Please disregard original release sent out and replace with the following.
Tetra is accelerating its European activities
Tetra's European project receives the approval and support from Malta Enterprise
OTTAWA, ON / ACCESSWIRE / August 6, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that the Corporation is set to accelerate its European activities. The Corporation has received support from Malta Enterprise and will be creating a subsidiary in Europe to expand its clinical and regulatory activities as well as its future commercial operations for QIXLEEF™, in Europe. Malta Enterprise, the national economic development agency of the Government of Malta, has supported the launch of the project of Tetra in Malta, and is now also working together with our team to implement this project.
In Q4 2020, Tetra will open its European office in Malta. The jobs created in Malta will offset consultant and other associated costs. Dr. Guy Chamberland, CEO and CRO stated "We are extremely pleased that our European expansion project has received the approval and support from Malta Enterprise. It is anticipated that this support will allow Tetra to quickly and efficiently launch QIXLEEF™ in the five Major European Markets, notably Germany, France, Spain, Italy and the UK."
The Malta-based activities will involve regulatory filings with the European Medicines Agency (EMA) for all of Tetra's investigational new drugs and European-based clinical trial operations. This includes accelerating the Marketing Authorization Application (MAA) for QIXLEEF™ in Europe and performing a Phase 3 Plenitude© trial, as detailed in the May 2020 supplemental filing and overnight financing.
Tetra had a first meeting with the Malta Medicines Authority, which was facilitated by Malta Enterprise, and resulted in clarifications and identification of the milestones to complete a clinical trial application compliant with the requirements of the local and European Authorities. Tetra intends to submit the Plenitude© clinical trial as a Phase 3 study in Q4 2020 as the first step in initiating a clinical trial program in Malta. This trial will be performed in Europe to expand the claims associated with the prescription of the medicinal product QIXLEEF™. The Corporation is advancing its MAA filing strategy in Europe and will continue regulatory discussions with the Malta Medicines Authority.
Dr. Guy Chamberland, CEO and CRO commented, "The decision to choose Malta was simple. Our scientific and regulatory team recognized and appreciated the professionalism and guidance from Malta Enterprise and the Malta Medicines Authority. Furthermore, Aphria's ARA-Avanti Rx Analytics, the Aphria One facility in Canada, and its subsidiary, ASG Pharma Ltd. which is based in Malta, have all received European Union Good Manufacturing Practices (EU-GMP) certification from the same Competent Authority (Malta Medicines Authority) for the production of cannabis, which will allow for a pharmaceutical GMP compliant trial. These certifications include cannabis flower supply, processing the flower into finished goods, to the ability to ship finished dried flower throughout the European Union. Aphria's GMP quality system will enable Tetra to meet its European market objectives including the ability to perform a Phase 3 trial. The Plenitude© trial is designed to prove the efficacy and safety of QIXLEEF™ for the relief of pain in cancer patients. These pain claims will allow expansion of the market size for QIXLEEF in Europe."
"We are pleased to have partnered with Tetra in the development of QIXLEEF™. Since 2014, Aphria has been a leading, trusted choice for Canadian patients seeking high quality pharmaceutical-grade medical cannabis and, today, our EU-GMP certified operations will allow Tetra to expand its drug development and commercial activities to Europe," said Denise Faltischek, Chief Strategy Officer, Aphria, Inc.
Kurt Farrugia, CEO of Malta Enterprise commented, "Malta is placing the areas of life sciences and particularly research and development at the forefront of its foreign direct investment efforts. We welcome the addition of Tetra to Malta's portfolio. Malta Enterprise is delighted to support Tetra to set up its European office in Malta and carry out significant value adding activity to our life sciences sector."
Dr. Guy Chamberland, added, "We will continue to keep shareholders informed as we progress with the commercial strategy for QIXLEEF™. We see tremendous value and potential for our botanical-based medicine. The recent financing allowed us to accelerate QIXLEEF™ to the market and we are pleased to provide our shareholders with an update."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
About Malta Enterprise
Malta Enterprise is the country's economic development agency, tasked with attracting new foreign direct investment as well as facilitating the growth of existing operations. In operation under various guises since the 1950s, which is almost since the beginning of Malta's industrial development, the Corporation contains within it a great deal of accumulated experience in the field. Furthermore, it acts as an adviser to government on economic policy due to its close and constant interaction with the main economic players in the country. Malta Enterprise is also the national contact point for the Enterprise Europe Network through which companies based in Malta can develop links with counterparts in over 60 other countries.
For more information visit: www.maltaenterprise.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
For further information, please contact Tetra Bio-Pharma Inc.:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma