DanCann Pharma A/S receives EU-GMP certification for its manufacturing facility Biotech Pharm1
COPENHAGEN, Denmark, 2 December 2022 - DanCann Pharma A/S (SS: DANCAN) ("DanCann Pharma" or the "Company"), a Danish company powered by cannabinoids, hereby announces that the Company will obtain its EU-GMP certification of its facility Biotech Pharm1 (“Biotech Pharm1” or the “Facility”) from the Danish Medicines Agency and subsequently admitted under the Danish Pilot Programme for the manufacturing of cannabis bulk.
At DanCann Pharma in Ansager the Danish Medicines Agency has successfully completed their inspection of the Company’s manufacturing Facility with no major deviations. The inspection was carried out over the days from Tuesday November 29 and Wednesday November 30, after which the Company was notified of the approval. This means that the Company with the EU-GMP certification in hand will be officially admitted under the Danish Pilot Programme with medical cannabis, where the Facility until now has been categorized under the Development Scheme, which is a section under the actual Pilot Programme. A formal report is being prepared, which the Danish Medicines Agency expects to forward to DanCann Pharma before the end of 2022.
The Company will now initiate its first commercial batches from the Facility, where the Company must work in parallel with its Product Quality Review (“PQR”), which is the validation of the first batches, so the Company can prove it can bring standardized products to market, manufactured under procedure and protocols, as well as within specification, and to do this over time - initially assessed on its first three (3) batches. This will ultimately form the basis for the Company being approved to release its products in May. This (the release of products) requires an additional inspection which is expected to take place in March/April 2023.
DanCann Pharma expects to ship its first batch to WEECO Pharma GmbH in May 2023.
Jeppe Krog Rasmussen, Founder and CEO, comments:
- The fact that we have managed to get the approval in the first attempt says a lot about the spirit of our company. We have been working towards this for the last 3-4 years, and to succeed in the first attempt is very gratifying. Through our history we have passed a number of milestones, but this is by far the most important. We are now one of a limited number of companies to have achieved this certification in our industry, which is quite satisfying.
- Now we have taken another step towards our commercialization, where sales from Biotech Pharm1 can become a reality. We will soon be able to achieve our guidance and goals with our commercial assets in the form of already signed agreements of more than DKK 80 million by 2025.
Morten Martinsen, Co-Founder and Head of Business Development, elaborates:
- A big and emotional day for all of us, this is the result of a huge amount of work that is now paying off. I'm incredibly proud of what we have achieved, and the approval is a result of a heroic effort from everybody involved. Our primary goal in DanCann Pharma is to help patients in need, and we are now an important step closer to being able to do this.
- We took over the abandoned Facilities in Ansager four years ago and started the construction of Biotech Pharm1 from scratch. Now we have a high-end EU-GMP-certified production facility and will be able to start producing biomaterial for delivery in 2023. The journey so far has been intense, tough and exiting, and we are definitely ready to take the next step in order to further develop DanCann Pharma.
About DanCann Pharma
DanCann Pharma A/S (SS: DANCAN) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids. DanCann Pharma is a vertically integrated, licensed production and distribution Company based in Denmark. The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.
DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen.
For more information, visit: www.dancann.com
For further information, please contact:
Jeppe Krog Rasmussen, CEO
E-mail: jkr@dancann.com
Website: www.dancann.com
This is information that DanCann Pharma A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on December 2, 2022, at 08:00 CEST.
Disclaimer
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.