OTTAWA, ONTARIO–(Marketwired – Mar 6, 2018) – Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation”) (TSX VENTURE:TBP)(OTCQB:TBPMF) announced today that its partner PS Innovations will be seeking CE Marking for its Rx Princeps™ Inhalation Device, thereby opening the door to Tetra’s commercialization efforts in Europe.
Tetra’s development and manufacturing partner, PS Innovations, will be seeking CE Marking for Tetra’s Rx Princeps™ Inhalation Device, which is used in conjunction with a dried loose cannabis, such as Rx Princeps™, to provide relief for advanced cancer pain and non-cancer pain patients.
Rx Princeps™ is a unique blend of 3 strains of medical cannabis. Its production has been standardized in order to ensure a lot-to-lot consistent composition in its active ingredients (THC and CBD). Rx Princeps™ is composed of the same medical cannabis blend used to produce PPP001, the lead product in Tetra’s pipeline of five cannabinoid-based prescription drugs seeking Health Canada and FDA approval in Canada and the United States.
“CE marking” is the process that guarantees a product’s conformity to the European regulations and is required to allow Tetra to commercialize and trade on the European and European Economic Area markets. Under the European regulation, Rx Princeps™ Inhalation Device will be considered as a Class 1 Medical Device.
“This is significant for Tetra since there are a number of European countries, with Germany at the forefront, where medical cannabis has been legalized,” said Bernard Fortier, Tetra’s CEO.
The annual potential estimate for the medical cannabis European market value is EUR35.7b, according to the European cannabis report from a Prohibition Partners November 2017 report. In the US, the consumption devices market grew 116.5% in 2016 (year over year growth, New Frontier data report 2016).
“We know that more than half the people who consume cannabis choose to smoke it,” said Mr. Fortier. “This first step into Europe with a strong partner like PS Innovations solidifies our strategic focus on global expansion and potentially offers the European medical community and their patients the most innovative therapeutic options.”
PS Innovations will ensure that the Rx Princeps™ Inhalation Device meets all the relevant Essential Requirements of the European Medical Device Directive and then register the product with the Competent Authority and affix the CE marking.
About PS Innovations:
PS Innovations was created in 2017 to bring new devices for the use of Cannabis products, and the creation of machinery dedicated to the manufacture of Cannabis based dosage forms. Current devices on the market today are designed for the use of tobacco, and not cannabis derived products. Cannabis is unique in many ways, and does not always behave in the manner that tobacco products do. PS Innovations has been able to bring to the market a Class I medical device, namely an inhalation device (pipe) specific to the ACMPR [Access to Cannabis for Medical Purposes Regulations] use of dry loose cannabis.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 Corporation 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 Corporation’s ability to control or predict, that may cause the actual results of the Corporation 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, failure to obtain sufficient financing to execute the Corporation’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Corporation’s research strategies, 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 Corporation’s public disclosure record on file with the relevant securities regulatory authorities. Although the Corporation 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Corporation 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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
1 (438) 899-7575