CORRECTION FROM SOURCE - NEW RELEASE MENTION OF APHRIA 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."