This news release addresses the material aspects of the decisions taken by the FDA and implications of the guidance provided by the FDA. Tetra will provide information on the other decisions provided by the FDA as well as further elaborate on the implications of the material decisions once assessed by management.
The purpose of the Type B meeting was to obtain (1) confirmation of the eligibility of CAUMZ for Expedited Review programs Fast Track and Accelerated Approval, (2) clarification on the requirements for the medical device portion of the New Drug Application (“NDA“), (3) validation of the nonclinical safety program by indication (original NDA and supplement NDA), and (4) guidance on the study protocols that would be used to bring CAUMZ to the market.
Expedited Review programs Fast Track and Accelerated Approval
Fast Track is a designation granted by the FDA for expedited review of drug products which treat a serious or life-threatening condition and fill an unmet medical need. In its response, the FDA agreed that the target patient population has a serious condition with significant morbidity. Tetra’s clinical data to date has allowed management to make the assessment that CAUMZ will affect the survival of patients with an advanced cancer and affect their day-to-day functioning. If the disease of the target patient population is not treated with CAUMZ, their health and wellbeing will continue to deteriorate to a more serious condition. With regards to unmet medical need, this patient population does not respond to any available therapy and CAUMZ will provide an improved effect on a serious outcome of the condition. These are the basic requirements for eligibility to Fast Track and other Expedited Review Programs. The FDA agreed that the Company, meeting the conditions in the regulations, could now proceed to submit a Fast Track designation request to the review division. The FDA reviews the request and, in general, decides within sixty days.
The Fast Track designation reduces review time from an average of 10 months to 6 months which is critical to provide patients rapid access to new drugs. It also allows for frequent communications with the FDA which ultimately reduces the risk of delays by ensuring that all of the drug development issues are adequately addressed by the development program.
The FDA reviewed Tetra’s request that CAUMZ should qualify for Accelerated Approval (“AA“) for its target patient population. Accelerated Approval is a regulatory program for drugs, like CAUMZ, that are developed for the treatment of serious conditions in which the use of a surrogate endpoint is justified because the measured clinical benefit takes a long time to measure. Pain is directly measured using several validated pain scales and a drug being developed with an intended use of pain relief would not be eligible for AA. The FDA then provided guidance how Tetra could use a Patient-Reported Outcome (“PRO“) instrument that could demonstrate the claimed benefit in the target population.
Based on the FDA guidance, CAUMZ is a treatment intended for cancer cachexia patients with an advanced, incurable and malignant cancer that is refractory to treatment. CAUMZ is designed to prolong survival and improve quality of life and the patient’s day-to-day functioning. Tetra confirms that it will be using a validated surrogate endpoint that is a PRO instrument and that the Company will be moving ahead with the clinical development of CAUMZ based on the AA regulatory program.
The FDA stated that they had not previously approved a drug product with this specific intended use and provided detailed guidance on the development program. Dr. Guy Chamberland , CEO and Chief Regulatory Officer of Tetra stated “With this feedback from the FDA we are confident that we can develop QIXLEEF as botanical drug-device combination product for cancer and noncancer pain indications and that both products will be well differentiated from a medical point of view. This refinement of the intended use for CAUMZ does not affect the clinical trial patient population nor the clinical sites participating in the Serenity © clinical trial.
Combination Product Regulations & 505(b)(2) NDA Pathway
CAUMZ is the next generation of QIXLEEF that was created based on the intellectual property developed by the Company. The clinical development program of CAUMZ was designed to address a potential decision by the FDA that the medicinal component of the CAUMZ-kit was a drug-drug combination product. The FDA response stated that the CAUMZ drug component is a drug-drug combination product and that Tetra would have to address the interaction of these two drugs (specifically CBD and THC) in its clinical development program. The information package submitted for the Type B meeting contained how Tetra intended to address this interaction and the FDA provided detailed guidance on the approach.
Subsequent to the above decision, the FDA stated that Tetra had proposed a 505(b)(2) NDA in its Information Package, meaning that the Corporation’s NDA application could rely upon literature to support the nonclinical requirements of the NDA. The decision by FDA of the drug-drug combination product and the NDA 505(b)(2) approval pathway is favorable to Tetra.
Essentially, the 505(b)(2) pathway allows a corporation to avoid unnecessary duplication of studies already performed on a previously approved drug and it legally allows the FDA to rely on data not developed by Tetra. The 505(b)(2) type of NDA contains the complete safety and efficacy reports but allows that some of the data required for approval, such as safety and efficacy information on the THC and CBD drugs, to come from studies not conducted by Tetra. Dr. Guy Chamberland , commented “our shareholders may benefit from this decision as the 505(b)(2) results in a lower overall cost of development and faster route to marketing approval.” He added, “This pathway does not prevent Tetra from a Fast Track or Accelerated Approval. “
Chamberland added “Based on the FDA decisions and guidance, Tetra confirms that CAUMZ will be able to benefit from three regulatory decisions-programs: 505(b)(2) which will lower overall costs, Fast Track designation, and Accelerated Approval which may reduce the time to market.” With this feedback from the FDA, Tetra has two novel drug products that will be well differentiated from a medical point of view. QIXLEEF will continue to be developed as a drug-device combination product, benefit from the botanical aspects of the drug and be evaluated by the analgesic drug division. QIXLEEF is being developed for cancer and noncancer pain indications. CAUMZ will be developed as drug-device combination product with the drug component being a drug-drug combination product and it will be evaluated by the oncology drug division of the FDA. This prescription drug product is inline with Tetra’s mission to bring safe and efficacious alternatives to patients suffering from cancer or any chronic pain condition.”
About Tetra Bio-Pharma
Tetra Bio-Pharma (TBP.V) (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
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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 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.
SOURCE Tetra Bio-Pharma Inc.