Tetra Bio-Pharma (CSE:TBP) through its subsidiary, PhytoPain Pharma Inc., is pleased to announce that it has signed a Supply Agreement with Access to Cannabis for Medical Purpose Regulations (“ACMPR”) licensed producer Aphria Inc. (“Aphria”) (TSX VENTURE:APH)(OTCQB:APHQF) for the supply of dried medical cannabis as an Active Pharmaceutical Ingredient (API) for PPP’s inhalation cannabis product PPP001. PPP001 … Continued
Aphria is a Licensed Producer under the Access to Cannabis for Medical Purposes Regulations. Under this supply agreement with Aphria, PPP shall pursue the development of a prescription controlled inhalation drug product of medical marijuana and seek marketing approval across the world either directly or indirectly through partnerships or licensing agreements. Aphria will be the exclusive supplier of this API to PPP for the development and commercialisation of PP001.
PPP is granted an exclusive, non-transferrable, royalty free, licence to use the API in the development of PPP001. The agreement defines a purchase price during the clinical development and a volume rebate once a target volume is reached.
Both Canadian and USA prescription drug regulations impose rigorous quality systems for the manufacturing of both the API and finished drug product. These requirements include conformance to pharmaceutical Good Manufacturing Practice regulations (“GMP“) as well as demonstrating the ability of the manufacturer to ensure lot-to-lot consistency in the quality and safety of the prescription drug.
Dr. Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, PhytoPain Pharma Inc., commented, “We are very pleased and excited to be working with Aphria in the development of PPP001. Developing prescription botanical based pharmaceuticals requires a high quality GMP system and well-established product specifications to ensure consistent efficacy and ultimately protect the safety of patients. Based on our assessment of Aphria, we are confident that their high quality GMP medical cannabis production facility and impressive quality assurance team will meet or exceed the expectations of both the Canadian and USA prescription drug authorities.”
“With this agreement in place, PPP is now in a solid position to submit its Clinical Trial Application (CTA) for its planned Phase I trial in healthy volunteers. The company is also on track for submitting its Pre-IND Information Package for its upcoming meeting the US FDA,” stated Dr. Chamberland.
“Aphria is excited and proud to be an integral part of advancing the scientific research being led by Dr. Chamberland and the team at Tetra Bio-Pharma. Using our proprietary and high quality medical cannabis blend supported by high calibre research is exactly what professional healthcare practitioners require to gain the confidence to prescribe medical cannabis as a pharmaceutical,” said Vic Neufeld, Chief Executive Officer, Aphria Inc.
The Canadian Securities Exchange (CSE) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
Neither the TSX Venture Exchange (the “Exchange”) nor its Regulation Services Provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.
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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, 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.
Chief Executive OfficerTetra Bio-Pharma Inc.
VP Business Development and Communications
Tetra Bio-Pharma Inc.