Food and Drug Administration confirms nonclinical and manufacturing requirements
ORLEANS, Ontario, Oct. 11, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced it received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for PPP002, its dronabinol AdVersa™ mucoadhesive product. The meeting was held to confirm that the proposed chemistry and manufacturing and non-clinical development plan for PPP002 for the 505(b)(2) is acceptable.
The FDA established that Tetra Bio-Pharma’s proposed bridging strategy fulfilled all the requirements of the 505(b)(2) regulatory pathway for the product PPP002. The FDA also provided feedback on the chemistry and manufacturing aspects of the drug development plan. The FDA further confirmed that the product control strategy, ensuring the identity, potency, purity and quality of the PPP002 buccal tablets was acceptable thereby determining that Tetra Bio-Pharma’s plan is on track for drug approval.
“We have now completed our meetings with the U.S. FDA and Tetra is well on its way to finalizing the development plan to bring PPP002 to market,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “With both the Type B and C meetings now behind us, we are able to move forward with executing the clinical program for PPP002 and subsequently submit the New Drug Application to commercialize PPP002.”
Tetra, along with its partner IntelGenx Corp, is developing this product in the United States under the accelerated 505(b)(2) pathway for the indication of chemotherapy-induced nausea and vomiting, and anorexia and weight loss in people with AIDS. These are the same indications that have already been approved for Marinol®. The 505(b)(2) speciality Contract Research Organization, Camargo, is guiding the regulatory submissions to the FDA. Tetra is also developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain.
According to the International Agency for Research on Cancer, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US $1.88 billion by 2020, an increase from its 2013 valuation of US$1.28 billion. Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that AdVersa™ can gain significant market share within three years of its launch in the USA.
A bout 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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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 PPP002, 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.
Executive Vice-President Corporate Development and Licensing
|Carol Levine||Stephanie Engel|
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Source: Tetra Bio-Pharma Inc