OTTAWA, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (TSX-V) (OTCQB: TBPMF), a leader in drug discovery and development for cannabinoid-based therapeutics, today confirmed its regulatory strategy of its CAUMZTM (PPP011) inhalation drug product and provided additional updates on its progress with U.S. Food and Drug Administration (FDA) for an expedited review. Additionally, the company provided updates on its plans and preparations for commercial launch of CAUMZTM, which include the appointments of key strategic personnel.
“Tetra’s regulatory team has made tremendous progress and we are pleased to confirm our regulatory strategy of CAUMZTM. Our clinical development strategy to date has been aimed at addressing all of the requirements of the Food and Drug Act and obtaining FDA approval for CAUMZTM-Kit,” commented Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma Inc. "To that end, we have taken the care to address all of the regulatory requirements in our Type B meeting with the FDA and look forward to providing additional clarity as we receive confirmation from the FDA on our final development plan.”
Dr. Chamberland continued, “As we prepare to continue our clinical development work based on the feedback from the FDA, we are also preparing for commercialization and launch of CAUMZTM. This work requires we diligently prepare our manufacturing facilities, which includes scaling up to manufacture commercial batches of CAUMZTM and submitting commercial applications to the proper authorities in order to be ready to launch upon potential approval. As part of our strategic plan, we have added key personnel to important commercialization roles. I am pleased to welcome Dr. Melanie Kelly in the role of Chief Scientific Officer for Tetra. Melanie brings tremendous experience and will be instrumental in helping develop CAUMZTM. Additionally, I am thrilled to announce Steeve Néron has assumed the role of Chief Operating Officer after formerly having served as Senior Vice President of Marketing and Medical Affairs for Tetra.”
“We are diligently preparing for commercialization, with the appointments of key personnel, preparations in our manufacturing capabilities and plans on the regulatory front.” Mr. Chamberland concluded, “We look forward to additional updates as we continue to prepare for the launch of CAUMZTM.”
As part of its development strategy, Tetra initiated regulatory activities earlier this year to hold a Type B meeting with the FDA to request clarification on the nonclinical safety requirements for the submission of the marketing application (NDA) and supplemental marketing applications (sNDA), medical device requirements, eligibility for expedited review (i.e., fast track designation, breakthrough therapy designation, accelerated approval, or priority review designation) and marketing exclusivity for the drug and the Mighty Medic device. The Company expects the Type B meeting to be completed by the end of December 2019, and will provide an update to the market on the outcome of this meeting.
Tetra believes once it gains approval of CAUMZTM in patients with advanced cancer pain, it will continue the clinical development program in parallel and seek approval in breakthrough pain and fibromyalgia. The Company believes these supplemental applications will build on the marketing exclusivity anticipated to be obtained for CAUMZTM-Kit and significantly expand the target market size.
Tetra is currently in the process of formalizing its strategy on manufacturing CAUMZTM for the global market. The Company will provide the market with updates as significant developments are achieved. According to Dr. Chamberland, "Scale-up to commercial batch size is an important aspect for any pharmaceutical partner, and Tetra is already focusing efforts on manufacturing commercial batches of CAUMZTM to be able to submit the marketing applications and to be ready to launch the drug if approved."
Finally, Tetra announced that Dr. Melanie Kelly will join the team as Chief Scientific Officer. Dr. Kelly brings decades of experience in the fields of cannabinoid research and drug development. Additionally, the company is appointing Steeve Néron as Chief Operating Officer. Mr. Néron has previously served as Senior Vice President of Marketing and Medical Affairs.
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, 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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