- Health Canada has re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a Class 2 Medical Device
- The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care
- Significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans
ORLEANS, Ontario, Sept. 13, 2018 – Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that Health Canada has re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a Class 2 Medical Device. The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care. The significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans. Tetra Bio-Pharma is undertaking a Phase III trial with PPP001 treating late stage cancer patients looking to improve quality of life and reduce pain. The Company also recently announced it is starting a head to head trial to investigate cannabis versus Fentanyl in managing breakthrough cancer pain.
“We are very excited by the reclassification as we believe it will provide patients with a financial benefit in terms of coverage for the device and prescription drug,†stated Dr. Guy Chamberland, Ph.D., Interim CEO and CSO at Tetra Bio-Pharma. “Many cancer patients rely on private and public insurance plans for access to their medication. This decision by the Government of Canada is an important step forward to facilitating access to cannabis drugs. This coupled with our robust clinical trial program and the evidence we are establishing will support physicians in discussing and recommending this option with their patients.â€
Dr. Chamberland further stated, “the lack of scientific data on the safety and efficacy of cannabis is a critical barrier to patient access, and something that Canadian physicians are waiting for before being comfortable to prescribe it. Equally essential is adhering to the highest standards of drug manufacturing as well as the production of the delivery mechanism – something that Tetra is committed to. There are more than 300,000 registered users of medical cannabis in the country and we can only expect this number to rise.â€
Tetra has been a pioneer in the development of several cannabis drugs. To date, the Corporation has completed several safety and pharmacokinetic studies in healthy volunteers obtaining proper dosing information and a clear understanding of the potential cardiovascular and neurological risks to patients. This information is critical to protect public health, and Tetra Bio-Pharma is engaged with Health Canada to comply with the highest drug safety standards.
About Tetra Bio-Pharma Inc.
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, 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
Source: Tetra Bio-Pharma
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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 approval of PPP001, insurance coverage for products being developed, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, 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. 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 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.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]
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