Tetra Bio-Pharma Receives Positive Opinion for Orphan Drug Designation for QIXLEEF™ from the European Medicines Agency

Rhea-AI Summary

Tetra Bio-Pharma announced a positive opinion from the European Medicines Agency (EMA) for its investigational drug QIXLEEF™ as a treatment for Complex Regional Pain Syndrome (CRPS). This opinion from the Committee for Orphan Medicinal Products (COMP) supports Tetra's application for Orphan Drug Designation (ODD), which can lead to a faster review process, reduced drug development costs, and market exclusivity for 10 years. This would be QIXLEEF's second ODD, following the FDA designation in March 2018. The company aims to provide a safer, non-opioid pain management solution.

Positive

• Positive opinion from EMA's COMP for QIXLEEF™ as a treatment for CRPS, indicating strong regulatory support.
• Orphan Drug Designation (ODD) could provide 10 years of market exclusivity, reduced fees, and an accelerated review process.
• Second ODD for QIXLEEF™ follows FDA's approval in March 2018, enhancing the product's credibility and market potential.

Negative

• None.

OTTAWA, ON, Oct. 21, 2021 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today 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.  

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

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements
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 a number of 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 and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, 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 news release are made as of the date of this news release 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.

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SOURCE Tetra Bio-Pharma Inc.

FAQ

What is the significance of the ODD granted to Tetra Bio-Pharma for QIXLEEF™?

The Orphan Drug Designation (ODD) allows Tetra Bio-Pharma to have a faster regulatory review, reduced development costs, and 10 years of market exclusivity for QIXLEEF™, a potential treatment for Complex Regional Pain Syndrome.

When was the positive opinion for QIXLEEF™ received from the EMA?

The positive opinion from the EMA was announced on October 21, 2021.

What condition does QIXLEEF™ target in its treatment?

QIXLEEF™ is aimed at treating Complex Regional Pain Syndrome (CRPS), a rare and debilitating chronic pain condition.

How does the ODD impact clinical trials for QIXLEEF™?

With Orphan Drug Designation, clinical trials for QIXLEEF™ can be conducted with fewer patients, potentially leading to conditional approval and faster market access.