DanCann Pharma A/S has signed an exclusive contract with MYCB1 GmbH for the distribution of full-spectrum extracts based on Bedrocan International varieties
DanCann Pharma A/S (SS: DANCAN) (OTCQB: DCPXF) ("DanCann Pharma" or the "Company"), a Danish company powered by cannabinoids, hereby announce that the Company and MYCB1 GmbH (“MYCB1”) has signed an exclusive distribution agreement to introduce MYCB1's portfolio of prescription-only medications based on cannabinoids and the ALETTA 2.0, a Real-World Evidence platform, in the Scandinavian markets, which have a combined population of approximately 21 million people.
MYCB1's prescription-only medications are manufactured by MYCB1 GmbH, a German pharmaceutical company based in Steinheim/Westphalia, that sources the raw material from Bedrocan International flowers, a Netherlands-based supplier of GMP grade medicinal cannabis.
MYCB1 GmbH is certified with Good Manufacturing Practice (GMP) by the European Medicine Agency and inspected by German authorities with Authorisation no. DE_NW_02_MIA_2022_0013 in accordance with Art. 40 of Directive 2001/83/EC. (see MYCB1.DE)
ALETTA 2.0 is an advanced Real-World Evidence tool for disease-specific studies and patient-reported outcomes. It allows for sophisticated studies in both real-world and controlled settings, providing valuable insights to inform clinical decision-making, improve patient care, and fill the gap in high-quality evidence for prescription-only cannabinoid treatments. The platform is GDPR-compliant and meets international information security standards, including ISO 27001:2017 and NEN 7510-1:2017 for the Dutch healthcare sector. More information on the certification and management system requirements can be obtained by contacting the certified organization, Brand Compliance, at www.brandcompliance.com.
The Company expects to initiate work with regulatory authorities once the current application (extracts of cannabis in an oil solution), which has been in process for a period, is completed and approved. The Company will receive the next feedback from the Danish Medicines Agency on this matter in mid-May 2023 followed by an update to the market.
Jeppe Krog Rasmussen, CEO of DanCann Pharma, comments:
“I am absolutely thrilled to announce our partnership with MYCB1. Their fully compliant GMP extracts are a game-changer in the market, and we are proud to offer them in an innovative new delivery format. We believe that these products have the potential to transform the landscape of medicinal cannabis treatment and bring hope to countless patients.
Due to our familiarity with Bedrocan as a manufacturer and supplier to the Danish market through our Company, we have great confidence that we will be able to successfully launch these products in the near future. This is due to the immense quality assurance provided by Bedrocan's GMP flowers and granules, which are then further processed in MYCB1’s GMP facility in Germany. To the best of our knowledge, these are the only fully compliant GMP extracts on the market (from plant to patient), providing immense peace of mind for both the users and prescribers.
Currently, we already distribute Bedrocan®, Bediol®, and Bedica® in flower and granular formats to Danish medical wholesalers and pharmacies. Now, we are excited to announce that we will be launching the same varieties in extract formats in the same markets. These extracts will be available in 3-5 different strengths when fully launched in the market, providing even more options for patients and healthcare providers.
Furthermore, we are super excited to announce that we plan to introduce Bedrolite® in the same extract format, as well as in a granular/flower version, in the near future. This will ensure access to quality-assured cannabidiol (read: CBD) treatment with a prescription.”
Jeppe Krog Rasmussen, elaborates further:
“Our collaboration with MYCB1 is not just about business; it's about a shared vision for a better future. We are committed to breaking down barriers and providing accessible, high-quality healthcare to all those who need it. Through our partnership, we are taking a significant step forward in achieving this goal.
We understand the impact that medicinal cannabis can have on patients' lives, and we are dedicated to ensuring that everyone has access to safe, effective treatments. Our partnership with MYCB1 and the ALETTA platform will allow us to connect with patients on a deeper level, empowering them to take control of their health and well-being.
This is not our first endeavour in this field of partnerships, as evidenced by our recent collaboration with pain specialist Tina Horsted and the entire Horsted Institute project, which has already yielded some strong results for the benefit of everyone.
Together with MYCB1, we can make a real difference in the world of medicinal cannabis. We are excited to embark on this journey with MYCB1 and are confident that our shared commitment to innovation and patient-centric care will lead to positive outcomes for all,” states Jeppe Krog Rasmussen, CEO of DanCann Pharma.
Ernesto Diringuer, CEO of MYCB1, comments:
"We are delighted to celebrate our distribution agreement with DanCann Pharma, a leading company that will introduce MYCB1 prescription-only medications out of Bedrocan flowers together with ALETTA in the Scandinavian markets, which have a combined population of approximately 21 million people. This will advance the state of evidence in prescription-only cannabinoid treatments.
This agreement is aligned with our mission of leveraging real-world evidence (RWE) and AI technology to make healthcare and lifestyle decisions data-driven and ultra-personalized.
The medicinal cannabis market has a larger projected market growth, but a low level of evidence. As a prescription medication already available in the market with potential use in many conditions and an acceptable safety profile, it is an ideal medication to evaluate in a real-world setting. This will serve as the foundation for the development of ALETTA as the world's most advanced technology in the RWE space, addressing complex issues due to the lack of high-quality evidence, such as off-label prescriptions, supplements, behavioural interventions, and alternative therapies.
And continues:
Our ultimate goal is to save lives, reduce costs, improve outcomes, and lay the foundation for personalized medicine worldwide.
It's important to note that regulatory bodies, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), prioritise the need for RWE,” said Ernesto Diringuer, CEO of MYCB1.
The Company's ambition is to gain market share from the current magistral market, which currently has a turnover of approximately DKK 7 million per quarter - with these extracts, there is a significant potential for disruption through increased competition and the introduction of highly standardized fully-GMP compliant products in various formulations.
About MYCB1 Group B.V.
MYCB1 Group B.V, founded in 2017 and with headquarters located in Amsterdam Science Park, is a health technology scale-up company that focuses on offering a diverse range of medications and services, including personalized options. Our innovative approach synergistically merges pharmaceutical manufacturing (MYCB1 GmbH), pharmacy operations (MYCB1 B.V), and cutting-edge software development to drive evidence-based, patient-centric healthcare solutions.
In conjunction, we are developing ALETTA, a cutting-edge digital personal assistant that actively helps users with ultra-personalized health recommendations. It harnesses the power of AI and real-world evidence (RWE) to address the endemic problem of poor scientific evidence and personalization in the healthcare and lifestyle industries, ultimately fostering evidence-based decision-making and optimizing individual health outcomes.
About DanCann Pharma A/S
DanCann Pharma A/S (SS: DANCAN) (OTCQB: DCPXF) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids. DanCann Pharma is a licensed production and distribution Company.
The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.
DanCann Pharma is EU-GMP-approved by the Danish Medicines Agency under the Danish Pilot Programme for medical cannabis, and have, among other things, license for manufacturing, export, import and distribution. The DanCann Pharma group also owns the subsidiary CannGros ApS, which is the market leader in Denmark with the import and distribution of the products Bedrocan®, Bedica® and Bediol® to all the Danish pharmacies.
DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen/Stockholm and side listed on OTCQB Venture Market in USA (OTCQB: DCPXF).
For more information, visit: www.dancann.com
For further information, please contact:
Jeppe Krog Rasmussen, CEO
Phone: +45 2963 6920
E-mail: jkr@dancann.com
Forward-looking-statement:
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events, or developments that the Company believes, expects, or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology.
Forward-looking statements are subject to several risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities.
Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this presentation are made as of the date of this presentation and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.