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Tetra Bio-Pharma Receives Favorable Letter of Advice from USA FDA for QIXLEEF


FDA Feedback continues to support the development of QIXLEEF for second- or third-line therapy for adult patients with uncontrolled pain

FDA advice consistent with previous feedback paving the way for the marketing approval of QIXLEEF

OTTAWA, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced that it has received a favorable Letter of Advice from the US Food and Drug Administration for QIXLEEF.

“We are extremely excited to have received this letter from the FDA for QIXLEEF.  Once again, it demonstrates the FDA’s commitment to approve this botanical drug for chronic pain if the quality, non-clinical safety and human clinical data are positive.  This Letter of Advice clearly shows that QIXLEEF can be developed for chronic pain conditions beyond pain in patients with advanced cancer.  It also reconfirms FDA’s previous position on the development and commercialization of QIXLEEF for pain management including indications, such as second- or third-line therapy for uncontrolled cancer and non-cancer pain," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. 

On January 26, 2017, FDA had previously provided in-depth guidance to Tetra on the development of QIXLEEF (PPP001).  This Letter of Advice provides Tetra new guidance based on our clinical and safety progress with the quality of QIXLEEF and lays out the requirements for marketing approval (i.e., approved for sale) for cancer and non-cancer pain indications.  "FDA collaboration has been excellent and continues to show that Tetra develops prescription drugs in accordance with FDA regulatory standards, in place for pharmaceutical products," commented Dr. Chamberland.

According to Allied Market Research (reference), the global drug market for pain management was about $60 billion in 2016 and is estimated to reach $130 billion by 2023.  This includes pain medications for indications such as Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Back Pain, Postoperative Pain, Migraine, and Fibromyalgia.

First line pain medications include acetaminophen and NSAIDs whereas second- and third-line drugs include Lyrica, Cymbalta and opioids.  Chamberland added, "With this letter we are confident that we can develop QIXLEEF for pain indications beyond cancer.  Indeed, QIXLEEF can be developed all the way to an indication for use as a second- or third-line drug for use in pain relief.  Tetra will be continuing to develop QIXLEEF for advanced cancer pain but will now evaluate the best market opportunity within this large potential multi-billion dollar market of second- or third line pain medications.  If clinical trials are successful, this will significantly shift the opioid battle." 

Pain Management Drugs Market by Drug Class (NSAIDs, Anesthetics, Anticonvulsants, Antimigraine Agents, Antidepressants, Opioids [Tramadol, Hydrocodone, Oxycodone, and Others], and Nonnarcotic Analgesics) and Indication (Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Back Pain, Postoperative Pain, Migraine, and Fibromyalgia) - Global Opportunity Analysis and Industry Forecast, 2017-2023

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. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.

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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.

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.

For further information, please contact Tetra Bio-Pharma Inc.:

Investor Contact:
Bruce Mackle
LifeSci Advisors LLC

Media Contact: 
Andrew Mielach
LifeSci Public Relations


Carol Levine 
Energi PR 
514-288-8500 ext. 226 


Source: Tetra Bio-Pharma

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