offer more choice for patients. The Danish Medicines Agency has a policy of only reviewing one product application at a time (stage 3), and therefore Stenocare carefully manage and prioritize the product pipeline from concept to commercialization in four stages.

STENOCARE pipeline stages:
Stage 1Stage 2Stage 3Stage 4
Concept stage: Defining product standards, specifications and manufacturing and release protocols.Validation process and stability testing. Establishing proof of concept, data collection to document regulatory compliance.Submission of application and approval process by Danish Medicinal Agency
  • Complete product documentation package that is compliance with Danish Drug Standards (DLS)Validation for completeness
  • Circular review process concerning regulatory and pharma-chemical topics
Commercial stage: Prescription based products availability for patients
STENOCARE product pipeline:
Stage 1Stage 2Stage 3Stage 4
New innovative product category based on a patented Lymphatic Targeting oil Technologyto create rapid uptake, greater absorption and thus efficacyVery high potency CBD OIL formulation, Ready for review for regulatory compliance by the by Danish Medicinal AgencyBALANCED OIL STENOCARE, currently due for review by the Danish Medicinal AgencyTHC OIL STENOCARE, since April 2022CBD OIL STENOCARE, since January 2023

As more pipeline products reach the commercial stage 4, this is expected to have a significantly positive impact on sales activities in Denmark. Especially the Balanced Oil product in stage 3 is expected to become a hero product – as this product formulation has historically represented +50% of sales volume. The speed of the process towards completion of stage 3 will depend on the Danish Medicines Agency's internal capacity, as they have faced delays in 2023 due to pressure on agency resources, making it challenging for them to meet their own timelines for reviewing applications.

The Stenocare track record for regulatory collaboration and structured work across the four pipeline stages, has created valuable assets for the company and trustworthiness with the health authorities in Europe. Stenocare is recognized as competent participant in the standardization process of medical cannabis extracts with the expert committee under the European Medicinal Agency, and also participating in the important work to evolve the European monography for medical cannabis.