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2021-10-22

DanCann Pharma A/S: Tetra Bio-Pharma Receives Positive Opinion for Orphan Drug Designation for QIXLEEF™ from the European Medicines Agency

COPENHAGEN, Denmark, 22 October 2022, DanCann Pharma A/S ("DanCann Pharma"), a Danish company powered by cannabinoids, hereby on behalf of Tetra Bio-Pharma Inc. ("Tetra" or the "Company"), announce that Tetra Bio-Pharma - a leader in cannabinoid-derived drug discovery and development - yesterday announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company's application for Orphan Drug Designation (ODD) for its investigational medicine QIXLEEF™ as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition. 

DanCann Pharma signed 05 May 2021 a definitive distribution agreement with Canadian Tetra Bio-Pharma Inc. concerning the exclusive distribution of the cannabinoid-based medicines Reduvo™ Adversa® and Qixleef™ in Denmark, Norway, Sweden, Finland, and Germany. This press release is passed on from Tetra's own press release, concerning that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company's application for Orphan Drug Designation (ODD) for its investigational medicine QIXLEEF™ as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition. 

Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma said "the positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe.  An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the Company to easily gain market shares in a competitive free environment. If granted, this would represent QIXLEEF™'s second ODD as a potential treatment for CRPS, in addition to the ODD granted by the U.S. FDA in March 2018. We firmly believe that QIXLEEF™ will be a safe and effective medicine for pain management and an alternative to opioids."

The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days. The Committee based its opinion on Article 5 of Regulation (EC) No 141/2000 of 16 December 1999. The COMP based on majority of 30 out of 31 votes concluded that QIXLEEF™ satisfies the criteria for such designation and recommends the granting of orphan medicinal product designation.

The COMP determined that QIXLEEF™ qualifies as an orphan drug for CRPS indication as 1) the medicinal product is intended to treat a chronic debilitating condition, 2) the estimated prevalence of this rare condition is 4.4 in 10,000 persons in the European Union, and 3) available data from published literature shows improvement in peripheral neuropathic pain in patients treated with cannabinoid-based medicinal products.

The EMA grants orphan drug designation to encourage the development of drugs intended to treat rare and life-threatening diseases and therefore provides incentives to sponsors, such as protocol assistance, a specific type of Scientific Advice that allows the Agency to address sponsors' questions pertaining to clinical trials. Moreover, since QIXLEEF™ will be intended to treat an orphan condition, clinical studies will be preformed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralized procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval. Furthermore, once approved the drug will be eligible to 10 years of market exclusivity. Tetra Bio-Pharma would also benefit from reduced regulatory fees and administrative and procedural assistance.

About QIXLEEF™

QIXLEEF™ is a botanical inhaled drug product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The product will be first indicated in patients with cancer suffering from uncontrolled breakthrough pain (REBORN© trials) then in patients with advanced cancer with inadequately controlled pain (PLENITUDE© trials). QIXLEEF™, with its innovative and proprietary dosing data, provides fast acting relief from pain, offering patients a viable, safer, and non-opioid option for pain management.

About Complex Regional Pain Syndrome

Complex Regional Pain Syndrome is an uncommon condition that is affecting approximately 4.4 in 10,000 persons in the European Union and where patients experience persistent severe and debilitating pain, muscle spasticity, swelling, tremors, and weakness. The cause of CRPS is not completely understood, but the condition is thought to be caused by an injury to or an abnormality of the peripheral and central nervous systems. Cannabinoid-mediated therapy can provide analgesic effect, improve sleep, reduce anxiety and depression as well as relieve pain, which makes QIXLEEF™ well-suited as a potential therapy for CRPS.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

SOURCE Tetra Bio-Pharma Inc.

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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