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Publicerat: 2022-02-09 09:00:00

DanCann Pharma A/S: DanCann Pharma A/S has submitted application to the Danish Medicines Agency for EU-GMP-approval for Biotech Pharm1

COPENHAGEN, Denmark, 9 February 2022 – DanCann Pharma A/S (SS: DANCAN) ("DanCann Pharma" or the "Company"), a Danish company powered by cannabinoids, hereby announce that the Company submitted its application for EU-GMP-approval to the Danish Medicines Agency.

In April, DanCann Pharma pressed the start button in the Company’s first production facility, Biotech Pharm1 in Ansager. Now the Company is ready to be inspected from the Danish Medicines Agency in order to be approved according to EU-GMP standards. The approval is expected to be in place by the half year of 2022.

Biotech Pharm1 is built on best practices from the pharmaceutical industry in combination with advanced environmentally controlled manufacturing technology and vertical cultivation. This means that the selected geneticists are developed in multi-storey systems without the use of soil or other media, but with a specially developed system that adds the required amount of fluid and nutrients.

Morten Martinsen, COO of DanCann Pharma, comments:

I am very happy to announce that DanCann Pharma has submitted its application for our EU-GMP-application on Biotech Pharm1. This is another step in the right direction on the journey for DanCann Pharma – something we have been working towards for a really long time and we are looking forward to finally having the approval from the Danish Medicines Agency later in the year. DanCann Pharma and its first facility, Biotech Pharm1, are currently in the process of transforming from a project to an actual operation, which is very gratifying.

Jeppe Krog Rasmussen, CEO of DanCann Pharma, comments:

The EU-GMP certification of the facility is a hallmark of our work, and ultimately a hallmark of our processes and systems meeting requirements for the production of medical cannabis in Denmark and Europe. This as a step on the way to achieving quality assured products for partners, and ultimately patients, which is essential for the Company’s legitimacy to the market.

Uniform product content and a focus on delivering the same quality from time to time is a guarantee that DanCann Pharma is obliged to give to patients who can benefit from a treatment with medical cannabis and cannabinoids. DanCann Pharma was established to make a difference for patients, and we will never compromise on that.

Following the approval of the production conditions, DanCann Pharma faces its biggest milestone to date when the first batch of biomaterial is ready for delivery in the second half of 2022 from Biotech Pharm1.

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.

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

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